Fioricet and Esgic is made from a combination of butalbital (a barbiturate, 50 mg), acetaminophen (325 mg), and caffeine (40 mg). They are indicated for the treatment of tension headaches and muscle contraction headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments. Note that Fioricet (and some other pain medications) are implicated as causing repeat headaches with over-use .

Important information about Fioricet

Do not use Fioricet if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Fioricet before the MAO inhibitor has cleared from your body.

Do not take more Fioricet than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together with Fioricet you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.

What should I discuss with my healthcare provider before taking Fioricet?

Butalbital may be habit-forming and should be used only by the person it was prescribed for. Fioricet should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take Fioricet without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

Before using Fioricet, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease,

• liver disease; or

• a history of mental illness or suicidal thoughts.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Fioricet.

FDA pregnancy category C. It is not known whether Fioricet is harmful to an unborn baby. Before taking Fioricet, tell your doctor if you are pregnant or plan to become pregnant during treatment. 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.

Fioricet side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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, stomach pain, low fever, 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.

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?

The following drugs can interact with Fioricet. Tell your doctor if you are using any of these:

• an antibiotic;

• a blood thinner such as warfarin (Coumadin);

• isoniazid;

• zidovudine (Retrovir, AZT);

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

• gout medications such as probenecid (Benemid) or sulfinpyrazone;

• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or

• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with Fioricet. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.