ADVERSE REACTIONS
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 Incidence ≥1% in Hydatid Disease and Neurocysticercosis |
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%:
Blood and Lymphatic System Disorders
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
Hypersensitivity reactions, including rash and urticaria.
Postmarketing Adverse Reactions
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
Aplastic anemia, bone marrow suppression, neutropenia.
Hepatobiliary Disorders
Elevations of hepatic enzymes, hepatitis, acute liver failure.
Skin and Subcutaneous Tissue Disorders
Erythema multiforme, Stevens-Johnson syndrome.
Renal and Urinary Disorders
Acute renal failure.
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