NYSTATIN

N/A

Manufactured by Padagis US LLC

59,130 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NYSTATIN

NYSTATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Padagis US LLC. The most commonly reported adverse reactions for NYSTATIN include NAUSEA, FATIGUE, DIARRHOEA, PNEUMONIA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NYSTATIN.

Top Adverse Reactions

NAUSEA1,964 reports
FATIGUE1,801 reports
DIARRHOEA1,788 reports
PNEUMONIA1,612 reports
DYSPNOEA1,483 reports
OFF LABEL USE1,376 reports
VOMITING1,328 reports
PAIN1,253 reports
DRUG INEFFECTIVE1,231 reports
DEATH1,188 reports
PYREXIA1,110 reports
HEADACHE1,006 reports
RASH960 reports
ACUTE KIDNEY INJURY957 reports
ASTHENIA935 reports
COUGH933 reports
CHRONIC KIDNEY DISEASE889 reports
URINARY TRACT INFECTION859 reports
RENAL FAILURE855 reports
FALL799 reports
DIZZINESS798 reports
MALAISE793 reports
ARTHRALGIA790 reports
ANXIETY753 reports
WEIGHT DECREASED737 reports
ANAEMIA736 reports
CONDITION AGGRAVATED714 reports
SEPSIS711 reports
FEBRILE NEUTROPENIA675 reports
DECREASED APPETITE671 reports
CONSTIPATION653 reports
ABDOMINAL PAIN640 reports
OEDEMA PERIPHERAL622 reports
PRURITUS622 reports
PAIN IN EXTREMITY617 reports
BACK PAIN592 reports
DEHYDRATION586 reports
HYPOTENSION567 reports
INSOMNIA567 reports
HYPERTENSION552 reports
DEPRESSION514 reports
CANDIDA INFECTION506 reports
NEUTROPENIA506 reports
GASTROOESOPHAGEAL REFLUX DISEASE484 reports
SINUSITIS470 reports
THROMBOCYTOPENIA457 reports
INFECTION448 reports
ORAL CANDIDIASIS444 reports
WEIGHT INCREASED437 reports
CHEST PAIN434 reports
DYSPHAGIA433 reports
GAIT DISTURBANCE428 reports
ASTHMA415 reports
MUSCLE SPASMS406 reports
ATRIAL FIBRILLATION403 reports
PRODUCT USE IN UNAPPROVED INDICATION387 reports
DRUG HYPERSENSITIVITY385 reports
PRODUCT DOSE OMISSION ISSUE381 reports
RESPIRATORY FAILURE379 reports
CONFUSIONAL STATE378 reports
PERIPHERAL SWELLING373 reports
STOMATITIS366 reports
COVID 19363 reports
ABDOMINAL PAIN UPPER357 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE354 reports
NASOPHARYNGITIS353 reports
ERYTHEMA349 reports
PULMONARY EMBOLISM347 reports
WHEEZING347 reports
OROPHARYNGEAL PAIN343 reports
TREMOR343 reports
HAEMOGLOBIN DECREASED342 reports
DRUG INTERACTION341 reports
BLOOD PRESSURE INCREASED336 reports
PLEURAL EFFUSION334 reports
HYPERSENSITIVITY333 reports
DISEASE PROGRESSION330 reports
FUNGAL INFECTION328 reports
CARDIAC FAILURE CONGESTIVE325 reports
ALOPECIA324 reports
CELLULITIS323 reports
PLATELET COUNT DECREASED317 reports
FEELING ABNORMAL316 reports
MUSCULAR WEAKNESS316 reports
SOMNOLENCE309 reports
NEUROPATHY PERIPHERAL307 reports
HYPOAESTHESIA306 reports
BLOOD CREATININE INCREASED298 reports
END STAGE RENAL DISEASE291 reports
CHOLELITHIASIS287 reports
PANCYTOPENIA287 reports
BRONCHITIS282 reports
DEEP VEIN THROMBOSIS281 reports
EMOTIONAL DISTRESS279 reports
ABDOMINAL DISCOMFORT277 reports
CHILLS274 reports
HEPATIC ENZYME INCREASED273 reports
WHITE BLOOD CELL COUNT DECREASED268 reports
PARAESTHESIA267 reports
PRODUCTIVE COUGH266 reports

Report Outcomes

Out of 26,233 classified reports for NYSTATIN:

Serious 77.7%Non-Serious 22.3%

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

Female15,169 (62.5%)
Male9,076 (37.4%)
Unknown43 (0.2%)

Reports by Age

Age 66492 reports
Age 67472 reports
Age 63467 reports
Age 52461 reports
Age 62453 reports
Age 68442 reports
Age 72440 reports
Age 70437 reports
Age 65436 reports
Age 60428 reports
Age 59424 reports
Age 74423 reports
Age 71418 reports
Age 69414 reports
Age 73409 reports
Age 58407 reports
Age 64395 reports
Age 57392 reports
Age 61392 reports
Age 55356 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 NYSTATIN?

This profile reflects 59,130 FDA FAERS reports that mention NYSTATIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NYSTATIN?

Frequently reported terms in FAERS include NAUSEA, FATIGUE, DIARRHOEA, PNEUMONIA, DYSPNOEA, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NYSTATIN?

Labeling and FAERS entries often list Padagis US LLC in connection with NYSTATIN. 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.