ACETAZOLAMIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

9,944 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAZOLAMIDE

ACETAZOLAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for ACETAZOLAMIDE include OFF LABEL USE, DRUG INEFFECTIVE, HEADACHE, CONDITION AGGRAVATED, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAZOLAMIDE.

Top Adverse Reactions

OFF LABEL USE665 reports
DRUG INEFFECTIVE643 reports
HEADACHE270 reports
CONDITION AGGRAVATED264 reports
FATIGUE244 reports
DYSPNOEA235 reports
NAUSEA227 reports
METABOLIC ACIDOSIS193 reports
PRODUCT USE IN UNAPPROVED INDICATION190 reports
DIARRHOEA160 reports
VOMITING152 reports
DIZZINESS149 reports
INTRAOCULAR PRESSURE INCREASED149 reports
PAIN147 reports
SOMNOLENCE141 reports
ACUTE KIDNEY INJURY136 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION130 reports
HYPOKALAEMIA117 reports
DEATH116 reports
FALL115 reports
PARAESTHESIA114 reports
ANXIETY113 reports
VISUAL IMPAIRMENT111 reports
DRUG INTERACTION110 reports
ASTHENIA109 reports
ARTHRALGIA108 reports
VISION BLURRED107 reports
HYPOTENSION104 reports
PYREXIA103 reports
TOXICITY TO VARIOUS AGENTS99 reports
CONFUSIONAL STATE97 reports
RASH95 reports
PAIN IN EXTREMITY91 reports
WEIGHT DECREASED91 reports
DEPRESSION89 reports
PNEUMONIA89 reports
SEIZURE84 reports
BACK PAIN83 reports
FOETAL EXPOSURE DURING PREGNANCY83 reports
MALAISE83 reports
GLAUCOMA82 reports
DECREASED APPETITE81 reports
RENAL FAILURE81 reports
URINARY TRACT INFECTION81 reports
INTRACRANIAL PRESSURE INCREASED79 reports
RESPIRATORY FAILURE76 reports
LUNG DISORDER72 reports
DEHYDRATION71 reports
EYE PAIN71 reports
WEIGHT INCREASED71 reports
ANGLE CLOSURE GLAUCOMA70 reports
THERAPY NON RESPONDER69 reports
DRUG HYPERSENSITIVITY67 reports
CHRONIC KIDNEY DISEASE66 reports
CHEST PAIN65 reports
DRUG INTOLERANCE65 reports
INSOMNIA65 reports
PAPILLOEDEMA64 reports
PRODUCT DOSE OMISSION ISSUE64 reports
GAIT DISTURBANCE63 reports
TREATMENT FAILURE63 reports
COUGH62 reports
FEELING ABNORMAL62 reports
ABDOMINAL PAIN UPPER61 reports
COVID 1961 reports
MIGRAINE61 reports
ABDOMINAL DISCOMFORT60 reports
ANAEMIA60 reports
CHOROIDAL EFFUSION60 reports
IDIOPATHIC INTRACRANIAL HYPERTENSION60 reports
RENAL IMPAIRMENT60 reports
CONSTIPATION59 reports
HYPOXIA59 reports
PRODUCT USE ISSUE59 reports
DISEASE PROGRESSION58 reports
VISUAL ACUITY REDUCED57 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS56 reports
CHOROIDAL DETACHMENT54 reports
LOSS OF CONSCIOUSNESS54 reports
HYPERTENSION53 reports
INFECTION53 reports
CATARACT52 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE52 reports
BLOOD PRESSURE INCREASED51 reports
HYPOAESTHESIA51 reports
PRURITUS51 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE51 reports
ABDOMINAL PAIN50 reports
ASTHMA50 reports
BLINDNESS48 reports
BALANCE DISORDER46 reports
ACUTE RESPIRATORY FAILURE44 reports
CARDIAC FAILURE CONGESTIVE44 reports
THROMBOSIS44 reports
ATRIAL FIBRILLATION43 reports
NASOPHARYNGITIS43 reports
HAIR FOLLICLE TUMOUR BENIGN41 reports
MUSCULAR WEAKNESS41 reports
PULMONARY EMBOLISM41 reports
HEART RATE INCREASED40 reports

Report Outcomes

Out of 5,628 classified reports for ACETAZOLAMIDE:

Serious 80.6%Non-Serious 19.4%

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

Female3,190 (63.5%)
Male1,822 (36.3%)
Unknown12 (0.2%)

Reports by Age

Age 6797 reports
Age 6591 reports
Age 1586 reports
Age 3286 reports
Age 6186 reports
Age 5884 reports
Age 7082 reports
Age 3979 reports
Age 2771 reports
Age 5969 reports
Age 7268 reports
Age 4066 reports
Age 6066 reports
Age 8066 reports
Age 4263 reports
Age 6463 reports
Age 6962 reports
Age 3459 reports
Age 5159 reports
Age 5259 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 ACETAZOLAMIDE?

This profile reflects 9,944 FDA FAERS reports that mention ACETAZOLAMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAZOLAMIDE?

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

Who manufactures ACETAZOLAMIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with ACETAZOLAMIDE. 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.