A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pepcid Side Effects, and Drug Interactions - Famotidine (oral)
Pepcid Side Effects, and Drug Interactions - Famotidine (oral)
SIDE EFFECTS
The adverse reactions listed below have been reported during domestic
and international clinical
trials in approximately 2500 patients. In
those controlled clinical
trials in which PEPCID Tablets were compared to placebo, the incidence
of adverse experiences in the group
which received PEPCID Tablets, 40 mg
at bedtime, was similar to that in the placebo
group.
The following adverse reactions have been reported to occur in
more than 1% of patients on therapy
with PEPCID in controlled clinical
trials, and may be causally related to the drug: headache
(4.7%), dizziness
(1.3%), constipation (1.2%) and diarrhea
(1.7%).
The following other adverse reactions have been reported infrequently
in clinical trials
or since the drug was marketed.
The relationship to therapy with PEPCID has been unclear in many
cases. Within each category the adverse reactions are listed in
order of decreasing severity:
Body as a Whole: fever,
asthenia, fatigue
Cardiovascular: arrhythmia,
AV block, palpitation
Gastrointestinal: cholestatic jaundice,
liver enzyme
abnormalities, vomiting, nausea,
abdominal discomfort,
anorexia, dry mouth
Hematologic: rare cases of agranulocytosis,
pancytopenia, leukopenia, thrombocytopenia
Hypersensitivity: anaphylaxis, angioedema,
orbital or facial edema,
urticaria, rash,
conjunctival injection
Musculoskeletal: musculoskeletal pain
including muscle cramps, arthralgia
Nervous System/Psychiatric: grand mal
seizure; psychic disturbances, which were reversible
in cases for which follow-up
was obtained, including hallucinations, confusion,
agitation, depression,
anxiety, decreased libido;
paresthesia; insomnia; somnolence
Respiratory: bronchospasm
Skin: toxic
epidermal necrolysis
(very rare), alopecia, acne, pruritus,
dry skin, flushing
Special Senses: tinnitus,
taste disorder
Other: rare cases of impotence
and rare cases of gynecomastia have been reported; however, in controlled
clinical trials, the
incidences were not greater than those seen with placebo.
The adverse reactions reported for PEPCID Tablets may also occur
with PEPCID for Oral Suspension and PEPCID RPD Orally Disintegrating
Tablets.
DRUG INTERACTIONS
No drug interactions have
been identified. Studies with famotidine
in man, in animal models,
and in vitro have shown no
significant interference
with the disposition
of compounds metabolized by the hepatic
microsomal enzymes, e.g., cytochrome
P450 system. Compounds tested in man
include warfarin, theophylline, phenytoin, diazepam, aminopyrine
and antipyrine. Indocyanine green
as an index of hepatic
drug extraction
has been tested and no significant
effects have been found.
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