Drug · FAERS side-effect profile with label screen
Nystatin side effects: what 27,174 FDA adverse event reports show
Who reports
27,174 reports · 77% serious · 3,736 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
FDA label, Indications and Usage
What it is
DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula: C 47 H 75 NO 17 M.W. 926.13 Nystatin tablets are for oral administration and contain 500,000 units of nystatin per tablet.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
No label text to screen 40
What the badges mean
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,164 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Salpingo-oophorectomy unilateral | 48 | 598.2 409.9–872.9ROR 599.2 · calibrated p 6e-14 ✓ | 295.7 EB05 231.9 · IC025 +5.8 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=48 · ♀ 100% (drug 63%) | not reported in cached trials |
| Total lung capacity increased | 96 | 419.4 327.0–537.9ROR 420.9 · calibrated p 7e-13 ✓ | 256.8 EB05 216.5 · IC025 +6.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 96 | 174.6 139.9–217.9ROR 175.2 · calibrated p 2e-9 ✓ | 138.3 EB05 116.6 · IC025 +6.0 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Venous pressure jugular increased | 30 | 68.5 47.1–99.5ROR 68.6 · calibrated p 4e-6 ✓ | 60.6 EB05 44.5 · IC025 +4.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.5) | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 63%) | not reported in cached trials |
| Sinusitis fungal | 56 | 59.0 44.9–77.4ROR 59.1 · calibrated p 7e-6 ✓ | 53.8 EB05 43.0 · IC025 +4.8 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 100% (drug 63%) | not reported in cached trials |
| Trichoglossia | 26 | 52.1 35.1–77.6ROR 52.2 · calibrated p 2e-5 ✓ | 47.3 EB05 33.9 · IC025 +4.0 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 54 | 40.7 31.0–53.5ROR 40.8 · calibrated p 6e-5 ✓ | 38.2 EB05 30.4 · IC025 +4.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.1 (0.8–1.5) | No label text to screen label has no adverse-reaction text | serious n=54 | not reported in cached trials |
| Jaundice cholestatic | 174 | 39.8 34.2–46.4ROR 40.1 · calibrated p 6e-5 ✓ | 37.8 EB05 33.3 · IC025 +4.8 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.2) | No label text to screen label has no adverse-reaction text | serious n=174 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Hypomania | 181 | 39.8 34.3–46.2ROR 40.0 · calibrated p 6e-5 ✓ | 37.7 EB05 33.3 · IC025 +4.9 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.2) | No label text to screen label has no adverse-reaction text | serious n=181 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Nephrogenic anaemia | 199 | 34.3 29.7–39.5ROR 34.5 · calibrated p 1e-4 ✓ | 32.7 EB05 29.1 · IC025 +4.7 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.2) | No label text to screen label has no adverse-reaction text | serious n=199 | not reported in cached trials |
| Female genital tract fistula | 66 | 30.7 24.0–39.3ROR 30.8 · calibrated p 3e-4 ✓ | 29.3 EB05 23.9 · IC025 +4.2 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.3) | No label text to screen label has no adverse-reaction text | serious n=66 · ♀ 100% (drug 63%) | not reported in cached trials |
| Hyperparathyroidism secondary | 96 | 30.4 24.8–37.2ROR 30.5 · calibrated p 3e-4 ✓ | 29.1 EB05 24.5 · IC025 +4.3 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=96 | not reported in cached trials |
| Oral candidiasis (oral thrush) | 458 | 28.1 25.6–30.8ROR 28.6 · calibrated p 3e-4 ✓ | 27.1 EB05 25.1 · IC025 +4.6 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 22.3 | NCT01427738: 26/111 (23.4%) on Nystatin |
| Pelvic mass | 27 | 26.7 18.2–39.1ROR 26.7 · calibrated p 7e-4 ✓ | 25.4 EB05 18.3 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=27 · 100% clinician | not reported in cached trials |
| Sepsis neonatal | 26 | 25.7 17.4–38.0ROR 25.8 · calibrated p 9e-4 ✓ | 24.5 EB05 17.6 · IC025 +3.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=26 · 100% clinician | not reported in cached trials |
| Candida infection (yeast infection) | 522 | 24.9 22.8–27.1ROR 25.4 · calibrated p 6e-4 ✓ | 24.1 EB05 22.4 · IC025 +4.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 19.0 | not reported in cached trials |
