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Brand-name and generic medications

BAC is available under many brand names, of which Fioricet is the most common. Fioricet has:

• 50 milligrams (mg) of butalbital
• 300 mg of acetaminophen
• 40 mg of caffeine

Some combinations may also include codeine, an opiate used for pain. Codeine also carries a risk of addiction.

Different medications have different amounts of acetaminophen but generally the same amount of butalbital and caffeine.

Some BAC-containing medications include:

• Anolor 300
• Cephadyn
• Esgic
• Esgic-Plus, which has more acetaminophen than Esgic
• Fiorinal, which contains aspirin in place of acetaminophen
• Fioricet
• Fioricet with codeine
• Orbivan CF
• Phrenilin Forte

What is butalbital-acetaminophen-caffeine used for?

A doctor may prescribe BAC to help relieve symptoms of tension headaches. They may also prescribe the combination to treat migraine, though it’s not Food and Drug Administration (FDA)-approved for this use.

You should use BAC sparingly to prevent medication overuse headaches. Taking more medication than prescribed and for longer than prescribed can lead to these types of headaches, also called rebound headaches.

What are the side effects of butalbital-acetaminophen-caffeine?

Side effects of BAC can include:

• drowsiness
• upset stomach
• vomiting
• stomach pain
• depression
• lightheadedness
• confusion
• medication overuse headaches

Special considerations

If a doctor prescribes BAC to you, here are some things to keep in mind:

• It can make you drowsy. Use caution while driving and operating heavy machinery.
• Alcohol can add to the drowsiness.
• It can cause an upset stomach. Try taking it with food or milk.
• If you miss a dose, don’t take a double dose. Take a missed dose as soon as you remember. If you’re close to the next dose, take it then.
• Keep out of the reach of children to prevent accidental poisoning.
• It can cross into your breast milk if you’re nursing.
• It carries a risk of addiction if used more frequently or for longer than prescribed.

In pregnant people

An older study from 2014 found that women who used butalbital around the time of conception were more likely to deliver babies with some congenital heart defects. More research is needed before butalbital can be considered safe for pregnant people.

Often, headaches improve by the second or third trimester of pregnancy. If they don’t, talk with your healthcare team. They may suggest other interventions such as:

• lifestyle changes
• stress reduction
• ibuprofen
• acetaminophen

Small amounts of barbiturates and caffeine can make it into breast milk. Talk with a healthcare professional if you plan to breastfeed or chestfeed.

What is the proper dosage for butalbital-acetaminophen-caffeine?

BAC is available in capsules, tablets, or a liquid. The number of capsules or tablets you take varies by medication.

In capsule form, the recommended dosage is usually one to two pills every 4 hours as needed.

In liquid form, it’s usually 15 milliliters (mL) or 30 mL of oral suspension every 4 hours, up to a certain amount per day.

Be sure to read the prescription directions.

BAC can become habit-forming. To lower risk, doctors recommend that you do not:

• take a larger dose
• take it more often than a doctor prescribes
• take it for a longer period than a doctor prescribes

Use it exactly as directed and for a limited time. If you think you need more than the prescribed amount for your symptoms or need to take it for longer, contact your healthcare team to discuss.

Who should not use butalbital-acetaminophen-caffeine?

BAC is not for everyone. Your doctor may not prescribe BAC if:

• You’re allergic to acetaminophen, butalbital, or caffeine.
• You’re taking certain other medications, especially:
  • blood thinners such as warfarin (Coumadin)
  • some antidepressants
  • antihistamines
  • pain medications
  • sedatives, sleeping pills, or tranquilizers
  • certain vitamins
• You’re already taking medication that includes acetaminophen. Too much of this drug can damage your liver.
• You have or had liver disease, porphyria, or depression.
• You’re pregnant, plan to become pregnant, or are nursing.
• You drink alcohol, which adds to the drowsiness that BAC can cause.
• You’re a child. Experts don’t yet know the effects of this medication on developing brains.

Are there alternatives to butalbital-acetaminophen-caffeine?

