Albendazole adverse reactions

Albendazole

ALBENZA® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

## Adverse Reactions

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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.

The following adverse events were observed at an incidence of <1%:

#### Blood and Lymphatic System Disorders

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Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia (see WARNINGS). Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression (see WARNINGS and PRECAUTIONS).

#### Immune System Disorders

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Hypersensitivity reactions, including rash and urticaria.

#### Postmarketing Adverse Reactions

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In addition to adverse events reported from clinical trials, the following events have been identified during world-wide post-approval use of ALBENZA. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ALBENZA.

#### Blood and Lymphatic System Disorders

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Aplastic anemia, bone marrow suppression, neutropenia.

#### Hepatobiliary Disorders

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Elevations of hepatic enzymes, hepatitis, acute liver failure.

#### Skin and Subcutaneous Tissue Disorders

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Erythema multiforme, Stevens-Johnson syndrome.

#### Renal and Urinary Disorders

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Acute renal failure.[1]

## References

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1. ↑ "ALBENZA (ALBENDAZOLE) TABLET, FILM COATED [AMEDRA PHARMACEUTICALS LLC]".

Adapted from the FDA Package Insert.