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Fioricet contains a combination of acetaminophen, butalbital, and caffeine. Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Fioricet is used to treat tension headaches that are caused by muscle contractions.

Before taking Fioricet

Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

To make sure you can safely take Fioricet, tell your doctor if you have any of these other conditions:

• kidney disease,
• liver disease; or
• a history of mental illness or suicidal thoughts.

Butalbital may be habit forming and should be used only by the person it was prescribed for. 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.

FDA pregnancy category C. It is not known whether Fioricet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use Fioricet without telling your doctor if you are breast-feeding a baby.

Barbiturates in general have been reported to readily cross the placental barrier. Withdrawal seizures have been reported in a two day old infant whose mother had taken a butalbital containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. Animal reproduction studies have not been conducted on butalbital. Barbiturates are excreted in breast milk in small amounts. The significance of the effects on nursing infants has not been reported. Because of the potential for serious adverse reactions in nursing infants from butalbital, 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.

Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. 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.

Avoid drinking alcohol. It may increase your risk of liver damage while taking Fioricet due to the acetaminophen component.

Fioricet side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Fioricet and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;
• feeling light-headed or short of breath;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious Fioricet side effects may include:

• drowsiness;
• dizziness, confusion or lightheadedness;
• dry mouth;
• nausea, vomiting, stomach pain, loss of appetite;
• feeling anxious or jittery;
• drunk feeling; or
• headache.

Infrequently Observed Side Effects

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.

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.

What other drugs will affect Fioricet?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.

Tell your doctor about all other medicines you use, especially:

• an antibiotic;
• a blood thinner such as warfarin (Coumadin, Jantoven);
• isoniazid (for treating tuberculosis);
• zidovudine (Retrovir, AZT);
• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
• gout medications such as probenecid (Benemid) or sulfinpyrazone;
• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

   

  Common medications checked in combination with Fioricet (acetaminophen/butalbital/caffeine)

  Ambien (zolpidem) Cymbalta (duloxetine) Flexeril (cyclobenzaprine) hydrochlorothiazide Klonopin (clonazepam) lisinopril Lyrica (pregabalin) Neurontin (gabapentin) Nexium (esomeprazole) Prozac (fluoxetine)

  Singulair (montelukast) Soma (carisoprodol) Synthroid (levothyroxine) Topamax (topiramate) tramadol trazodone Vicodin (acetaminophen/hydrocodone) Vitamin D3 (cholecalciferol) Xanax (alprazolam) Zoloft (sertraline)

Fioricet Patient Reviews:

1.  I’ve had headaches since early childood and I swear I tried everything; OTC medicines, chiropractic, acupuncture, yoga, different diets, physical therapy, ultrasound. Finally after seeing a million doctors, including two neurologists and a pain specialist, I moved to a new state and started seeing a Physician’s Assistant, who prescribed me Fioricet. What a diffrence in my life. My headaches go away within an hour or so now, instead of just “waiting it out” for 3 to 6 days. I would tell anyone with TMJ and/or tension headaches to try this. It works best if you take it as soon as you feel a headache coming on. I too tried to use it as a last resort, but I have learned that it’s not worth the suffering.

2. I’ve learned to ‘live’ with headaches; often lasting up to four days or more. I was prescribed Fioricet about two years ago and I find it to be a relief not to have to ‘live’ with a headache for days anymore. I’m careful about using it and often as a last resort after trying Advil and the like. Therefore I don’t find it habit forming for me. It is an absolute relief drug.

3. I suffer from TMJ syndrome and sinusitis. I have recurring headaches. I have taken this drug on/off for 12 years. I am allergic to a lot of meds, so it’s been well-suited for me. I do know it is habit forming, as if I have to take it for several days, I do have some withdrawl symptoms.

4. I have been a suffering from migraine headaches for 20 years. I’ve tried EVERYTHING. My experience has shown if you take 2 tablets of Fioricet at the onset of one, you will do yourself a huge favor. It works. It may not eliminate your migraine but it will make it tolerable and less severe. Like others above, you have to be careful about how much you do take. I’ve found if I had a bad headache and have taken several pills, I have to then ween myself off of it by taking one pill every 4 hours over the next day or so to prevent a rebound headache. If you take many of these to relieve a headache, I recommend taking a few when your headache is gone to prevent a rebound. I make sure I carry my Fioricet with me at all times.

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