Drug Safety Information for NILSTAT (Nystatin)

Adverse Drug Reactions for NILSTAT* (Nystatin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NILSTAT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*558
2Diarrhoea*550
3Pyrexia514
4Dyspnoea*501
5Pneumonia478
6Vomiting478
7Fatigue*448
8Pain*427
9Asthenia380
10Anaemia350
11Hypotension324
12Dehydration321
13Renal failure acute315
14Sepsis304
15Abdominal pain*298
16Anxiety296
17Rash276
18Oedema peripheral275
19Death270
20Dizziness265

* This side effect also appears in "Top 10 Side Effects of NILSTAT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NILSTAT
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication4514
2Fungal infection*773
3Oral candidiasis698
4Candidiasis*592
5Prophylaxis425
6Rash311
7Antifungal prophylaxis285
8Mucosal inflammation262
9Infection prophylaxis204
10Infection137

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for NILSTAT

Total Reports Filed with FDA: 55221


Number of FDA Adverse Event Reports by Patient Age for NILSTAT

Total Reports Filed with FDA: 55221*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nystatin (Mykinac, Nystex, Korostatin, Barstatin 100, Nysert, Pedi-dri, Nyamyc, Nilstat, Nystatin, Nystop, Mycostatin, Candex)

Charts are based on 55221 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and NILSTAT Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.