PENTOSAN POLYSULFATE SODIUM

N/A

Manufactured by Janssen Pharmaceuticals, Inc.

13,486 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PENTOSAN POLYSULFATE SODIUM

PENTOSAN POLYSULFATE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. The most commonly reported adverse reactions for PENTOSAN POLYSULFATE SODIUM include MACULOPATHY, OFF LABEL USE, RETINAL PIGMENTATION, DRY AGE-RELATED MACULAR DEGENERATION, PIGMENTARY MACULOPATHY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PENTOSAN POLYSULFATE SODIUM.

Top Adverse Reactions

MACULOPATHY1,390 reports
OFF LABEL USE1,385 reports
RETINAL PIGMENTATION607 reports
DRY AGE RELATED MACULAR DEGENERATION559 reports
PIGMENTARY MACULOPATHY456 reports
DRUG INEFFECTIVE341 reports
PAIN302 reports
PRODUCT USE ISSUE271 reports
NAUSEA267 reports
HEADACHE233 reports
CYSTITIS INTERSTITIAL213 reports
MACULAR DEGENERATION210 reports
DIARRHOEA207 reports
ALOPECIA205 reports
FATIGUE197 reports
AGE RELATED MACULAR DEGENERATION184 reports
DEPRESSION175 reports
ANXIETY170 reports
INCORRECT DOSE ADMINISTERED158 reports
DIZZINESS156 reports
VISUAL IMPAIRMENT150 reports
MALAISE146 reports
TOXICITY TO VARIOUS AGENTS143 reports
NEOVASCULAR AGE RELATED MACULAR DEGENERATION141 reports
RETINAL DYSTROPHY141 reports
VOMITING132 reports
VISION BLURRED119 reports
ARTHRALGIA117 reports
URINARY TRACT INFECTION116 reports
DRUG DOSE OMISSION115 reports
CONDITION AGGRAVATED107 reports
RETINOPATHY107 reports
ABDOMINAL PAIN106 reports
ASTHENIA105 reports
DYSPNOEA104 reports
FALL101 reports
VITREOUS DETACHMENT100 reports
WEIGHT DECREASED99 reports
INSOMNIA93 reports
RETINAL DEGENERATION92 reports
CONSTIPATION87 reports
SOMNOLENCE86 reports
BLINDNESS85 reports
RASH83 reports
PAIN IN EXTREMITY82 reports
ABDOMINAL PAIN UPPER81 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION81 reports
BACK PAIN80 reports
ADVERSE EVENT79 reports
BLADDER PAIN78 reports
PRURITUS77 reports
HYPERTENSION75 reports
ABDOMINAL DISCOMFORT74 reports
FEELING ABNORMAL74 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION73 reports
PYREXIA72 reports
RETINAL INJURY67 reports
MUSCLE SPASMS66 reports
WEIGHT INCREASED66 reports
MIGRAINE65 reports
DRY EYE63 reports
PRODUCT DOSE OMISSION ISSUE62 reports
DECREASED APPETITE60 reports
CYSTITIS58 reports
RETINAL TOXICITY55 reports
SINUSITIS55 reports
DRY MOUTH54 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS53 reports
CATARACT52 reports
COUGH52 reports
DEATH52 reports
PNEUMONIA52 reports
SURGERY52 reports
DRUG HYPERSENSITIVITY51 reports
GASTROOESOPHAGEAL REFLUX DISEASE51 reports
ABDOMINAL DISTENSION49 reports
ANAEMIA49 reports
CHEST PAIN49 reports
GAIT DISTURBANCE49 reports
PARAESTHESIA48 reports
TREATMENT NONCOMPLIANCE48 reports
DYSURIA47 reports
HYPERHIDROSIS47 reports
INJECTION SITE PAIN47 reports
CONFUSIONAL STATE46 reports
DYSPEPSIA46 reports
POLLAKIURIA46 reports
DRUG PRESCRIBING ERROR45 reports
HYPOAESTHESIA44 reports
BLADDER DISORDER43 reports
BLOOD PRESSURE INCREASED42 reports
DIABETES MELLITUS42 reports
MYALGIA42 reports
OEDEMA PERIPHERAL42 reports
RETINAL DRUSEN42 reports
STRESS42 reports
CROHN^S DISEASE41 reports
SWELLING40 reports
HYPERSENSITIVITY39 reports
ASTHMA38 reports

Frequently Asked Questions

How many FDA adverse event reports are associated with PENTOSAN POLYSULFATE SODIUM?

This profile reflects 13,486 FDA FAERS reports that mention PENTOSAN POLYSULFATE SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PENTOSAN POLYSULFATE SODIUM?

Frequently reported terms in FAERS include MACULOPATHY, OFF LABEL USE, RETINAL PIGMENTATION, DRY AGE-RELATED MACULAR DEGENERATION, PIGMENTARY MACULOPATHY, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PENTOSAN POLYSULFATE SODIUM?

Labeling and FAERS entries often list Janssen Pharmaceuticals, Inc. in connection with PENTOSAN POLYSULFATE SODIUM. 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.