ALBENZA SIDE EFFECTS
- Generic Name: albendazole
- Brand Name: Albenza
- Drug Class: Anthelmintics
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction profile of ALBENZA differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 1 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 adverse reactions that were reported to be at least possibly or probably related to ALBENZA.
Table 1: Adverse Reaction Incidence 1% or Greater in Hydatid Disease and Neurocysticercosis
| Adverse Reaction | Hydatid Disease | Neurocysticercosis |
| Gastrointestinal | ||
| Abdominal Pain | 6 | 0 |
| Nausea | 4 | 6 |
| Vomiting | 4 | 6 |
| General disorders and administration site conditions | ||
| Fever | 1 | 0 |
| Investigations | ||
| Elevated Hepatic Enzymes | 16 | less than 1 |
| Nervous system disorders | ||
| Dizziness | 1 | less than 1 |
| Headache | 1 | 11 |
| Meningeal Signs | 0 | 1 |
| Raised Intracranial Pressure | 0 | 2 |
| Vertigo | 1 | less than 1 |
| Skin and subcutaneous tissue disorders | ||
| Reversible Alopecia | 2 | less than 1 |
The following adverse events were observed at an incidence of less than 1%:
Blood and Lymphatic System Disorders: There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia.
Immune System Disorders: Hypersensitivity reactions, including rash and urticaria.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ALBENZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.
Eye Disorders: Vision blurred.
Gastrointestinal Disorders: Diarrhea.
General System Disorders: Asthenia.
Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure.
Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.
Nervous System Disorders: Somnolence, convulsion.
Renal and Urinary Disorders: Acute renal failure.
Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome.
SRC: NLM .