Promacet Side Effects
Generic Name: acetaminophen / butalbital
Note: This document contains side effect information about acetaminophen / butalbital. Some of the dosage forms listed on this page may not apply to the brand name Promacet.
For the Consumer
Applies to acetaminophen / butalbital: oral tablet
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.
- Change in balance.
- Feeling confused.
- Feeling very tired or weak.
- Very bad dizziness or passing out.
- Mood changes.
- A burning, numbness, or tingling feeling that is not normal.
- Shortness of breath.
- Any unexplained bruising or bleeding.
- 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:
- Feeling sleepy.
- Belly 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to acetaminophen/butalbital: oral capsule, oral tablet
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]
Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis
Postmarketing reports: Anaphylaxis[Ref]
Frequency not reported: Toxic epidermal necrolysis, erythema multiforme
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]
Uncommon (0.1% to 1%): Agitation, euphoria[Ref]
Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
Common (1% to 10%): Shortness of breath
Common (1% to 10%): Nausea, vomiting, abdominal pain
Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Diuresis,[Ref]
1. "Product Information. Allzital (acetaminophen-butalbital)." Skylar Laboratories, Canton, MS.
Some side effects may not be reported. You may report them to the FDA.
More about Promacet (acetaminophen / butalbital)
- Promacet Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- 0 Reviews
- Drug class: analgesic combinations