Nausea, vomiting, abdominal pain, constipation, dry mouth, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, fainting, seizures, fast/irregular heartbeat.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Lightheadedness
shortness of breath
Incidence not known
Abdominal or stomach pain
black, tarry stools
bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
blurred vision
change in the frequency of urination or amount of urine
chills
cough
diarrhea
difficulty with breathing
difficulty with swallowing
dizziness
drowsiness
dry mouth
fainting
fast, pounding, or irregular heartbeat or pulse
flushed or dry skin
fruit-like breath odor
hives, itching, or skin rash
increased hunger
increased thirst
increased urination
joint or muscle pain
loss of appetite
nausea or vomiting
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
seizures
shakiness in the legs, arms, hands, or feet
sore throat
sores, ulcers, or white spots in the mouth or on the lips
sweating
swelling of the feet or lower legs
tightness in the chest
trembling or shaking of the hands or feet
troubled breathing
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Confusion as to time, place, or person
dark urine
difficult or painful urination
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fever
general feeling of discomfort or illness
hallucinations
headache
holding false beliefs that cannot be changed by fact
increased sweating
irregular, fast or slow, or shallow breathing
light-colored stools
loss of appetite
pale or blue lips, fingernails, or skin
restlessness
sudden decrease in the amount of urine
sweating
trouble sleeping
unpleasant breath odor
unusual excitement, nervousness, or restlessness
vomiting of blood
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Relaxed and calm
sleepiness
Incidence not known
Anxiety
bloated
constipation
continuing ringing or buzzing or other unexplained noise in the ears
depression
earache
excess air or gas in the stomach or intestines
false or unusual sense of well-being
full feeling
hearing loss
heartburn
heavy eyelids
high energy
hot spells
hyperventilation
irritability
numbness
pain in the leg
passing gas
sluggishness
stuffy nose
tingling sensation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Take Fioricet by mouth with or without food as directed by your doctor, usually every 4 hours as needed.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Buy Fioricet Online
The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.
If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.
Fioricet is a prescription medicine that’s used to relieve tension headaches primarily because it relaxes the muscle contractions that cause head pain, ranging in severity from mild to moderate in most cases.
A tension headache is different from a migraine because as was touched on above, it’s believed that migraines stem from neurological issues, whereas a tension headache is often the result of triggers like stress, bad posture, or tension in the muscles of the neck and shoulders. Tension headaches don’t necessarily affect your vision, strength or balance, but a true migraine can affect all of these things. Migraines can also cause nausea and vomiting.
Additionally, tension headaches don’t have a genetic component, whereas migraines often run in families.
All of these distinctions are important to recognize when considering what Fioricet is used for, and why it’s not necessarily the best treatment option for migraines.
Fioricet contains three primary ingredients which are butalbital, acetaminophen, and caffeine.
Butalbital is a barbiturate, and it can relieve muscular tension by acting as somewhat of a muscle relaxant, and it can also relieve pain because it acts on the central nervous system. Along with releasing muscle contractions, butalbital can also create a sense of relaxation and relieve symptoms of anxiety. The acetaminophen acts as a pain reliever, and the caffeine can open up the flow of blood through blood vessels, which is thought to help with some headache pain.
So, with all that being said, people wonder if Fioricet is used for headaches, can it also be used for migraines?
Important information
You should not use Fioricet if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
Do not use Fioricet if you have taken a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death.Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Fioricet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Before taking this medicine
Do not use Fioricet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
You should not use Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
To make sure Fioricet is safe for you, tell your doctor if you have:
liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
kidney disease;
asthma, sleep apnea, or other breathing disorder;
stomach ulcer or bleeding;
a history of skin rash caused by any medication;
a history of mental illness or suicidal thoughts; or
if you use medicine to prevent blood clots.
It is not known whether Fioricet will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
What Are Side Effects of Fioricet ?
Fioricet is a combination medication containing acetaminophen, butalbital, and caffeine, commonly prescribed for tension headaches and certain types of migraines. Like any medication, Fioricet can cause side effects, which may vary in severity and frequency among individuals. Here are some potential side effects associated with Fioricet:
Drowsiness: Butalbital, a barbiturate found in Fioricet, can cause drowsiness or sedation, which may impair your ability to drive or operate machinery. It’s important to avoid activities that require alertness until you know how Fioricet affects you.
Dizziness: Fioricet may cause dizziness or lightheadedness, especially when standing up quickly from a sitting or lying position. Take care when changing positions to minimize the risk of falls or injury.
