Albenza Side Effects

Generic Name: albendazole

Please note - some side effects for Albenza may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Albenza - for the Consumer

Albenza

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Albenza:

Headache; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Albenza:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased urination; fever, chills, or sore throat; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or headache; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Albenza Side Effects - for the Professional

Albenza

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. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression.

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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Side Effects by Body System - for Healthcare Professionals

General

The side effects of albendazole differ between hydatid disease and neurocysticercosis. The symptoms were generally mild and resolved without treatment. Treatment was discontinued primarily due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease).

Dermatologic

Dermatologic side effects have included reversible alopecia (1.6% in hydatid disease; less than 1% in neurocysticercosis). Erythema multiforme and Stevens-Johnson syndrome have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions (including rash and urticaria) in less than 1% of patients.

Renal

Renal side effects have included acute renal failure during postmarketing experience.

Hepatic

Hepatic side effects have included abnormal liver function tests (15.6% in hydatid disease; less than 1% in neurocysticercosis) and hepatotoxicity (greater than or equal to 1%). Hepatic abnormalities, acute liver failure, elevations of hepatic enzymes, and hepatitis have been reported during postmarketing experience.

Hematologic

Hematologic side effects have rarely included granulocytopenia, agranulocytosis, pancytopenia, and thrombocytopenia. Leukopenia has been reported in less than 1% of patients. Aplastic anemia, bone marrow suppression, and neutropenia have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (6% in hydatid disease), nausea/vomiting (3.7% in hydatid disease; 6.2% in neurocysticercosis).

Nervous system

Nervous system side effects have included headache (1.3% in hydatid disease; 11% in neurocysticercosis), dizziness/vertigo (1.2% in hydatid disease; less than 1% in neurocysticercosis), raised intracranial pressure (1.5% in neurocysticercosis), meningeal signs (1% in neurocysticercosis).

Other

Other side effects have included fever (1% in hydatid disease).

Ocular

Ocular side effects have included retinal damage.

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