What Is Fioricet (Butalbital, Acetaminophen, Caffeine)

Fioricet is a prescription medication used to relieve tension headaches. It works by relaxing muscle contractions that can result in mild to moderate head pain.
Fioricet is a combination of three ingredients: the pain reliever acetaminophen; butalbital, a barbiturate; and caffeine, a stimulant.
The Food and Drug Administration (FDA) approved Fioricet in 1984. Novartis Pharmaceuticals was the original manufacturer. In 2003, Watson Pharmaceuticals bought the rights to Fioricet (Watson is now known as Actavis).
Fioricet is currently available from many manufacturers as a generic.
The original formulation of Fioricet included 50 milligrams (mg) of butalbital, 40 mg of caffeine, and 325 mg of acetaminophen.
However, in 2011 the FDA asked makers of prescription combination drugs with acetaminophen to limit the amount of that drug to no more than 325 mg in each tablet by 2014. This action was taken to protect consumers from severe liver damage, a risk linked with taking too much acetaminophen.
Today Fioricet includes 320 mg of acetaminophen, though some versions of the product sold online still have 325 mg.

The Fioricet 'High' and Abuse

The butalbital in Fioricet belongs to a class of drugs called barbiturates, a central nervous system depressant. Like other barbiturates, it has the potential to cause physical and psychological dependence, which can lead to abuse.
Those who use too much Fioricet may report feeling so relaxed and stress-free that they seek out the drug as a way to get high. Some describe it as feeling intoxicated. However, users can feel depressed and "crash" once the effects wear off.

Fioricet with Codeine

Another formula, Fioricet with codeine, is also made by Actavis to treat tension headaches. It contains 30 mg of codeine in addition to the other three drugs, and has an increased acetaminophen dose of 325 mg.
Fioricet with codeine carries a black-box warning about liver toxicity, and about the risk of respiratory problems and death in children caused by codeine.

Fioricet Warnings

Fioricet carries a black-box warning cautioning users about the link of acetaminophen to acute liver failure. In some cases, users of Fioricet have needed a liver transplant; in other cases, use of Fioricet has proven fatal.
Most problems have occurred with an acetaminophen dose of more than 4,000 mg a day. Those affected are often taking more than one product containing acetaminophen at the same time or have underlying liver disease.
Another caution concerns butalbital, which may be habit-forming and therefore has the potential to be abused.
Those with a condition known as porphyria, a rare hereditary blood disorder, should not use Fioricet.

Pregnancy and Fioricet

Fioricet is in Pregnancy Category C, according to the FDA, which means that injury to the developing fetus cannot be ruled out. Even so, the benefits of the drug to the mother must be weighed against the potential risk to the unborn baby.
All three drugs found in Fioricet are found in small amounts in human milk, but the significance of that is not known.
You should discuss with your doctor whether to stop breastfeeding or stop taking the drug, weighing the benefits against the costs.

Fioricet (Butalbital, Acetaminophen, Caffeine) Side Effects

Like all medicines, Fioricet can have side effects.

Common Side Effects of Fioricet

Among the most commonly reported:
  • Drowsiness
  • Lightheadedness, dizziness
  • Feeling short of breath
  • Nausea, vomiting, stomach pain
  • Feeling of intoxication

Severe Side Effects of Fioricet

If you have any of the following symptoms, contact your doctor right away or go to the closest emergency room:
  • Skin rash
  • Itching
  • Breathing problems

Rare Side Effects of Fioricet

Other side effects of Fioricet are infrequent. Among these are:
  • Dry mouth, swallowing problems
  • Gas, constipation, heartburn
  • Leg pain or fatigued muscles
  • Fever

Fioricet (Butalbital, Acetaminophen, Caffeine) Interactions

The effects of one or more of the drugs in Fioricet may enhance the effects of other drugs. These may include:
  • Monoamine oxidase inhibitors (MAOIs), antidepressants including Marplan (isocarboxazid), Nardil (phenelzine), and others
  • Tranquilizers such as chlordiazepoxide (Librium)
  • Sedative-hypnotics, such as prescription sleeping pills
  • General anesthesia drugs
Remember to always tell your doctor about any prescription, non-prescription, over-the-counter (OTC), illegal and recreational drugs, herbal remedies, nutritional and dietary supplements, and all other drugs and treatments you're taking.

Fioricet and Alcohol

Ask your doctor about whether to avoid alcohol while taking Fioricet. The drug may enhance the intoxicating effects of alcohol. Drinking while on Fioricet may increase the risk of liver damage from the acetaminophen.

Fioricet (Butalbital, Acetaminophen, Caffeine) Dosage

The recommended dose:
  • 1 to 2 capsules every 4 hours as you need it for pain
  • Do not take more than 6 capsules daily.
You should not use Fioricet long term, due to the possibility for physical dependence and abuse.

Fioricet Overdose

If you overdose on Fioricet, toxicity is more likely to result from the butalbital and acetaminophen than the caffeine, since it is present in relatively small amounts.
If you are affected by confusion or extreme drowsiness or other worrisome symptoms, contact your doctor right away or go to the closest emergency room.

Missed Dose of Fioricet

If you miss a scheduled dose, take it when you remember it. However, if it is nearly time for the next dose, just resume your regular medication schedule. Never double up on doses.

Fioricet Pictures

Fioricet, blue, round,
APAP-BUT-CAFF-QUA, white, oblong,
APAP-Butalb-Caffeine 325-50-40 mg Tab-MAL, white, round,
APAP-Butalbital-Caffeine 325-50-40 mg-WAT, white, oblong,
Fiorpap, blue, round,