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ALBENDAZOLE
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- 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.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
1
42911
Other ADRs
713
14116566
Odds Ratio = 0.462
Drug Property Information
ATC Code(s):
- P02CA03 - albendazole
- P02CA - Benzimidazole derivatives
- P02C - ANTINEMATODAL AGENTS
- P02 - ANTHELMINTICS
- P - "ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS"
Active Ingredient:albendazole
Active Ingredient UNII:F4216019LN
Drugbank ID:DB00518
PubChem Compound:2082
CAS Number:54965-21-8
Dosage Form(s):tablet, chewable; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 400.0 mg/day P02CA03
Chemical Structure: 
SMILE Code:
CCCSC1=CC2=C(C=C1)N=C(N2)NC(=O)OC
CCCSC1=CC2=C(C=C1)N=C(N2)NC(=O)OC
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: [Hydatid disease of the femoral shaft treated with surgery and hypertonic solution wash-out combined with albendazole].
[Winter M,Jacquot N,Balaguer T,de Peretti F]Rev Chir Orthop Reparatrice Appar Mot.2005 Oct;91(6):564-8. PMID: 16327693
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