Fioricet Oral

In the U.S.

• Anolor 300
• Dolgic LQ
• Esgic
• Esgic-Plus
• Ezol
• Fioricet
• Geone
• Margesic
• Medigesic
• Nonbac
• Pacaps
• Repan

Available Dosage Forms:

• Capsule
• Tablet
• Solution

Therapeutic Class: Butalbital/Acetaminophen Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

See also Warning section.

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.

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.

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.

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.

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.

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral liquid, oral tablet

Nervous system

Butalbital/Acetaminophen/Caffeine:
Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance

Caffeine:
Frequency not reported: Tremor[Ref]

General

The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Liver failure[Ref]

Acute liver failure has been reported with acetaminophen use; many case have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain
Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]

Renal

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Diuresis

Caffeine:
Frequency not reported: Nephrotoxicity[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis

Acetaminophen:
Postmarketing reports: Anaphylaxis[Ref]

Hematologic

Acetaminophen:
Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Dermatologic

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
Frequency not reported: Toxic epidermal necrolysis, erythema multiforme

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Frequency not reported: Rash[Ref]

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported.[Ref]

Respiratory

Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion[Ref]

Cardiovascular

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Tachycardia

Caffeine:
Frequency not reported: Cardiac stimulation[Ref]

Other

Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus[Ref]

Metabolic

Caffeine:
Frequency not reported: Hyperglycemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain, muscle fatigue[Ref]

Psychiatric

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Agitation, euphoria

Caffeine:
Frequency not reported: Irritability, dependence[Ref]

Some side effects of Fioricet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Fioricet is a combination tablet containing acetaminophen, butalbital, and caffeine.

Experts aren't sure exactly how acetaminophen works, but suspect it blocks a specific type of cyclo-oxygenase (COX) enzyme, located mainly in the brain.

Butalbital belongs to the class of medicines called barbiturates. When used for tension headaches it relaxes muscle contractions and causes sedation via an enhancement of the inhibitory effects of GABA (a neurotransmitter that regulates communication between brain cells).

Caffeine is thought to enhance the pain-relieving effects of acetaminophen by up to 40%. In addition, it has vasoconstrictive properties, narrowing blood vessels in the brain thereby decreasing blood flow and oxygen tension (before a headache or migraine, blood vessels tend to enlarge). This also helps to relieve pain.