Fioricet side effects and drug information

Fioricet is a prescription medicine for the relief of tension headaches. It works by relaxing muscle contractions that can result in mild to moderate headaches.

Trade names Fioricet
US: C (Risk not ruled out)
Legal status In general: ℞ (Prescription only)
ChemSpider 17215772
KEGG D11561
Routes of
By mouth
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Fioricet is a combination of three ingredients: the pain reliever acetaminophen, the barbiturate butalbital, and the stimulant caffeine. The original formulation of Fioricet includes 50 mg of butalbital, 40 mg of caffeine and 325 mg of acetaminophen. In 2011, the FDA asked manufacturers of the drug to limit the amount of the medication to no more 325 mg in each tablet beginning in 2014. The action was taken to protect consumers from severe liver damage, a risk that is linked with taking too much acetaminophen

Fioricet is now available as a generic drug, produced by many drug manufacturers.

Side Effects

Fioricet has prescribed this medication because he has deemed that the benefit of the drug is greater than the risk of side effects. Many people who used the medication did not experience any serious side effects.

The common side effects of Fioricet include the following:

  • Nausea
  • Abdominal pain
  • Vomiting
  • Constipation
  • Dry mouth
  • Shaking
  • Increased urination
  • Shortness of breath
  • Dizziness
  • Lightheadedness
  • Trouble sleeping
  •  Drowsiness

If any of these side effects worsen or persist, report to your doctor immediately.

Immediately report to your doctor if you experience any of the following serious side effects:

  • Mental or mood changes
  • Seizures
  • Fainting
  • Fast or irregular heartbeat

Cases of a serious allergic reaction to this medication are rare. Report to your doctor or get medical help immediately if you experience any symptoms of a serious allergic reaction, such as itching or swelling, rash, trouble breathing, or severe dizziness.

Dosage and Administration

Fioricet should be taken exactly as prescribed by your doctor. You should follow all directions on the prescription label. Do not take more of Fioricet than recommended. 

Butalbital may be habit-forming. Never share Fioricet with another person, especially those who have a history of drug abuse or addiction. 

Take Fioricet with food or milk if you experience an upset stomach while taking it.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you must be aware if anyone is using your medicine improperly or without a prescription. 

The usual dose of Fioricet is one or 2 tablets every 4 hours as needed. The total daily dosage of Fioricet must not exceed 6 tablets.

Extended or repeated use of Fioricet is not advised due to its potential for physical dependence.

Drug Interaction

Drug interactions may alter how your medications work or increase the risk of serious side effects. Share with your doctor a list of all the medications you are currently taking, including prescription and nonprescription drugs, and herbal products so he could check for any interactions. Do not start, stop, or change the dosage of any medication without first getting the approval of your doctor.

Fioricet may interact with other drugs, including sodium oxybate, darunavir, drugs that affect liver enzymes, lithium, isoniazid, and phenothiazines. 

Fioricet can speed up the removal of other drugs from your body by affecting some liver enzymes, including blood thinners, doxycycline, felodipine, estrogen, quinidine, theophylline, some beta-blockers such as metoprolol, and corticosteroids such as prednisone.

Fioricet may decrease the effectiveness of hormonal birth controls such as pills, ring, or patch, which may cause pregnancy. 

This medication may interfere with certain laboratory tests, possibly causing false test results. Inform your laboratory personnel and your other healthcare professionals about your use of this drug.

Warning and Precautions

Before you start taking Fioricet, tell your doctor if you are allergic to butalbital, acetaminophen, caffeine, or other barbiturates. Fioricet may contain inactive ingredients that may trigger an allergic reaction or other problems. 

Before you start taking Fioricet, share with your doctor your medical history, especially if you ever had severe breathing problems, liver disease, kidney disease, a certain enzyme disorder, history of a substance use disorder, abdominal or stomach problems, and mental or mood disorders.

Fioricet may make you drowsy or dizzy. The use of alcohol or marijuana may make your dizziness or drowsiness worse. Do not drive, operate machinery, or perform any task that requires alertness until you are sure that you can do it safely. Avoid consuming alcoholic beverages. Discuss with your doctor your marijuana use.

Fioricet should not be used during pregnancy. The use of the drug by pregnant women should be resorted to only when clearly needed. It must not be used close to the delivery date because of possible harm to the unborn baby. 

Fioricet passes into breast milk and may have undesirable effects on a nursing infant. Discuss first with your doctor before you start breastfeeding while on this medication.

Overdose and Contraindications

Immediately call emergency medical services if someone has overdosed with Fioricet and has serious symptoms such as trouble breathing or passing out. If the overdose is not life-threatening, call your local poison control center immediately.

Fioricet is contraindicated under the following conditions:

  • Intolerance or hypersensitivity to any component of this product
  • Patients with porphyria

Clinical Pharmacology

Fioricet is a drug used for the treatment of tension headache. It is a fixed combination of butalbital, acetaminophen, and caffeine. The role that each component plays in relieving  the complex symptoms known as tension headache is not fully understood.

Medication Guide

Fioricet is a prescription medication used in the management of frequent or uncontrolled tension headaches. The drug may be helpful for someone who is struggling with tension headaches. The drug, however, must be used cautiously. Fioricet is a known drug of abuse that has the potential to bring about serious physical and mental health complications.

Anyone unable to control their use of Fioricet must consider substance abuse treatment. By consulting with an addiction professional or taking part in a substance abuse treatment, a person can quit using Fioricet safely and learn to address the behaviors and thoughts that keep them using despite the harm that doing so causes.

This drug is not recommended for long-term use because of its abuse potential.