Nausea and vomiting: Some individuals may experience nausea or vomiting as a side effect of Fioricet. Taking the medication with food or a glass of milk may help reduce gastrointestinal discomfort.
Stomach upset: Fioricet contains acetaminophen, which can irritate the stomach lining in some people, leading to stomach upset or abdominal pain. Taking the medication with food or an antacid may help alleviate stomach discomfort.
Constipation: Butalbital, a component of Fioricet, can cause constipation in some individuals. Increasing fluid intake, dietary fiber, and physical activity may help prevent or relieve constipation.
Confusion or impaired cognition: Butalbital, especially when taken in high doses or for a prolonged period, may cause confusion, impaired cognition, or difficulty concentrating. If you experience these symptoms, avoid activities that require mental alertness until they resolve.
Dependency and withdrawal: Fioricet contains butalbital, which is a barbiturate and can be habit-forming if used excessively or for an extended period. Abruptly stopping Fioricet after long-term use may cause withdrawal symptoms such as rebound headaches, anxiety, insomnia, tremors, or seizures. It’s essential to use Fioricet as directed by your healthcare provider and avoid prolonged use or abrupt discontinuation without medical supervision.
Allergic reactions: In rare cases, Fioricet may cause allergic reactions such as skin rash, itching, swelling of the face or throat, difficulty breathing, or anaphylaxis. Seek immediate medical attention if you experience signs of an allergic reaction.
Liver toxicity: Fioricet contains acetaminophen, which can cause liver damage or liver failure if taken in high doses or for a prolonged period. It’s important to adhere to the recommended dosage instructions and avoid exceeding the maximum daily dose of acetaminophen.
Other side effects: Other less common side effects of Fioricet may include heart palpitations, rapid heartbeat, mood changes, depression, and difficulty urinating.
If you experience any concerning side effects while taking Fioricet, contact your healthcare provider for further evaluation and guidance. They can help determine whether Fioricet is the right medication for you and recommend appropriate management strategies to minimize side effects.
How should I take Fioricet?
Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Butalbital may be habit-forming. Never share Fioricet with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Fioricet is against the law.
Take Fioricet with food or milk if it upsets your stomach.
Store Fioricet at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Fioricet may be used as a migraine treatment, but it’s not a first or even second choice among physicians. There are a few reasons. First, as was touched on above, Fioricet is primarily used for the treatment of tension headaches, which are very different from migraines. A lot of doctors feel that Fioricet doesn’t even necessarily work on migraine pain. There are a lot of other treatment options that are more specifically for the treatment of migraines, and they work in ways that are different from Fioricet.
According to the FDA, Fioricet isn’t approved for the treatment of migraines at all. It may have some benefits for migraine sufferers in that it can provide them with a sense of physiological calmness because of how it works on the central nervous system, but there again are better ways to treat migraines.
Another reason Fioricet isn’t necessarily an ideal migraine treatment is because of the risks that come with it.
Butalbital is a substance that can be habit-forming, and the use of Fioricet has actually led to addiction problems and physical dependence for some of the people who use it. It may be a prescription medicine, but that certainly doesn’t mean it’s risk-free.
Another risk associated with the use of Fioricet is the potential for liver toxicity from acetaminophen. Acetaminophen taken in large doses can result in liver injury and failure, and it has to be taken carefully and only as prescribed.
So, to sum up, what is Fioricet used for? The FDA approves the use of this prescription medication for the treatment of tension headaches primarily, as well as something called a post-dural puncture headache, which can occur following something like anesthesia administered in the spine. The FDA doesn’t approve Fioricet for the treatment of migraine headaches, both because it’s not the most effective available treatment option, and also because there are risks that come with the use of Fioricet including addiction, dependence and side effects like potential liver toxicity.
Fioricet dosing information
Usual Adult Dose of Fioricet for Headache:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg: 1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.
Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg: 1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours. Maximum daily dose: 6 doses
Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg: 1 tablet or capsule orally every 4 hours. Maximum daily dose: 6 doses
Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg: 1 tablet orally every 4 hours. Maximum daily dose: 5 tablets
Usual Pediatric Dose of Fioricet for Headache:
12 years and older: Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg: 1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.
See also:
What happens if I miss a dose?
Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.
What should I avoid while taking Fioricet?
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.
Fioricet side effects
Get emergency medical help if you have signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop using this medicine and call your doctor at once if you have:
confusion, seizure (convulsions);
shortness of breath;
a light-headed feeling, like you might pass out; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Fioricet side effects may include:
drowsiness, dizziness;
feeling anxious or restless;
drunk feeling; or
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Fioricet?
Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Fioricet with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Butalbital, acetaminophen and caffeine (Fioricet)are supplied in capsule form for oral administration.
Each capsule contains:
Butalbital ……………….. 50 mg
Warning: May be habit-forming.
Acetaminophen ………. 325 mg
Caffeine …………………. 40 mg
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate added as manufacturing aides to the gelatin) and titanium dioxide. Impriting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
Fioricet is a prescription pain medicine used to treat the symptoms of tension headache.
Fioricet may be used alone or with other medications.
Fioricet is an analgesic barbiturate combo.
It is not known if Fioricet is safe and effective in children younger than 12 years of age.
Acetaminophen Warning
What are the possible side effects of Fioricet?
Fioricet may cause serious side effects including:
suddenly appearing rash,
swelling of face, mouth or throat,
difficulty breathing,
vomiting ,
hives,
itching ,
fever,
diarrhea,
dark colored urine,
yellowing of eyes and skin (jaundice),
headache,
nausea,
stomach pain,
weight loss,
white or gray stool,
fatigue,
dehydration ,
abdominal upset,
skin changes,
sudden high blood pressure, and
convulsions (seizures),
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Fioricet include:
drowsiness,
lightheadedness,
dizziness,
shortness of breath,
nausea,
vomiting,
abdominal pain, and
feeling intoxicated
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Fioricet. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Information For Patients /Caregivers
Do not take Esgic® Capsules if you are allergic to any of its ingredients.
If you develop signs of allergy such as a rash or difficulty breathing, stop taking Esgic® Capsules and contact your healthcare provider immediately.
Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
How is Fioricet Used ?
Fioricet is typically used to treat tension headaches and certain types of migraines. It is a combination medication that contains three active ingredients: acetaminophen, butalbital, and caffeine. Here’s how Fioricet is typically used:
Dosage: Fioricet comes in tablet or capsule form, and the dosage may vary depending on the specific formulation and the severity of the headache being treated. The typical adult dosage of Fioricet is one to two tablets or capsules every four hours as needed, not to exceed six tablets or capsules in a 24-hour period.
Administration: Fioricet should be taken orally with a full glass of water. It can be taken with or without food, although taking it with food or milk may help reduce the risk of stomach upset.
Timing: Fioricet is usually taken at the onset of headache symptoms or as directed by a healthcare provider. It is important to take Fioricet as soon as possible after the onset of symptoms to maximize its effectiveness in relieving headache pain.
Frequency of use: Fioricet is intended for short-term use to relieve acute headache symptoms. It should not be used for more than a few days in a row, as prolonged or excessive use can lead to tolerance, dependence, and rebound headaches.
Avoiding overuse: To minimize the risk of medication overuse headaches or rebound headaches, it’s important to use Fioricet only as needed and to avoid using it more frequently or at higher doses than prescribed. If headaches persist or worsen despite Fioricet use, consult with a healthcare provider for further evaluation and management.
Monitoring for side effects: While Fioricet can be effective in relieving headache pain, it can also cause side effects, including drowsiness, dizziness, nausea, vomiting, and stomach upset. Monitor for any adverse reactions while taking Fioricet and contact a healthcare provider if you experience severe or persistent side effects.
Interaction with other medications: Fioricet may interact with certain medications, including other pain relievers, sedatives, muscle relaxants, antidepressants, and medications containing acetaminophen. It’s important to inform your healthcare provider about all medications, supplements, and herbal remedies you are taking to avoid potential interactions.
Storage: Store Fioricet at room temperature away from moisture, heat, and light. Keep it out of reach of children and pets, and dispose of any unused medication properly according to local regulations.
Always use Fioricet as directed by a healthcare provider and follow the recommended dosage instructions to ensure safe and effective treatment of tension headaches or migraines. If you have any questions or concerns about how to use Fioricet, consult with a healthcare provider for personalized guidance.
Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
Fioricet Overdose Treatment
Signs of Fioricet Overdose
Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.
What are the Symptoms of Fioricet Overdose ?
Fioricet contains three active ingredients: acetaminophen, butalbital, and caffeine. Overdose of Fioricet can lead to serious and potentially life-threatening complications, particularly due to the presence of acetaminophen, which can cause liver damage in high doses. Here are the symptoms of a Fioricet overdose:
Acetaminophen toxicity: Acetaminophen overdose is the most concerning aspect of Fioricet overdose. Symptoms of acetaminophen toxicity may not be immediately apparent but can develop within hours to days after ingestion. These symptoms may include:
Nausea and vomiting
Loss of appetite
Abdominal pain or discomfort, particularly in the upper right side
Yellowing of the skin or eyes (jaundice)
Dark urine
Clay-colored stools
Confusion or altered mental status
Coma
Acetaminophen overdose can lead to liver failure, which can be fatal if not promptly treated. Liver damage may progress over several days, and early medical intervention is crucial to prevent severe complications.
