openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Rare fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia (see PRECAUTIONS). Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with and without underlying hepatic dysfunction. Blood counts should be monitored at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Patients should not become pregnant for at least 1 month following cessation of albendazole therapy. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
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.