Skip to Content

Acetaminophen / butalbital Side Effects

For the Consumer

Applies to acetaminophen / butalbital: oral capsule, oral tablet

Warning

  • This drug has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • Shortness of breath.
  • Slurred speech, stumbling, or feeling confused, very sleepy or dizzy, or drunk.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling sleepy.
  • Stomach pain.
  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to acetaminophen / butalbital: oral capsule, oral tablet

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

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]

Acetaminophen:

Frequency not reported: Liver failure[Ref]

Hypersensitivity

Butalbital-Acetaminophen:

Uncommon (0.1% to 1%): Allergic reactions

Postmarketing reports: Anaphylaxis

Acetaminophen:

Postmarketing reports: Anaphylaxis[Ref]

Dermatologic

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

Butalbital-Acetaminophen:

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]

Psychiatric

Uncommon (0.1% to 1%): Agitation, euphoria[Ref]

Nervous system

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[Ref]

Respiratory

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

Uncommon (0.1% to 1%): Nasal congestion[Ref]

Gastrointestinal

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

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

Hematologic

Acetaminophen:

Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia[Ref]

Musculoskeletal

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

Renal

Uncommon (0.1% to 1%): Diuresis,[Ref]

References

1. "Product Information. Allzital (acetaminophen-butalbital)." Skylar Laboratories, Canton, MS.

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.