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

Serious side effects

Along with its needed effects, acetaminophen/butalbital/caffeine 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 / caffeine:

More common

• Lightheadedness
• shortness of breath

Incidence not known

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• change in the frequency of urination or amount of urine
• chills
• cough
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• dizziness
• drowsiness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed or dry skin
• fruit-like breath odor
• hives, itching, or skin rash
• increased hunger
• increased thirst
• increased urination
• joint or muscle pain
• loss of appetite
• nausea or vomiting
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness

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

Symptoms of overdose

• Confusion as to time, place, or person
• dark urine
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• general feeling of discomfort or illness
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased sweating
• irregular, fast or slow, or shallow breathing
• light-colored stools
• loss of appetite
• pale or blue lips, fingernails, or skin
• restlessness
• sudden decrease in the amount of urine
• sweating
• trouble sleeping
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• vomiting of blood
• yellow eyes or skin

Other side effects

Some side effects of acetaminophen / butalbital / caffeine 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:

More common

• Relaxed and calm
• sleepiness

Incidence not known

• Anxiety
• bloated
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• depression
• earache
• excess air or gas in the stomach or intestines
• false or unusual sense of well-being
• full feeling
• hearing loss
• heartburn
• heavy eyelids
• high energy
• hot spells
• hyperventilation
• irritability
• numbness
• pain in the leg
• passing gas
• sluggishness
• stuffy nose
• tingling sensation

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

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]

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

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

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]

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]