Butalbital

Acetaminophen, butalbital, caffeine, and codeine

Generic Name: acetaminophen, butalbital, caffeine, and codeine (a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen)
Brand Name: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

What is this acetaminophen, butalbital, caffeine, and codeine?

Codeine is an opioid pain medication (sometimes called a narcotic). Acetaminophen is a less potent pain reliever. Butalbital is a barbiturate that relaxes muscle contractions. Caffeine is a stimulant that relaxes blood vessels to improve blood flow.

Acetaminophen, butalbital, caffeine, and codeine is a combination medicine used to treat tension headaches.

Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes not listed in this medication guide.

Important Information

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to acetaminophen, butalbital, caffeine, or codeine, or if you have:

  • severe asthma or breathing problems;
  • a blockage in your stomach or intestines;
  • porphyria; or
  • if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

This medicine is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Tell your doctor if you have ever had:

  • a head injury, or seizures;
  • liver or kidney disease;
  • urination problems;
  • problems with your gallbladder, thyroid, or adrenal gland; or
  • alcoholism, drug addiction, or mental illness.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

How should I take acetaminophen, butalbital, caffeine, and codeine?

Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Since acetaminophen, butalbital, caffeine, and codeine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or another person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What should I avoid while taking acetaminophen, butalbital, caffeine, and codeine?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking too much acetaminophen can lead to a fatal overdose.

acetaminophen, butalbital, caffeine, and codeine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing;
  • a slow heart rate or weak pulse;
  • extreme drowsiness, feeling like you might pass out;
  • chest pain, fast or pounding heart rate, feeling short of breath;
  • confusion, unusual thoughts or behavior;
  • low cortisol levels– nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • liver problems–nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects include:

  • drowsiness, dizziness, feeling “drunk”;
  • headache, tiredness; or
  • nausea, vomiting, stomach pain, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Acetaminophen, butalbital, caffeine, and codeine dosing information

Usual Adult Dose for Headache:

1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Comments:
-Because of the risks of addiction, abuse, and misuse, prescribing should be reserved to patients for whom alternative options have not been tolerated or are not expected to be tolerated; and for patients for whom alternative options have not provided adequate analgesia or are not expected to provide adequate analgesia.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache when nonopioid analgesic and alternative treatments are inadequate.

What other drugs will affect acetaminophen, butalbital, caffeine, and codeine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
  • medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
  • other narcotic medications–opioid pain medicine or prescription cough medicine;
  • a sedative like Valium–diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
  • drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
  • drugs that affect serotonin levels in your body–a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect acetaminophen, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

For the Consumer

Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule

Along with its needed effects, acetaminophen/butalbital/caffeine/codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen/butalbital/caffeine/codeine:

Less Common

  • Confusion (mild)
  • mental depression
  • unusual excitement (mild)

Rare

  • Bleeding or crusting sores on the lips
  • chest pain
  • fever with or without chills
  • hive-like swellings on the eyelids, face, lips, or tongue
  • hives, itching, or skin rash
  • muscle cramps or pain
  • red, thickened, or scaly skin
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sore throat
  • sores, ulcers, or white spots in the mouth
  • swollen or painful glands
  • tightness in the chest
  • troubled breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen/butalbital/caffeine/codeine:

Symptoms of Overdose

  • Anxiety (severe)
  • cold and clammy skin
  • confusion (severe)
  • dizziness, lightheadedness, drowsiness, or weakness (severe)
  • excitement (severe)
  • increased sleepiness in babies (more than usual)
  • increased sweating
  • irritability (severe)
  • limpness (in babies)
  • nausea
  • restlessness (severe)
  • slow, fast, or irregular heartbeat
  • slurred speech
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area
  • trembling or shaking of the hands or feet
  • trouble sleeping (severe)
  • unusually slow or troubled breathing
  • vomiting

Some side effects of acetaminophen / butalbital / caffeine / codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Bloated or “gassy” feeling
  • dizziness or lightheadedness (mild)
  • drowsiness (mild)

For Healthcare Professionals

Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule

General

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

Hepatic

Acetaminophen:

Frequency not reported: Liver failure

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

Respiratory

Common (1% to 10%): Shortness of breath

Uncommon (0.1% to 1%): Nasal congestion

Codeine:

Postmarketing reports: Respiratory depression including deaths

Respiratory depression resulting in death has been reported in children who received codeine postoperatively following tonsillectomy and/or adenoidectomy. These children had evidence of being ultra-rapid metabolizers of codeine. Death has also been reported in nursing infants exposed to high levels of morphine in breast milk due to their breastfeeding mother being an ultra-rapid metabolizer of codeine.

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions

Postmarketing reports: Anaphylaxis

Acetaminophen:

Postmarketing reports: Anaphylaxis

Dermatologic

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported with butalbital/acetaminophen/caffeine.

Butalbital/Acetaminophen/Caffeine/Codeine:

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

Psychiatric

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Agitation, euphoria

Caffeine:

Frequency not reported: Irritability, dependence

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain

Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation

Renal

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Diuresis

Caffeine:

Frequency not reported: Nephrotoxicity

Hematologic

Acetaminophen:

Frequency not reported: Thrombocytopenia, agranulocytosis

Cardiovascular

Butalbital/Acetaminophen/Caffeine/Codeine:

Uncommon (0.1% to 1%): Tachycardia

Caffeine:

Frequency not reported: Cardiac stimulation

Nervous system

Butalbital/Acetaminophen/Caffeine/Codeine:

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

Opioids:

Frequency not reported: Serotonin syndrome (with concomitant serotonergic drugs)

Other

Common (1% to 10%): Intoxicated feeling

Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus

Metabolic

Caffeine:

Frequency not reported: Hyperglycemia

Musculoskeletal

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

Endocrine

Opioids:

Frequency not reported: Adrenal insufficiency, androgen deficiency

References

1. “Product Information. Fioricet with Codeine (acetaminophen / butalbital / caffeine / codeine).” Watson Pharmaceuticals, Parsippany, NJ.

2. “Product Information. APAP/Butalbital/Caffeine/Codeine (acetaminophen / butalbital / caffeine / codeine).” West-Ward Pharmaceutical Corporation, Eatontown, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.