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
Ergamisol Side Effects, and Drug Interactions - Levamisole Hydrochloride
Ergamisol Side Effects, and Drug Interactions - Levamisole Hydrochloride
SIDE EFFECTS
Almost all patients receiving ERGAMISOL® (levamisole hydrochloride)
and fluorouracil reported adverse experiences. Tabulated below is the
incidence of adverse experiences that occurred in at least 1% of patients
enrolled in two clinical trials who were adjuvantly treated with either
ERGAMISOL® or ERGAMISOL® plus fluorouracil
following colon surgery. In the larger clinical trial, 66 of 463 patients
(14%) discontinued the combination of ERGAMISOL® plus fluorouracil
because of adverse reactions. Forty-three of these patients (9%) developed
isolated or a combination of gastrointestinal toxicities (e.g. nausea,
vomiting, diarrhea, stomatitis and anorexia). Ten patients developed rash
and/or pruritus. Five patients discontinued therapy because of flu-like
symptoms or fever with chills; ten patients developed central nervous
system symptoms such as dizziness, ataxia, depression, confusion, memory
loss, weakness, inability to concentrate, and headache; two patients developed
reversible neutropenia and sepsis; one patient because of thrombocytopenia;
one patient because of hyperbilirubinemia. One patient in the ERGAMISOL®
plus fluorouracil group developed agranulocytosis and sepsis and died.
In the ERGAMISOL® alone arm of the trial, 15 of 310 patients
(4.8%) discontinued therapy because of adverse experiences. Six of these
(2%) discontinued because of rash, six because of arthralgia/myalgia,
and one each for fever and neutropenia, urinary infection, and cough.
|
Adverse experience
|
ERGAMISOL®
N = 440
% |
ERGAMISOL®
plus fluorouracil
N = 599
% |
| Gastrointestinal |
| Nausea |
22 |
65 |
| Diarrhea |
13 |
52 |
| Stomatitis |
3 |
39 |
| Vomiting |
6 |
20 |
| Anorexia |
2 |
6 |
| Abdominal pain |
2 |
5 |
| Constipation |
2 |
3 |
| Flatulence |
<1 |
2 |
| Dyspepsia |
<1 |
1 |
| Hematological |
| Leukopenia |
|
|
| < 2000/mm3 |
<1 |
1 |
| ³
2000 to < 4000/mm3 |
4 |
19 |
| ³
4000/mm3 |
2 |
33 |
| unscored category |
0 |
<1 |
| Thrombocytopenia |
|
|
| < 50,000/ mm3
|
0 |
0 |
| ³
50, 000 to < 130,000/mm3 |
1 |
8 |
| ³
130,000/mm3 |
1 |
10 |
| Anemia |
0 |
6 |
| Granulocytopenia |
<1 |
2 |
| Epistaxis |
0 |
1 |
| Skin and Appendages |
| Dermatitis |
8 |
23 |
| Alopecia |
3 |
22 |
| Pruritus |
1 |
2 |
| Skin discoloration |
0 |
2 |
| Urticaria |
<1 |
0 |
| Body as a Whole |
| Fatigue |
6 |
11 |
| Fever |
3 |
5 |
| Rigors |
3 |
5 |
| Chest pain |
<1 |
1 |
| Edema |
1 |
1 |
| Resistance Mechanisms |
| Infection |
5 |
12 |
| Special Senses |
| Taste Perversion |
8 |
8 |
| Altered sense of smell |
1 |
1 |
| Musculoskeletal System |
| Arthralgia |
5 |
4 |
| Myalgia |
3 |
2 |
| Central and peripheral nervous system |
| Dizziness |
3 |
4 |
| Headache |
3 |
4 |
| Paresthesia |
2 |
3 |
| Ataxia |
0 |
2 |
| Psychiatric |
| Somnolence |
3 |
2 |
| Depression |
1 |
2 |
| Nervousness |
1 |
2 |
| Insomnia |
1 |
1 |
| Anxiety |
1 |
1 |
| Forgetfulness |
0 |
1 |
| Vision |
| Abnormal tearing |
0 |
4 |
| Blurred vision |
1 |
2 |
| Conjunctivitis |
<1 |
2 |
| Liver and biliary system |
| Hyperbilirubinemia |
<1 |
1 |
In worldwide experience with ERGAMISOL®, less frequent
adverse experiences included exfoliative dermatitis, fixed drug eruptions,
periorbital edema, vaginal bleeding, anaphylaxis, confusion, convulsions,
hallucinations, impaired concentration, renal failure, pancreatitis, elevated
serum creatinine, and increased alkaline phosphatase.
Reports of hyperlipidemia have been observed in patients receiving combination
therapy of ERGAMISOL® and fluorouracil; elevations in triglyceride
levels have been greater than increases in cholesterol levels. In worldwide
postmarketing experience with the combination therapy, there have been
rare cases of elevated hepatic enzymes and hepatosteatosis in patients.
The following additional adverse experiences have been reported for fluorouracil
alone: esophagopharyngitis, pancytopenia, myocardial ischemia, angina,
gastrointestinal ulceration and bleeding, anaphylaxis and generalized
allergic reactions, acute cerebellar syndrome, nystagmus, dry skin, fissuring,
photosensitivity, lacrimal duct stenosis, photophobia, euphoria, thrombophlebitis,
and nail changes.
DRUG INTERACTIONS
ERGAMISOL® (levamisole hydrochloride) has been reported
to produce "ANTABUSE"-like side effects when given concomitantly with
alcohol. Concomitant administration of phenytoin and ERGAMISOL®
plus fluorouracil has lead to increased plasma levels of phenytoin. The
physician is advised to monitor plasma levels of phenytoin and to decrease
the dose if necessary.
Because of reports of prolongation of the prothrombin time beyond the
therapeutic range in patients taking concurrent levamisole and warfarin
sodium, it is suggested that the prothrombin time be monitored carefully,
and the dose of warfarin sodium or other coumarin-like drugs should be
adjusted accordingly, in patients taking both drugs.
top