Butalbital toxicity: Butalbital is a barbiturate found in Fioricet, and overdose can lead to central nervous system depression, respiratory depression, and other serious complications. Symptoms of butalbital overdose may include:
Drowsiness
Confusion
Slurred speech
Impaired coordination
Respiratory depression (shallow breathing)
Hypotension (low blood pressure)
Coma
Caffeine toxicity: While less common, overdose of caffeine can lead to symptoms such as:
Restlessness
Anxiety
Rapid heartbeat (tachycardia)
Tremors
Seizures (in severe cases)
If you suspect a Fioricet overdose or experience symptoms of overdose, seek immediate medical attention or contact your local poison control center. Prompt medical treatment is essential to prevent serious complications and improve outcomes.
Treatment of Fioricet Overdose
A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.
Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
How to Treat Fioricet Overdose ?
Treating Fioricet overdose involves prompt medical intervention to address the symptoms and prevent potentially life-threatening complications. If you suspect a Fioricet overdose or experience symptoms of overdose, seek immediate medical attention by calling emergency services or going to the nearest emergency room. Here are the steps typically involved in treating Fioricet overdose:
Assessment and stabilization: Upon arrival at the hospital, medical professionals will conduct a thorough evaluation to assess the severity of the overdose and stabilize the individual’s condition. This may involve monitoring vital signs, administering oxygen therapy, and providing intravenous fluids to maintain hydration and support circulation.
Activated charcoal: If the Fioricet overdose occurred within a few hours, healthcare providers may administer activated charcoal orally or through a nasogastric tube. Activated charcoal can help absorb and prevent further absorption of any remaining medication in the stomach.
Acetaminophen antidote: Acetylcysteine (Mucomyst) is the antidote for acetaminophen overdose and is typically administered intravenously to prevent or minimize liver damage. Acetylcysteine works by replenishing depleted glutathione levels in the liver and protecting against toxic metabolites of acetaminophen.
Supportive care: Healthcare providers will provide supportive care to manage symptoms and complications of Fioricet overdose. This may include:
Monitoring vital signs and oxygen saturation
Administering medications to address symptoms such as nausea, vomiting, or respiratory depression
Providing mechanical ventilation or respiratory support if necessary
Monitoring liver function tests to assess for signs of liver damage or failure
Correcting electrolyte imbalances or other metabolic disturbances
Administering intravenous fluids to maintain hydration and support kidney function
Monitoring and observation: Individuals who have overdosed on Fioricet may require close monitoring and observation in the hospital, particularly if they are at risk of developing complications such as liver failure or respiratory depression. Healthcare providers will monitor the individual’s condition and response to treatment, adjusting interventions as needed.
Psychiatric evaluation: In cases of intentional overdose or suspected substance abuse, individuals may benefit from a psychiatric evaluation to assess for underlying mental health issues and provide appropriate support and interventions.
One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.
Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.
Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.
What Fioricet is Used For ?
This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.
Other Usages of Fioricet
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used for migraine headaches.
How to use Fioricet ?
Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.
If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.
Side Effects of Fioricet
Nausea, vomiting, abdominal pain, constipation, dry mouth, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including:
mental/mood changes
fainting
seizures
fast/irregular heartbeat
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
rash
itching/swelling (especially of the face/tongue/throat)
severe dizziness
trouble breathing
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precaution of Taking Fioricet
Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
severe breathing problems (such as bronchopneumonia)
a certain enzyme disorder (porphyria)
liver disease
kidney disease
personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
mental/mood disorders
abdominal/stomach problems (such as stomach ulcer)
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Liquid products may contain alcohol, sugar and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness and trouble falling asleep. These side effects can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/nonstop crying, vomiting, seizures, or diarrhea. Tell your doctor right away if you notice any of these symptoms in your newborn.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Fioricet Drug Interaction
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include:
darunavir
sodium oxybate
isoniazid
ketoconazole
levoketoconazole
lithium
phenothiazines (such as chlorpromazine)
This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include doxycycline, estrogen, felodipine, lonafarnib, quinidine, rilpivirine, tamoxifen, theophylline, voriconazole, “blood thinners” (such as warfarin), certain beta blockers (such as metoprolol), corticosteroids (such as prednisone), among others.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain caffeine or ingredients that cause drowsiness. Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine. Ask your pharmacist about using those products safely.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Overdose of Taking Fioricet
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, severe dizziness, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine.
