ZINC OXIDE

N/A

Manufactured by MONAT GLOBAL CORP

9,433 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ZINC OXIDE

ZINC OXIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by MONAT GLOBAL CORP. The most commonly reported adverse reactions for ZINC OXIDE include DRUG INEFFECTIVE, MACULAR DEGENERATION, PYREXIA, OFF LABEL USE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZINC OXIDE.

Top Adverse Reactions

DRUG INEFFECTIVE510 reports
MACULAR DEGENERATION451 reports
PYREXIA304 reports
OFF LABEL USE298 reports
PAIN288 reports
NAUSEA281 reports
MALAISE261 reports
WEIGHT DECREASED240 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE214 reports
HEADACHE200 reports
INFUSION RELATED REACTION200 reports
CHRONIC SINUSITIS197 reports
PARAESTHESIA ORAL197 reports
DYSPEPSIA196 reports
CONSTIPATION192 reports
ABDOMINAL PAIN189 reports
PROCEDURAL PAIN189 reports
ANAEMIA187 reports
ERYTHEMA170 reports
DIARRHOEA166 reports
RECTAL HAEMORRHAGE163 reports
HAEMATOCHEZIA158 reports
FEMALE GENITAL TRACT FISTULA157 reports
RADICULOPATHY152 reports
FREQUENT BOWEL MOVEMENTS151 reports
COLITIS150 reports
COLITIS ULCERATIVE150 reports
ORAL CANDIDIASIS146 reports
VAGINAL DISCHARGE146 reports
VAGINAL FLATULENCE146 reports
PROCTITIS145 reports
VOMITING116 reports
PNEUMONIA91 reports
FATIGUE89 reports
BACK PAIN86 reports
ASTHENIA81 reports
RASH78 reports
FEBRILE NEUTROPENIA75 reports
ARTHRALGIA67 reports
NEUTROPENIA64 reports
DYSPNOEA63 reports
FALL63 reports
CONDITION AGGRAVATED58 reports
PROCTALGIA56 reports
GAIT DISTURBANCE53 reports
HYPERTENSION53 reports
PRURITUS51 reports
CHILLS48 reports
URINARY TRACT INFECTION48 reports
SEPSIS46 reports
HEPATIC ENZYME INCREASED45 reports
HAEMORRHOIDS42 reports
DEATH41 reports
DIZZINESS41 reports
RENAL FAILURE41 reports
ACUTE KIDNEY INJURY40 reports
BODY TEMPERATURE INCREASED39 reports
CROHN^S DISEASE39 reports
DECREASED APPETITE39 reports
COUGH38 reports
HYPOTENSION38 reports
ANAL INFLAMMATION37 reports
ACCIDENT36 reports
CHOLELITHIASIS36 reports
OEDEMA PERIPHERAL35 reports
PAIN IN EXTREMITY35 reports
ARTHROPATHY34 reports
DIABETES MELLITUS33 reports
PSORIASIS33 reports
SARS COV 2 TEST NEGATIVE33 reports
ARTHRITIS31 reports
CHEST PAIN31 reports
PRODUCT DOSE OMISSION ISSUE31 reports
OSTEOARTHRITIS30 reports
MUSCULOSKELETAL STIFFNESS29 reports
THROMBOCYTOPENIA29 reports
COVID 1928 reports
LIMB INJURY28 reports
RESPIRATORY FAILURE28 reports
DEHYDRATION27 reports
INSOMNIA27 reports
MUSCULOSKELETAL PAIN27 reports
OSTEOPOROSIS27 reports
PSORIATIC ARTHROPATHY27 reports
SOMNOLENCE27 reports
DYSSTASIA26 reports
HYPERSENSITIVITY26 reports
SEIZURE26 reports
CHRONIC KIDNEY DISEASE25 reports
CONFUSIONAL STATE25 reports
HEPATIC STEATOSIS25 reports
MOVEMENT DISORDER25 reports
SCIATICA25 reports
GASTROOESOPHAGEAL REFLUX DISEASE24 reports
HAEMOGLOBIN DECREASED24 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION24 reports
INFECTION24 reports
JOINT STIFFNESS24 reports
LIVER DISORDER24 reports
PNEUMONIA ASPIRATION24 reports

Report Outcomes

Out of 1,946 classified reports for ZINC OXIDE:

Serious 83.9%Non-Serious 16.1%

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

Female1,125 (63.2%)
Male654 (36.7%)
Unknown1 (0.1%)

Reports by Age

Age 71133 reports
Age 6583 reports
Age 2041 reports
Age 7040 reports
Age 6934 reports
Age 7430 reports
Age 7329 reports
Age 8229 reports
Age 6827 reports
Age 6325 reports
Age 7724 reports
Age 5223 reports
Age 6423 reports
Age 6723 reports
Age 7823 reports
Age 6621 reports
Age 7921 reports
Age 8419 reports
Age 8018 reports
Age 5317 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 ZINC OXIDE?

This profile reflects 9,433 FDA FAERS reports that mention ZINC OXIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ZINC OXIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, MACULAR DEGENERATION, PYREXIA, OFF LABEL USE, PAIN, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ZINC OXIDE?

Labeling and FAERS entries often list MONAT GLOBAL CORP in connection with ZINC OXIDE. 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.