| Nasal polyps | 150 | 24.7 21.0–29.1ROR 24.9 · calibrated p 7e-4 ✓ | 23.9 EB05 20.9 · IC025 +4.2 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.2) | No label text to screen label has no adverse-reaction text | serious n=150 · ♀ 100% (drug 63%) | not reported in cached trials |
| Sputum increased | 65 | 24.4 19.1–31.3ROR 24.5 · calibrated p 9e-4 ✓ | 23.6 EB05 19.1 · IC025 +3.9 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.3) | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 100% (drug 63%) | not reported in cached trials |
| Rhinitis allergic | 134 | 24.0 20.2–28.5ROR 24.1 · calibrated p 9e-4 ✓ | 23.2 EB05 20.1 · IC025 +4.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=131 · ♀ 92% (drug 63%) | not reported in cached trials |
| Kyphosis | 53 | 23.7 18.1–31.2ROR 23.8 · calibrated p 0.001 ✓ | 22.9 EB05 18.2 · IC025 +3.8 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=52 · ♀ 100% (drug 63%) | not reported in cached trials |
| Rectal prolapse | 34 | 22.3 15.9–31.4ROR 22.4 · calibrated p 0.002 ✓ | 21.5 EB05 16.1 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.5) | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 100% (drug 63%) | not reported in cached trials |
| Oropharyngeal candidiasis | 25 | 22.0 14.8–32.7ROR 22.0 · calibrated p 0.002 ✓ | 21.1 EB05 14.9 · IC025 +3.3 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 63%) | not reported in cached trials |
| Complications of transplanted kidney | 61 | 21.7 16.8–27.9ROR 21.7 · calibrated p 0.002 ✓ | 21.0 EB05 16.9 · IC025 +3.8 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=61 · ♀ 36% (drug 63%) · 100% clinician | not reported in cached trials |
| Parainfluenzae virus infection | 39 | 19.9 14.5–27.4ROR 19.9 · calibrated p 0.003 ✓ | 19.3 EB05 14.7 · IC025 +3.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.1 (0.7–1.6) | No label text to screen label has no adverse-reaction text | serious n=39 · 100% clinician | not reported in cached trials |
| Neutropenic infection | 24 | 19.6 13.1–29.4ROR 19.6 · calibrated p 0.003 ✓ | 18.8 EB05 13.2 · IC025 +3.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=24 · 100% clinician | not reported in cached trials |
| Chronic sinusitis | 88 | 18.5 15.0–22.9ROR 18.6 · calibrated p 0.003 ✓ | 18.0 EB05 15.1 · IC025 +3.7 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=85 · ♀ 100% (drug 63%) | not reported in cached trials |
| Sarcoidosis | 111 | 18.4 15.3–22.2ROR 18.5 · calibrated p 0.003 ✓ | 18.0 EB05 15.3 · IC025 +3.8 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=110 · ♀ 100% (drug 63%) · 90% clinician | not reported in cached trials |
| Infection reactivation | 26 | 17.9 12.1–26.4ROR 17.9 · calibrated p 0.005 ✓ | 17.2 EB05 12.2 · IC025 +3.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=26 · 100% clinician | not reported in cached trials |
| Candidiasis | 92 | 17.8 14.5–21.9ROR 17.9 · calibrated p 0.004 ✓ | 17.4 EB05 14.6 · IC025 +3.7 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=73 | NCT01427738: 1/110 (0.9%) on Nystatin (serious AE) |
| Oral fungal infection | 62 | 17.8 13.8–22.9ROR 17.8 · calibrated p 0.004 ✓ | 17.3 EB05 14.0 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=37 | not reported in cached trials |
| Mucormycosis | 58 | 17.8 13.7–23.0ROR 17.8 · calibrated p 0.004 ✓ | 17.3 EB05 13.8 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=58 · 100% clinician | not reported in cached trials |
| Diastolic dysfunction | 68 | 17.3 13.6–21.9ROR 17.3 · calibrated p 0.004 ✓ | 16.8 EB05 13.7 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.4) | No label text to screen label has no adverse-reaction text | serious n=68 · ♀ 100% (drug 63%) | not reported in cached trials |
| Pharyngeal ulceration | 29 | 17.2 11.9–24.8ROR 17.2 · calibrated p 0.005 ✓ | 16.6 EB05 12.0 · IC025 +3.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=26 · 100% clinician | not reported in cached trials |
| Respiratory symptom | 61 | 17.1 13.3–22.1ROR 17.2 · calibrated p 0.004 ✓ | 16.7 EB05 13.4 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.4) | No label text to screen label has no adverse-reaction text | serious n=60 · ♀ 100% (drug 63%) | not reported in cached trials |
| Bk virus infection | 71 | 16.7 13.2–21.1ROR 16.7 · calibrated p 0.005 ✓ | 16.3 EB05 13.3 · IC025 +3.5 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.3) | No label text to screen label has no adverse-reaction text | serious n=71 | not reported in cached trials |
