Acetaminophen, butalbital, and caffeine

Name: Acetaminophen, butalbital, and caffeine

What is acetaminophen, butalbital, and caffeine?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Acetaminophen, butalbital, and caffeine is a combination medicine used to treat tension headaches that are caused by muscle contractions.

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

What is the most important information I should know about acetaminophen, butalbital, and caffeine?

You should not use this medicine if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin 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.

What should I discuss with my healthcare provider before taking acetaminophen, butalbital, and caffeine?

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

To make sure acetaminophen, butalbital, and caffeine is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;

  • kidney disease;

  • asthma, sleep apnea, or other breathing disorder;

  • stomach ulcer or bleeding;

  • a history of skin rash caused by any medication;

  • a history of mental illness or suicidal thoughts; or

  • if you use medicine to prevent blood clots.

It is not known whether this medicine will harm an unborn baby. If you use butalbital 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 habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen, butalbital, and caffeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

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

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen, butalbital, and caffeine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

For Healthcare Professionals

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral liquid, oral tablet

Nervous system

Butalbital/Acetaminophen/Caffeine:
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[Ref]

General

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

Hepatic

Acetaminophen:
Frequency not reported: Liver failure[Ref]

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

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain
Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]

Renal

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Diuresis

Caffeine:
Frequency not reported: Nephrotoxicity[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis

Acetaminophen:
Postmarketing reports: Anaphylaxis[Ref]

Hematologic

Acetaminophen:
Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Dermatologic

Butalbital/Acetaminophen/Caffeine:
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[Ref]

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported.[Ref]

Respiratory

Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion[Ref]

Cardiovascular

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Tachycardia

Caffeine:
Frequency not reported: Cardiac stimulation[Ref]

Other

Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus[Ref]

Metabolic

Caffeine:
Frequency not reported: Hyperglycemia[Ref]

Musculoskeletal

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

Psychiatric

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Agitation, euphoria

Caffeine:
Frequency not reported: Irritability, dependence[Ref]

Some side effects of acetaminophen / butalbital / caffeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Dose Adjustments

Use with caution

How it works

  • Acetaminophen/butalbital/caffeine is a combination tablet containing three different ingredients: acetaminophen, butalbital, and caffeine.
  • Experts aren't sure exactly how acetaminophen works, but suspect it blocks a specific type of cyclo-oxygenase (COX) enzyme, located mainly in the brain.
  • Butalbital belongs to the class of medicines called barbiturates. When used for tension headaches it relaxes muscle contractions and causes sedation via an enhancement of the inhibitory effects of GABA (a neurotransmitter that regulates communication between brain cells).
  • Caffeine is thought to enhance the pain-relieving effects of acetaminophen by up to 40%. In addition, it has vasoconstrictive properties, narrowing blood vessels in the brain thereby decreasing blood flow and oxygen tension (before a headache or migraine, blood vessels tend to enlarge). This also helps to relieve pain.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Dizziness, drowsiness, lightheadedness, sedation, shortness of breath, nausea, vomiting, abdominal pain, or an intoxicated feeling are the most commonly reported side effects.
  • Other side effects, such as constipation, excessive sweating, itch, and mental confusion are uncommon.
  • Butalbital is habit-forming and there is a high risk of dependence with extended and repeated use of acetaminophen/butalbital/caffeine.
  • May cause medication-overuse headache with repeated use and a withdrawal syndrome on discontinuation.
  • The potential for liver damage with the acetaminophen component exists, even at recommended dosages. The risk is increased with higher dosages, with chronic alcohol use, with some medications, and in patients with significant liver disease.
  • May not be suitable for some people, including the elderly and people with kidney or liver disease.
  • Although acetaminophen/butalbital/caffeine may be prescribed for migraine headaches, it is not FDA approved for this use and evidence does not support its use for migraine.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Tips

  • Do not overuse acetaminophen/butalbital/caffeine because you may become addicted to it and have difficulty stopping it.
  • Over-use of acetaminophen/butalbital/caffeine can also result in medication-overuse headache (also known as a rebound headache) which occurs when analgesics are taken too frequently to relieve headache.
  • Never share your acetaminophen/butalbital/caffeine with anybody else.
  • May be administered without regards to food; although food may decrease any reported stomach upset.
  • If you have been taking acetaminophen/butalbital/caffeine regularly, or if you think you have become addicted to it, talk to your doctor about slowly withdrawing it, as sudden withdrawal may precipitate a withdrawal syndrome (symptoms include anxiety, dizziness, hallucinations, muscle twitching, nausea, seizures, sleeplessness, or tremor).
  • Acetaminophen/butalbital/caffeine can cause sedation and affect your ability to drive or operate machinery.
  • Do not drink more than two alcoholic drinks a day if you are a man or one alcoholic drink per day if you are women and taking acetaminophen/butalbital/caffeine.
  • Talk to your doctor or pharmacist before taking any other medications or natural products with acetaminophen/butalbital/caffeine as it can interact with a large number of drugs.
  • Talk to your doctor if you have any side effects of concern. Seek urgent medical advice if you develop an allergic-type reaction (difficulty breathing or swallowing, rash, or facial swelling) soon after taking acetaminophen/butalbital/caffeine.
  • Not recommended for women who are pregnant or breastfeeding.
(web3)