SODIUM POLYSTYRENE SULFONATE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

3,148 FDA adverse event reports analyzed

Last updated: 2026-04-15

About SODIUM POLYSTYRENE SULFONATE

SODIUM POLYSTYRENE SULFONATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for SODIUM POLYSTYRENE SULFONATE include HYPERKALAEMIA, DIARRHOEA, ACUTE KIDNEY INJURY, RENAL FAILURE, CONSTIPATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SODIUM POLYSTYRENE SULFONATE.

Top Adverse Reactions

HYPERKALAEMIA109 reports
DIARRHOEA105 reports
ACUTE KIDNEY INJURY99 reports
RENAL FAILURE95 reports
CONSTIPATION94 reports
CHRONIC KIDNEY DISEASE91 reports
DEATH82 reports
NAUSEA73 reports
VOMITING66 reports
END STAGE RENAL DISEASE65 reports
FATIGUE65 reports
DRUG INTERACTION56 reports
PNEUMONIA55 reports
OFF LABEL USE54 reports
DYSPNOEA50 reports
PAIN50 reports
ANAEMIA49 reports
ASTHENIA49 reports
PYREXIA49 reports
DRUG INEFFECTIVE46 reports
BLOOD POTASSIUM INCREASED43 reports
MALAISE43 reports
HOSPITALISATION40 reports
HYPOTENSION39 reports
DIZZINESS38 reports
HAEMOGLOBIN DECREASED37 reports
FALL36 reports
HYPERTENSION36 reports
RENAL IMPAIRMENT36 reports
BLOOD CREATININE INCREASED34 reports
SEPSIS34 reports
PRURITUS33 reports
ABDOMINAL PAIN32 reports
RENAL FAILURE ACUTE32 reports
ABDOMINAL PAIN UPPER31 reports
HEADACHE31 reports
DEHYDRATION30 reports
DRUG DOSE OMISSION30 reports
HYPOKALAEMIA28 reports
NEPHROGENIC ANAEMIA28 reports
RASH26 reports
ANXIETY25 reports
BRADYCARDIA25 reports
RENAL DISORDER25 reports
OEDEMA PERIPHERAL24 reports
ARTHRALGIA22 reports
CARDIAC FAILURE CONGESTIVE22 reports
CHEST PAIN22 reports
MUSCLE SPASMS22 reports
THROMBOCYTOPENIA22 reports
BLOOD GLUCOSE INCREASED21 reports
CARDIAC ARREST21 reports
LACTIC ACIDOSIS21 reports
PAIN IN EXTREMITY21 reports
RENAL INJURY21 reports
WEIGHT DECREASED21 reports
CHILLS20 reports
TACHYCARDIA20 reports
DEPRESSION19 reports
RESPIRATORY FAILURE19 reports
RHABDOMYOLYSIS19 reports
URINARY TRACT INFECTION19 reports
CARDIAC FAILURE18 reports
DECREASED APPETITE18 reports
GAIT DISTURBANCE18 reports
HYPERPARATHYROIDISM SECONDARY18 reports
METABOLIC ACIDOSIS18 reports
ABDOMINAL DISTENSION17 reports
ATRIAL FIBRILLATION17 reports
BACK PAIN17 reports
MUSCULAR WEAKNESS17 reports
PERIPHERAL SWELLING17 reports
PRODUCT DOSE OMISSION17 reports
SEPTIC SHOCK17 reports
BLOOD PRESSURE INCREASED16 reports
FLATULENCE16 reports
RECTAL HAEMORRHAGE16 reports
RENAL FAILURE CHRONIC16 reports
CONDITION AGGRAVATED15 reports
GASTROINTESTINAL HAEMORRHAGE15 reports
INFECTION15 reports
INTESTINAL ISCHAEMIA15 reports
MYOCARDIAL INFARCTION15 reports
SWELLING15 reports
ANHEDONIA14 reports
DIALYSIS14 reports
DRUG LEVEL CHANGED14 reports
ECONOMIC PROBLEM14 reports
EMOTIONAL DISTRESS14 reports
HYPONATRAEMIA14 reports
PANCYTOPENIA14 reports
FOETAL EXPOSURE DURING PREGNANCY13 reports
HYPERGLYCAEMIA13 reports
INSOMNIA13 reports
INTERNATIONAL NORMALISED RATIO INCREASED13 reports
LEUKOPENIA13 reports
NEUTROPENIA13 reports
OVERDOSE13 reports
PARAESTHESIA13 reports
PLATELET COUNT DECREASED13 reports

Report Outcomes

Out of 1,558 classified reports for SODIUM POLYSTYRENE SULFONATE:

Serious 77.2%Non-Serious 22.8%

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

Male831 (58.1%)
Female599 (41.9%)
Unknown1 (0.1%)

Reports by Age

Age 6443 reports
Age 5636 reports
Age 7536 reports
Age 6633 reports
Age 7933 reports
Age 6727 reports
Age 6827 reports
Age 7024 reports
Age 7124 reports
Age 7424 reports
Age 8324 reports
Age 6023 reports
Age 6322 reports
Age 6922 reports
Age 7322 reports
Age 8022 reports
Age 5921 reports
Age 6521 reports
Age 7221 reports
Age 7721 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 SODIUM POLYSTYRENE SULFONATE?

This profile reflects 3,148 FDA FAERS reports that mention SODIUM POLYSTYRENE SULFONATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SODIUM POLYSTYRENE SULFONATE?

Frequently reported terms in FAERS include HYPERKALAEMIA, DIARRHOEA, ACUTE KIDNEY INJURY, RENAL FAILURE, CONSTIPATION, CHRONIC KIDNEY DISEASE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SODIUM POLYSTYRENE SULFONATE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with SODIUM POLYSTYRENE SULFONATE. 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.