Note: This document contains side effect information about acetaminophen / butalbital. Some dosage forms listed on this page may not apply to the brand name Allzital.
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 Allzital
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
- Dizziness
- lightheadedness
- sleepiness
- trouble breathing
Less common
- Anxiety
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chest tightness
- chills
- cough or hoarseness
- diarrhea
- difficulty swallowing
- discouragement
- dry mouth
- excitement
- fainting
- false or unusual sense of well-being
- fast, pounding, or irregular heartbeat or pulse
- feeling sad or empty
- headache
- heavy eyelids
- high energy
- hives, itching, skin rash
- hot spells
- hyperventilation
- irregular heartbeats
- irritability
- joint or muscle pain
- lack of appetite
- loss of interest or pleasure
- lower back or side pain
- mental confusion
- nervousness
- painful or difficult urination
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- red irritated eyes
- red skin lesions, often with a purple center
- restlessness
- seizures
- shaky feeling
- sluggishness
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- trouble concentrating
- trouble sleeping
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Dark urine
- loss of appetite
- nausea or vomiting
- stomach pain, severe
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / butalbital:
Symptoms of overdose
- Black, tarry stools
- bloody or cloudy urine
- blurred vision
- change in consciousness
- chills
- confusion
- dark urine
- difficult or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- headache
- irregular, fast or slow, or shallow breathing
- itching
- light-colored stools
- loss of appetite
- loss of consciousness
- nausea
- pale or blue lips, fingernails, or skin
- sleepiness
- stomach pain
- sudden decrease in amount of urine
- sweating
- trouble breathing
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Other side effects of Allzital
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
- Bloated
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- dry mouth
- earache
- excess air or gas in the stomach or intestines
- full feeling
- hearing loss
- heartburn
- increased sweating
- indigestion
- leg pain
- passing gas
- stuffy nose
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]
