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Albenza Side Effects, and Drug Interactions - Albendazole
SIDE EFFECTS
The adverse event profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of ≥1% in either disease are described in the table below.
These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects events that were reported by investigators to be at least possibly or probably related to albendazole.
|
Adverse
Event |
Hydatid Disease | Neurocysticercosis |
|
Abnormal Liver
Function Tests |
15.6 | <1.0 |
|
Abdominal Pain
|
6.0 | 0 |
|
Nausea/Vomiting
|
3.7 | 6.2 |
|
Headache
|
1.3 | 11.0 |
|
Dizziness/Vertigo
|
1.2 | <1.0 |
|
Raised Intracranial Pressure
|
0 | 1.5 |
|
Meningeal Signs
|
0 | 1.0 |
|
Reversible Alopecia
|
1.6 | <1.0 |
|
Fever
|
1.0 | 0 |
The following adverse events were observed at an incidence of <1%:
Hematologic: Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia. (See WARNINGS .)
Dermatologic: Rash, urticaria.
Hypersensitivity: Allergic reactions.
Renal: Acute renal failure related to albendazole therapy has been observed.
Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was coadministered with each dose of albendazole (15 mg/kg/day) in eight neurocysticercosis patients.
Praziquantel: In the fed state, praziquantel (40 mg/kg) increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects (n=10) compared with a separate group of subjects (n=6) given albendazole alone. Mean T max and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following coadministration with albendazole (400 mg).
Cimetidine: Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n=7) compared with albendazole (20 mg/kg/day) alone (n=12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.
Theophylline: The pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged following a single oral dose of albendazole (400 mg) in 6 healthy subjects.
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