ALBENDAZOLE

N/A

Manufactured by Amneal Pharmaceuticals LLC

9,857 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ALBENDAZOLE

ALBENDAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for ALBENDAZOLE include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, PRODUCT USE IN UNAPPROVED INDICATION, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALBENDAZOLE.

Top Adverse Reactions

DRUG INEFFECTIVE365 reports
OFF LABEL USE284 reports
PYREXIA236 reports
PRODUCT USE IN UNAPPROVED INDICATION224 reports
HEADACHE221 reports
CONDITION AGGRAVATED212 reports
FATIGUE166 reports
WEIGHT DECREASED166 reports
RASH165 reports
PAIN164 reports
SOMNOLENCE159 reports
HAEMATOCHEZIA157 reports
RECTAL HAEMORRHAGE149 reports
COLITIS ULCERATIVE148 reports
STRESS148 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION147 reports
INTENTIONAL PRODUCT USE ISSUE147 reports
STEROID DEPENDENCE147 reports
BRONCHIECTASIS146 reports
DEEP VEIN THROMBOSIS146 reports
FREQUENT BOWEL MOVEMENTS146 reports
MEDICATION ERROR144 reports
ABDOMINAL DISCOMFORT142 reports
VERTIGO142 reports
CONFUSIONAL STATE141 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES140 reports
PALPITATIONS140 reports
DEPRESSION136 reports
PAIN IN EXTREMITY136 reports
IMPAIRED WORK ABILITY134 reports
COVID 19131 reports
CEREBROVASCULAR ACCIDENT130 reports
ARTHRITIS129 reports
TINNITUS129 reports
DYSGEUSIA128 reports
RHINITIS128 reports
CARDIAC MURMUR127 reports
ECZEMA127 reports
MIGRAINE127 reports
SYSTEMIC LUPUS ERYTHEMATOSUS127 reports
BURNS SECOND DEGREE126 reports
GINGIVAL PAIN126 reports
HYPOPNOEA126 reports
NIGHTMARE126 reports
PULMONARY EMBOLISM126 reports
ACCIDENTAL OVERDOSE125 reports
ADVERSE DRUG REACTION125 reports
SWOLLEN TONGUE125 reports
TUBULOINTERSTITIAL NEPHRITIS125 reports
CATARRH124 reports
VOMITING124 reports
PAROSMIA123 reports
IMPAIRED QUALITY OF LIFE122 reports
ASTHENIA89 reports
DIARRHOEA87 reports
ALCOHOL POISONING73 reports
NAUSEA73 reports
STRONGYLOIDIASIS73 reports
DEATH64 reports
DIZZINESS62 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION62 reports
PRURITUS61 reports
ABDOMINAL PAIN52 reports
SEPTIC SHOCK51 reports
DECREASED APPETITE46 reports
EXPOSURE DURING PREGNANCY43 reports
ANAEMIA42 reports
NEUTROPENIA41 reports
SEPSIS40 reports
TOXICITY TO VARIOUS AGENTS40 reports
ALOPECIA39 reports
DEHYDRATION38 reports
DRUG INTERACTION36 reports
ACUTE KIDNEY INJURY35 reports
PNEUMONIA34 reports
PANCYTOPENIA33 reports
ABDOMINAL PAIN UPPER32 reports
DYSPNOEA30 reports
GAIT DISTURBANCE30 reports
GASTRITIS30 reports
RESPIRATORY FAILURE30 reports
TRANSAMINASES INCREASED30 reports
LOSS OF CONSCIOUSNESS29 reports
SEIZURE29 reports
THERAPY NON RESPONDER29 reports
ABORTION SPONTANEOUS27 reports
COMA27 reports
ENCEPHALOPATHY27 reports
RENAL IMPAIRMENT27 reports
VISION BLURRED27 reports
STEVENS JOHNSON SYNDROME26 reports
ARTHRALGIA25 reports
TREATMENT FAILURE25 reports
ASTHMA24 reports
BLOOD BILIRUBIN INCREASED24 reports
MYALGIA24 reports
ENCEPHALITIS23 reports
TOXIC EPIDERMAL NECROLYSIS22 reports
HELMINTHIC INFECTION21 reports
OEDEMA PERIPHERAL21 reports

Report Outcomes

Out of 1,828 classified reports for ALBENDAZOLE:

Serious 85.8%Non-Serious 14.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male859 (53.0%)
Female758 (46.8%)
Unknown4 (0.2%)

Reports by Age

Age 5399 reports
Age 5137 reports
Age 6136 reports
Age 5835 reports
Age 3534 reports
Age 6431 reports
Age 7031 reports
Age 6030 reports
Age 4629 reports
Age 4327 reports
Age 2425 reports
Age 2525 reports
Age 3825 reports
Age 1724 reports
Age 1923 reports
Age 2723 reports
Age 5723 reports
Age 6323 reports
Age 522 reports
Age 4222 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ALBENDAZOLE?

This profile reflects 9,857 FDA FAERS reports that mention ALBENDAZOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALBENDAZOLE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, PRODUCT USE IN UNAPPROVED INDICATION, HEADACHE, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALBENDAZOLE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with ALBENDAZOLE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.