POVIDONE IODINE

N/A

Manufactured by Alcon Laboratories, Inc.

10,103 FDA adverse event reports analyzed

Last updated: 2026-04-15

About POVIDONE IODINE

POVIDONE IODINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alcon Laboratories, Inc.. The most commonly reported adverse reactions for POVIDONE IODINE include OFF LABEL USE, ENDOPHTHALMITIS, DRUG HYPERSENSITIVITY, TOXIC ANTERIOR SEGMENT SYNDROME, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POVIDONE IODINE.

Top Adverse Reactions

OFF LABEL USE438 reports
ENDOPHTHALMITIS415 reports
DRUG HYPERSENSITIVITY358 reports
TOXIC ANTERIOR SEGMENT SYNDROME281 reports
RASH234 reports
DRUG INEFFECTIVE219 reports
NAUSEA213 reports
PAIN197 reports
EYE PAIN196 reports
VISUAL ACUITY REDUCED165 reports
VISION BLURRED162 reports
HYPERSENSITIVITY150 reports
PRODUCT USE IN UNAPPROVED INDICATION141 reports
DYSPNOEA139 reports
VISUAL IMPAIRMENT135 reports
DIARRHOEA128 reports
VOMITING126 reports
HEADACHE124 reports
PRURITUS120 reports
PYREXIA119 reports
SWELLING112 reports
FATIGUE111 reports
CONFUSIONAL STATE109 reports
EYE IRRITATION108 reports
TYPE 2 DIABETES MELLITUS105 reports
PSORIATIC ARTHROPATHY104 reports
C REACTIVE PROTEIN INCREASED103 reports
MALAISE102 reports
URTICARIA102 reports
WOUND101 reports
RHEUMATOID ARTHRITIS100 reports
SYSTEMIC LUPUS ERYTHEMATOSUS100 reports
PERICARDITIS99 reports
ABDOMINAL DISCOMFORT95 reports
ARTHRALGIA95 reports
PRODUCT USE ISSUE95 reports
INFUSION RELATED REACTION93 reports
PEMPHIGUS93 reports
DIZZINESS92 reports
SYNOVITIS92 reports
PNEUMONIA89 reports
CONDITION AGGRAVATED88 reports
ANAPHYLACTIC REACTION87 reports
DEPRESSION86 reports
ERYTHEMA85 reports
HYPERTENSION85 reports
HYPOPYON84 reports
ABDOMINAL PAIN82 reports
BLINDNESS81 reports
OCULAR HYPERAEMIA79 reports
INFLAMMATION78 reports
BLISTER77 reports
CORNEAL OEDEMA77 reports
INTENTIONAL PRODUCT USE ISSUE76 reports
SLEEP DISORDER76 reports
DRUG INTOLERANCE74 reports
VITREOUS FLOATERS74 reports
ALOPECIA72 reports
DEATH72 reports
NASOPHARYNGITIS72 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE70 reports
EYE INFLAMMATION68 reports
TREATMENT FAILURE67 reports
VITRITIS67 reports
CONTRAINDICATED PRODUCT ADMINISTERED66 reports
HYPOTENSION66 reports
ILL DEFINED DISORDER66 reports
INTRAOCULAR PRESSURE INCREASED66 reports
ONYCHOMADESIS66 reports
STOMATITIS66 reports
DECREASED APPETITE65 reports
RHEUMATIC FEVER65 reports
ABDOMINAL PAIN UPPER64 reports
ANAEMIA64 reports
MATERNAL EXPOSURE DURING PREGNANCY64 reports
ONYCHOMYCOSIS64 reports
DISCOMFORT63 reports
ASTHENIA62 reports
FALL62 reports
GENERAL PHYSICAL HEALTH DETERIORATION62 reports
INJECTION SITE REACTION62 reports
CATARACT61 reports
THERAPEUTIC PRODUCT EFFECT DECREASED61 reports
C REACTIVE PROTEIN ABNORMAL60 reports
EPILEPSY59 reports
GASTROOESOPHAGEAL REFLUX DISEASE59 reports
HYPOAESTHESIA59 reports
JOINT SWELLING59 reports
SEPSIS58 reports
PRODUCT QUALITY ISSUE57 reports
BLINDNESS UNILATERAL56 reports
FIBROMYALGIA56 reports
INSOMNIA56 reports
WEIGHT INCREASED56 reports
PAIN IN EXTREMITY55 reports
DUODENAL ULCER PERFORATION54 reports
ANAPHYLACTIC SHOCK53 reports
LACRIMATION INCREASED52 reports
ANTERIOR CHAMBER CELL51 reports
DRY MOUTH51 reports

Report Outcomes

Out of 4,001 classified reports for POVIDONE IODINE:

Serious 83.6%Non-Serious 16.4%

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

Female2,158 (64.5%)
Male1,173 (35.1%)
Unknown13 (0.4%)

Reports by Age

Age 4094 reports
Age 7490 reports
Age 7375 reports
Age 4372 reports
Age 7071 reports
Age 4966 reports
Age 6664 reports
Age 7763 reports
Age 7161 reports
Age 6960 reports
Age 6458 reports
Age 7858 reports
Age 7958 reports
Age 6857 reports
Age 7556 reports
Age 7655 reports
Age 6353 reports
Age 6048 reports
Age 6248 reports
Age 6748 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 POVIDONE IODINE?

This profile reflects 10,103 FDA FAERS reports that mention POVIDONE IODINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for POVIDONE IODINE?

Frequently reported terms in FAERS include OFF LABEL USE, ENDOPHTHALMITIS, DRUG HYPERSENSITIVITY, TOXIC ANTERIOR SEGMENT SYNDROME, RASH, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures POVIDONE IODINE?

Labeling and FAERS entries often list Alcon Laboratories, Inc. in connection with POVIDONE IODINE. 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.