What are the possible side effects of Fioricet?
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 (Fioricet) may cause a severe skin reaction that can be fatal. This could occur even if you have taken Acetaminophen (Fioricet) 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 (Fioricet).
Stop using this medicine and call your doctor at once if you have:
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confusion, seizure (convulsions);
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shortness of breath;
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a light-headed feeling, like you might pass out; or
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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:
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drowsiness, dizziness;
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feeling anxious or restless;
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drunk feeling; or
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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.
Side effects of Fioricet in details
Frequently Observed
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
Infrequently Observed
All adverse events tabulated below are classified as infrequent.
Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of Butalbital (Fioricet).
Autonomic Nervous System: dry mouth, hyperhidrosis.
Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.
Cardiovascular: tachycardia.
Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis.
Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.
The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.
Acetaminophen (Fioricet): allergic reactions, rash, thrombocytopenia, agranulocytosis.
Caffeine (Fioricet): cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.
Drug Abuse And Dependence
Abuse and Dependence
Butalbital (Fioricet)
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.
What is the most important information I should know about Fioricet?
- Fioricet may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Fioricet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fioricet; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose, take more often than prescribed, or use for longer than prescribed without checking with your doctor.
- Pain medications work best if they are used as the first signs of pain (or migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.
- Fioricet has Acetaminophen (Fioricet) in it. Before you start any new medicine, check the label to see if it has Acetaminophen (Fioricet) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Fioricet may harm your liver. Your risk may be greater if you drink alcohol while you are using Fioricet. Talk to your doctor before you take Fioricet or other pain relievers/fever reducers if you drink alcohol.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Contact your doctor right away if you take more than 4,000 mg of Acetaminophen (Fioricet) per day, even if you feel well.
- Tell your doctor or dentist that you take Fioricet before you receive any medical or dental care, emergency care, or surgery.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Fioricet. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Fioricet may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Fioricet.
- Use Fioricet with caution in the ELDERLY; they may be more sensitive to its effects.
- Fioricet should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fioricet while you are pregnant. Fioricet is found in breast milk. Do not breast-feed while taking Fioricet.
When used for long periods of time or at high doses, Fioricet may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Fioricet stops working well. Do not take more than prescribed.
Some people who use Fioricet for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Fioricet suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, light-headedness, or seizures.
Fioricet contraindications
Fioricet is contraindicated under the following conditions:
− Hypersensitivity or intolerance to any component of this product.
− Patients with porphyria.
References
- DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Fioricet are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fioricet. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology