Skip to main content

Sedapap Side Effects

Generic name: acetaminophen / butalbital

Medically reviewed by Drugs.com. Last updated on Oct 12, 2023.

Note: This document contains side effect information about acetaminophen / butalbital. Some dosage forms listed on this page may not apply to the brand name Sedapap.

Applies to acetaminophen / butalbital: oral capsule, oral tablet.

Warning

Oral route (Tablet; Capsule)

HepatotoxicityAcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

Serious side effects of Sedapap

Along with its needed effects, acetaminophen / butalbital 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:

More common

Less common

Incidence not known

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

Symptoms of overdose

Other side effects of Sedapap

Some side effects of acetaminophen / butalbital 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:

Less common

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. 2016.

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.