ADVERSE REACTIONS
Frequently Observed
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
Infrequently Observed
All adverse events tabulated below are classified as infrequent.
Central Nervous:
headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.
Autonomic Nervous:
dry mouth, hyperhidrosis.
Gastrointestinal:
difficulty swallowing, heartburn, flatulence, constipation.
Cardiovascular:
tachycardia.
Musculoskeletal:
leg pain, muscle fatigue.
Genitourinary:
diuresis.
Miscellaneous:
pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
The following adverse reactions have been voluntarily reported as temporally associated with Fiorinal® with Codeine, a related product containing aspirin, butalbital, caffeine, and codeine.
Central Nervous:
abuse, addiction, anxiety, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.
Autonomic Nervous:
epistaxis, flushing, miosis, salivation.
Gastrointestinal:
anorexia, appetite increased, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasms, hiccup, mouth burning, pyloric ulcer.
Cardiovascular:
chest pain, hypotensive reaction, palpitations, syncope.
Skin:
erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.
Urinary:
kidney impairment, urinary difficulty.
Miscellaneous:
allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.
The following adverse drug events may be borne in mind as potential effects of the components of Fioricet with Codeine. Potential effects of high dosage are listed in the
OVERDOSAGE
section.
Acetaminophen:
allergic reactions, rash, thrombocytopenia, agranulocytosis.
Caffeine:
cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.
Codeine:
nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets, USP).
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