This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
Not available.
ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (See PRECAUTIONS: General ). Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic : Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been reported.
Source: FDA SPL label for NYSTATIN (Genus Lifesciences Inc.), effective 20260507. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 2,863 | 2,823 | 2,177 | 1,890 | 1,909 | 1,824 | 1,803 | 890 |
1,149 reports blaming this drug for every million Medicare prescriptions filled, which is 0.4× the typical drug on this site. (4,501 reports in 2024–2026, against 3,917,980 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 06/2026 | Class II | Padagis US LLC | Subpotent Drug: Low out of specification assay results performed during long-term stability testing. |
| 07/2021 | Class II | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. |
| 08/2020 | Class II | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Subpotent drug: Out of specification for assay at the 15-month test interval. |
| 03/2020 | Class II | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | SubPotent Drug: Low out-of-specification results for assay testing. |
| 01/2020 | Class II | Pharmaceutical Associates Inc | Subpotent: Out of specification for assay at the 12-month time point. |
| 05/2018 | Class III | Pharmaceutical Associates Inc | Resuspension problems: Out of specification for appearance and resuspendability. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Nystatin | 2,998,339 | $18 |
| Nystop | 440,088 | $25 |
| Nyamyc | 349,852 | $27 |
| Klayesta | 129,701 | $24 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.