If you’re not able to take BAC, a healthcare professional may suggest one or more of the following interventions:

• lifestyle changes, including staying hydrated, getting adequate sleep, and reducing stress
• over-the-counter medications such as aspirin, acetaminophen, or ibuprofen, with or without caffeine
• other prescription medications, depending on the underlying cause of your headache, such as:
  • ketorolac
  • naproxen
  • antidepressants
  • beta-blockers

Frequently asked questions

Is butalbital-acetaminophen-caffeine available over the counter?

No, BAC is only available by prescription. Your number of refills will also be limited.

Is butalbital-acetaminophen-caffeine available as a generic drug?

Yes, several of the prescriptions on the market are generics.

Is butalbital-acetaminophen-caffeine a controlled substance?

BAC on its own is not a federally controlled substance. Although it contains butalbital, it’s on the Drug Enforcement Agency (DEA)’s list of exempted prescription products. But some states do classify BAC as a controlled substance.

Other combinations that contain BAC or are similar to BAC may be controlled substances. The DEA classifies Fiorinal, which contains butalbital, aspirin, and caffeine, as a Schedule III drug. That means that there’s a low to moderate risk of dependence or overuse.

In April 2022, the DEA proposed removing the exemption for BAC. The proposed rule change would add all products that contain butalbital to its list of Schedule III controlled substances.

Do I need to take butalbital-acetaminophen-caffeine with food?

You don’t have to take BAC with food. Still, it can irritate your stomach. Taking BAC with food may lessen this side effect.

Can I take Fioricet with Tylenol?

Fioricet contains 300 mg of acetaminophen, the active ingredient in Tylenol. Taking Fioricet or any BAC product with Tylenol can have serious side effects. It can cause damage to your liver and other organs.

Also, be sure not to take more Fioricet than your doctor prescribed. This can also lead to acetaminophen overdose.

What makes a drug toxic to the liver?

Drug-induced liver injury is the most common cause of sudden liver failure in the United States and Europe. Liver toxicity is dose-dependent, meaning that higher doses are more likely to cause damage.

Some drugs are only known to cause liver damage at very high doses, whereas some can cause damage even at recommended dosages.

Drugs can cause three patterns of liver damage:

• Cholestatic: Injury results from the destruction of bile ducts and accumulation of bile. It tends to mimic bile duct obstruction or gallstones.
• Hepatocellular: Injury results from damage to cells called hepatocytes and causes symptoms similar to viral hepatitis. Hepatocytes make up 70% to 85% of your liver volume and perform most of your liver’s functions.
• Hepatocellular-cholestatic: Liver damage has features of both cholestatic and hepatocellular injury.

Most liver damage caused by medication is minor and temporary, but some people can develop serious liver diseases such as cirrhosis or liver failure. Liver failure can be life threatening and may need to be treated with a liver transplant.

People with drug-induced hepatocellular injury are 2 to 3 times more likely to need a liver transplant than people with cholestatic injury.

What types of drugs can cause liver damage?

Many types of drugs can cause liver damage. In a 2016 study published in the International Journal of Molecular Sciences, researchers found at least one report of liver toxicity in 53% of drugs in the National Institutes of Health’s LiverTox database.

In North America and Europe, the most common cause of toxic hepatitis is acetaminophen (Tylenol). Acetaminophen is harmless at low doses but can cause life threatening liver damage in high amounts.

Liver toxicity from acetaminophen usually occurs in suicide attempts at doses higher than 7.5 grams, and most often over 15 grams.

