The most frequently reported adverse reactions are
drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea,
vomiting, abdominal pain, and intoxicated feeling.
All adverse events tabulated below are classified as
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.
Musculoskeletal: leg pain, muscle fatigue.
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 phosphate.
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,
Gastrointestinal: anorexia, appetite increased,
diarrhea, esophagitis, gastroenteritis, gastrointestinal spasms, hiccup, mouth
burning, pyloric ulcer.
Cardiovascular: chest pain, hypotensive reaction, palpitations,
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),
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,
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
Butalbital, Acetaminophen, and Caffeine Tablets, USP.
Drug Abuse And Dependence
Fioricet with Codeine is controlled by the Drug
Enforcement Administration and is classified under Schedule III.
Abuse And Dependence
Barbiturates may be habit-forming: Tolerance,
psychological dependence, and physical dependence may occur especially
following prolonged use of high doses of barbiturates. The average daily dose
for the barbiturate addict is usually about 1,500 mg. As tolerance to
barbiturates develops, the amount needed to maintain the same level of
intoxication increases; tolerance to a fatal dosage, however, does not increase
more than twofold. As this occurs, the margin between an intoxication dosage
and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less
if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium)
may occur within 16 hours and last up to 5 days after abrupt cessation of these
drugs. Intensity of withdrawal symptoms gradually declines over a period of
approximately 15 days. Treatment of barbiturate dependence consists of cautious
and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn
by using a number of different withdrawal regimens. One method involves
initiating treatment at the patient's regular dosage level and gradually
decreasing the daily dosage as tolerated by the patient.
Codeine can produce drug dependence of the morphine type
and, therefore, has the potential for being abused. Psychological dependence,
physical dependence, and tolerance may develop upon repeated administration and
it should be prescribed and administered with the same degree of caution
appropriate to the use of other oral narcotic medications.
The CNS effects of butalbital may be enhanced by
monoamine oxidase (MAO) inhibitors.
Fioricet with Codeine may enhance the effects of:
- Other narcotic analgesics, alcohol, general anesthetics,
tranquilizers such as chlordiazepoxide, sedative hypnotics, or other CNS
depressants, causing increased CNS depression.
Drug/Laboratory Test Interactions
Acetaminophen may produce false positive test results for
urinary 5hydroxyindoleacetic acid.
Codeine may increase serum amylase levels.