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Butalbital/acetaminophen/caffeine/codeine (By mouth)

Acetaminophen (a-seet-a-MIN-oh-fen), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een), Codeine Phosphate (KOE-deen FOS-fate)

Treats headaches. This medicine contains a narcotic pain reliever.

Brand Name(s):

Fioricet with Codeine

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to butalbital, acetaminophen, caffeine, or codeine, or if you have porphyria, severe breathing problems, or stomach blockage (including paralytic ileus).

How to Use This Medicine:

Capsule

  • Your doctor will tell you how much medicine to use. Do not use more than directed.
  • This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
  • This medicine is not for long-term use.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Do not throw unused medicine in the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
  • Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
    • Amiodarone, bupropion, carbamazepine, erythromycin, fluoxetine, ketoconazole, mirtazapine, paroxetine, phenytoin, quinidine, rifampin, ritonavir, tramadol, trazodone
    • Diuretic (water pill)
    • Medicine to treat anxiety, depression, or mental health problems
    • Phenothiazine medicine
  • Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
  • Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung or breathing problems (such as COPD), Addison disease, an enlarged prostate, trouble urinating, gallbladder problems, pancreas problems, an underactive thyroid, or stomach problems. Tell your doctor if you have a history of brain tumor, head injury, depression, seizures, or drug or alcohol addiction.
  • This medicine may cause the following problems:
    • High risk of overdose, which can lead to death
    • Respiratory depression (serious breathing problem that can be life-threatening)
    • Liver damage
    • Serious skin reactions
    • Serotonin syndrome (when used with certain medicines)
  • This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
  • This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
  • This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
  • Blistering, peeling, red skin rash
  • Blue lips, fingernails, or skin
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Extreme dizziness or weakness, trouble breathing, slow heartbeat, seizures, and cold, clammy skin
  • Severe confusion, lightheadedness, dizziness, fainting
  • Severe constipation or stomach pain

If you notice these less serious side effects, talk with your doctor:

  • Sleepiness, tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 10/4/2017
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