The researchers also found that more than 100 cases of liver injury were reported in the following medications:

• Antimicrobial drugs:
  • efavirenz
  • erythromycin
  • flucloxacillin
  • didanosine
  • interferon alpha/Peginterferon
  • nevirapine
• Antibiotics:
  • sulfamethoxazole/Trimethoprim
  • sulfazalazine
  • sulfonamides
  • amoxicillin-clavulanate
  • minocycline
  • telithromycin
  • nitrofurantoin
• Antifungal drugs:
  • ketoconazole
• Antiepileptic drugs:
  • carbamazepine
  • valproate
  • phenytoin
• Antineoplastic:
  • thioguanine
  • floxuridine
  • flutamide
• Antituberculosis drugs:
  • pyrazinamide
  • rifampin
  • isoniazid
• NSAIDs:
  • nimesulide
  • sulindac
  • ibuprofen
  • diclofenac
• Immunosuppressive agents:
  • infliximab
  • azathioprine/6-Mercaptopurine
  • methotrexate
  • gold salts
• Arrhythmia medications:
  • amiodarone
  • quinidine
• Antihypertensive medications:
  • methyldopa
  • hydralazine
• Lipid-lowering agents:
  • atorvastatin
  • simvastatin
• Bodybuilding drugs:
  • anabolic steroids
• Gout prophylaxis:
  • allopurinol
• Chemotherapy:
  • busulfan
• Other drugs:
  • estrogens and oral contraceptives
  • chlorpromazine (phenothiazine antipsychotics)
  • dantrolene (muscle relaxant)
  • disulfiram (substance abuse agent)
  • halothane (anesthetic)
  • interferon beta (multiple sclerosis)
  • ticlopidine (platelet inhibitor)
  • propylthiouracil (antithyroid)

Herbal supplements

Many people assume that herbal supplements are safe if they’re marketed as natural. However, many of these supplements can cause liver damage. Some herbal supplements linked to liver damage include:

• germander
• black cohosh
• kava extract
• green tea extract

Symptoms of liver toxicity

Symptoms of liver toxicity are similar to other liver diseases. They can include:

• jaundice
• dark urine
• fatigue
• weakness
• nausea
• poor appetite
• abdominal pain
• fever
• rash
• itching

Weakness and fatigue are prominent symptoms of hepatocellular injury. Jaundice and itching are typical symptoms of cholestatic injury.

It’s important to stop taking the medication as soon as possible after you develop symptoms.

What are the risk factors for liver toxicity?

According to research, you may be at an increased risk for developing drug-induced liver toxicity if you:

• are an older adult
• are born female
• are of African American descent
• consume a high level of alcohol over a long period of time, while using some types of drugs
• have certain genes

There’s debate about whether people with preexisting liver disease develop drug-induced liver illness more frequently. It has been found that they have a higher death rate.

How is liver toxicity diagnosed and treated?

There are no specific tests to diagnose drug-induced liver toxicity. To make a diagnosis, your doctor will consider your medical history and any drugs you’re taking. They’ll likely recommend blood tests to look for signs of liver damage and rule out other conditions. These tests often include:

• serum bilirubin test
• alanine aminotransferase test (ALT)
• aspartate aminotransferase test (AST)

Treatment for liver injury

In most cases, the only specific treatment needed is to stop taking the medication. High doses of acetaminophen need to be treated in the emergency room.

If you have severe symptoms of liver damage, it’s important to avoid:

• heavy exercise
• alcohol
• acetaminophen
• other substances that harm the liver

What can you do to lower your risk of liver damage when taking certain drugs?

You can reduce your chance of developing liver injury by closely following your doctor’s instructions for prescription medications and following the medication instructions for over-the-counter drugs. Your risk of developing toxicity increases at higher medication dosages.

Other things you can do include:

• talking with your doctor before you start taking herbal or dietary supplements
• telling your doctor about all the medications and supplements you’re currently taking
• closely reading the warnings and instruction information that comes with your medication
• reducing the use of nonessential medications
• visiting your doctor for regular checkups
• going to all your scheduled follow-ups

The bottom line

Many types of medications can cause liver injury. The most common cause of drug-induced liver injury in the United States is acetaminophen, usually at doses over 7.5 grams.

Common initial symptoms of drug-induced liver injury include jaundice, fatigue, and weakness. It’s important to contact your doctor right away if you develop signs of liver injury after starting a new medication. Usually, with mild cases, stopping the medication is the only treatment that’s necessary.