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
Amaryl Side Effects, and Drug Interactions - Glimepiride
Amaryl Side Effects, and Drug Interactions - Glimepiride
SIDE EFFECTS
The incidence of
hypoglycemia with
glimepiride, as documented by blood glucose values <60 mg/dl,
ranged from 0.9% to 1.7% in two large, well-controlled, 1-year studies.
(See WARNINGS and PRECAUTIONS.)
Glimepiride has been evaluated for safety in 2013 patients in US
controlled trials, and in 1551 patients in foreign controlled trials.
More than 1650 of these patients were treated for at least 1 year.
Adverse events, other than hypoglycemia, considered to be possibly
or probably related to study drug
that occurred in US placebo-controlled trials in more than 1% of
patients treated with glimepiride are shown in TABLE 2.
| TABLE 2 Adverse Events Occurring
in ³1% Glimepiride Patients |
| |
Glimepiride |
Placebo |
| |
No. |
% |
No. |
% |
| Total Treated |
746 |
100 |
294 |
100 |
| Dizziness |
13 |
1.7 |
1 |
0.3 |
| Asthenia |
12 |
1.6 |
3 |
1.0 |
| Headache |
11 |
1.5 |
4 |
1.4 |
| Nausea |
8 |
1.1 |
|
0.0 |
Gastrointestinal Reactions: Vomiting, gastrointestinal
pain, and diarrhea
have been reported, but the incidence
in placebo-controlled trials was less than 1%. In rare cases, there may be an elevation of liver enzyme levels. In isolated instances, impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may also lead to liver failure have been reported with sulfonylureas, including AMARYL .
Dermatologic Reactions: Allergic skin
reactions, e.g., pruritus, erythema, urticaria, and morbilliform
or maculopapular
eruptions, occur in less than 1% of treated patients. These may
be transient and may
disappear despite continued use of glimepiride; if skin
reactions persist, the drug
should be discontinued. Porphyria cutanea tarda and photosensitivity
reactions have been reported with sulfonylureas.
Hematologic Reactions: Leukopenia, agranulocytosis,
thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia
have been reported with sulfonylureas.
Metabolic Reactions: Hepatic porphyria
reactions and disulfiram-like reactions have been reported with
sulfonylureas; however, no cases have yet been reported with glimepiride
tablets. Cases of hyponatremia
have been reported with glimepiride and all other sulfonylureas,
most often in patients who are on other medications or have medical
conditions known to cause
hyponatremia or
increase release of
antidiuretic hormone.
The syndrome of inappropriate antidiuretic
hormone (SIADH) secretion
has been reported with certain other sulfonylureas, and it has been
suggested that these sulfonylureas may augment the peripheral
(antidiuretic) action
of ADH and/or increase release
of ADH.
Other Reactions: Changes in accommodation
and/or blurred vision may occur with the use of glimepiride. This
is thought to be due to changes in blood
glucose, and may be more pronounced when treatment is initiated.
This condition is
also seen in untreated diabetic
patients, and may actually be reduced by treatment. In
placebo-controlled trials of glimepiride, the incidence
of blurred vision was
placebo, 0.7%, and glimepiride, 0.4%.
DRUG INTERACTIONS
See CLINICAL PHARMACOLOGY,
Drug Interactions.
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