Storage of Fioricet
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Is Fioricet Considered a Narcotic?
Most people will say yes although maybe not in the strictest terms, but if it contains codeine, it is absolutely a narcotic.
Is Fioricet considered a narcotic? This is a common question people have about this prescription headache medicine. Below is an overview of what a narcotic is and information about Fioricet including whether or not it’s considered a narcotic.
What is a Narcotic?
Before exploring if Fioricet is a narcotic, what is a narcotic? The term narcotic was at one point in history used to refer to any psychoactive substance that tended to induce sleep, but currently, in the U.S., it’s primarily associated with opioids including heroin, as well as prescription painkillers.
When you’re looking at the term narcotic in the legal sense, people often associate it with illegal drugs like heroin, but a narcotic can also be used to describe controlled substances such as painkillers that are regulated but available by prescription.
In the U.S. there are classifications for various narcotics that define the penalties for possessing the illegally, including without a prescription.
So, is Fioricet a narcotic?
Fioricet Ingredients
In regular Fioricet there are three primary, active ingredients These are butalbital, which is a barbiturate, acetaminophen which is a painkiller available over-the-counter, and caffeine. These three ingredients are meant to work together to relieve headache pain and similar symptoms.
When considering whether Fioricet is a narcotic, the primary ingredient to look at is the butalbital, because the other two ingredients would never be considered narcotics.
Butalbital is a barbiturate with an intermediate duration of action, and it’s FDA approved for the use as a treatment for tension headaches. Despite its effectiveness in treating headaches, particularly of the tension variety, it’s not the first option. Butalbital can cause problems with alertness, and there’s the risk for dependence and addiction. Some people describe the effects of Fioricet as making them feel drunk.
Legally in the U.S., barbiturates of all kinds are Schedule IV.
Features of Schedule IV drugs according to the United States Controlled Substance Act include:
There is a relatively low potential for abuse compared to substances that are classified as Schedule III
The substance has a currently accepted medical use in the U.S.
With abuse of a Schedule IV drug, there is a limited potential that physical or psychological dependence could occur
It could be considered by some to be a narcotic, but usually the term narcotic refers to opioids, which will be discussed below.
Fioricet with Codeine
There is a version of Fioricet that has all of the ingredients listed above but also includes codeine. Codeine is completely classified as a narcotic in the U.S, and it’s a controlled substance. Codeine is not only a narcotic pain reliever but also a cough suppressant, and it’s similar in many ways to morphine and hydrocodone.
When someone takes a drug with codeine, it binds to opioid receptors, changing how the person perceives pain. It increases pain tolerance, and it can also depress the central nervous system. Codeine is frequently paired with acetaminophen or aspirin to be even more effective as a painkiller.
To sum up, is Fioricet a narcotic? Most people will say yes although maybe not in the strictest terms, but if it contains codeine, it is absolutely a narcotic.
Fioricet Warnings
As with other narcotics and prescription pain medicines, Fioricet has many warnings that accompany its use.
First and foremost, this medicine can cause liver toxicity because of the acetaminophen. It’s important that people realize that they should never take an excessive amount of acetaminophen in one day because it can lead to liver damage or failure. Also, while it may be somewhat lower than with other narcotics, there is the potential for abuse, addiction, and dependence with the use of barbiturates including butalbital.
Butalbital is habit-forming and potentially abusable.
Consequently, the extended use of this product is not recommended.
hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is high in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
serious skin reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
hypersensitivity / anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Fioricet immediately and seek medical care if they experience these symptoms. Do not prescribe Fioricet for patients with acetaminophen allergy.
Precautions
general
Fioricet should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
information for patients
This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.
Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
For information on use in geriatric patients, (see PRECAUTIONS/Geriatric Use).
Do not take Fioricet if you are allergic to any of its ingredients.
If you develop signs of allergy such as a rash or difficulty breathing stop taking Fioricet and contact your healthcare provider immediately.
Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
laboratory tests
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
drug interactions
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
drug / laboratory test interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
carcinogenesis, mutagenesis, impairment of fertility
No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.
pregnancy
teratogenic effects
Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.
nonteratogenic effects
Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
nursing mothers
Caffeine, butalbital, acetaminophen, and caffeine, and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen, and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
pediatric use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
geriatric use
Clinical studies of butalbital, acetaminophen, and caffeine capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg.
As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller.
The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.
Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.