| Rebound acid hypersecretion | 63 | 16.2 12.6–20.7ROR 16.2 · calibrated p 0.006 ✓ | 15.7 EB05 12.7 · IC025 +3.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.8–1.4) | No label text to screen label has no adverse-reaction text | serious n=63 | not reported in cached trials |
| Schizophrenia | 249 | 16.1 14.2–18.2ROR 16.2 · calibrated p 0.005 ✓ | 15.8 EB05 14.2 · IC025 +3.7 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.2) | No label text to screen label has no adverse-reaction text | serious PRR 12.2 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Chronic respiratory failure | 24 | 15.9 10.6–23.7ROR 15.9 · calibrated p 0.008 ✓ | 15.2 EB05 10.4 · IC025 +2.9 3/3 methods agree vs other Polyene Antifungals: only this drug | No label text to screen label has no adverse-reaction text | serious n=24 | not reported in cached trials |
| Tongue ulceration | 68 | 15.8 12.4–20.1ROR 15.8 · calibrated p 0.006 ✓ | 15.4 EB05 12.5 · IC025 +3.4 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.7–1.3) | No label text to screen label has no adverse-reaction text | serious n=65 · ♀ 84% (drug 63%) | not reported in cached trials |
| Vulvovaginal candidiasis | 26 | 15.3 10.4–22.6ROR 15.3 · calibrated p 0.008 ✓ | 14.6 EB05 10.2 · IC025 +2.9 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.6–1.6) | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 63%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Nystatin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT01427738 — Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis (N=221, PHASE3; 59 AE terms posted; arms: Gentian Violet; Nystatin)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 2,060 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.998 | 2.0 EB05 1.9 · IC025 +0.9 vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Fatigue (tiredness) | 1,850 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.888 | 1.8 EB05 1.8 · IC025 +0.8 vs other Polyene Antifungals: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,840 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.904 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | NCT01427738: 6/111 (5.4%) on Nystatin |
| Pneumonia (lung infection) | 1,685 | 4.0 3.9–4.2ROR 4.2 · calibrated p 0.336 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | NCT01427738: 1/111 (0.9%) on Nystatin (serious AE) |
| Dyspnoea (shortness of breath) | 1,537 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.969 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | not reported in cached trials |
| Off label use (used outside approved label) | 1,477 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.529 | 1.3 EB05 1.3 · IC025 +0.3 vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Vomiting | 1,405 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.863 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,290 | 0.8 0.7–0.8ROR 0.7 · calibrated p 0.153 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Pain | 1,279 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.728 | 1.6 EB05 1.5 · IC025 +0.6 vs other Polyene Antifungals: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | NCT01427738: 10/111 (9.0%) on Nystatin |
| Death | 1,220 | 1.1 1.0–1.2ROR 1.1 · calibrated p 0.371 | 1.1 EB05 1.0 · IC025 +0.0 vs other Polyene Antifungals: PRR 1.1 (1.0–1.1) | Outcome field, not a reaction | serious PRR 0.8 | NCT01427738: 1/111 (0.9%) on Nystatin (serious AE) |
| Pyrexia (fever) | 1,145 | 2.6 2.4–2.7ROR 2.6 · calibrated p 0.762 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | NCT01427738: 9/111 (8.1%) on Nystatin |
| Headache | 1,056 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.517 | 1.3 EB05 1.2 · IC025 +0.3 vs other Polyene Antifungals: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | not reported in cached trials |
| Rash | 990 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.825 | 1.8 EB05 1.7 · IC025 +0.7 vs other Polyene Antifungals: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | not reported in cached trials |
| Cough | 971 | 2.7 2.5–2.9ROR 2.7 · calibrated p 0.715 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | NCT01427738: 9/111 (8.1%) on Nystatin |
| Acute kidney injury (sudden kidney damage) | 971 | 4.9 4.6–5.3ROR 5.1 · calibrated p 0.225 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Nystatin?
In FDA FAERS, the most frequently co-reported reaction terms for Nystatin are nausea, fatigue, diarrhoea, pneumonia, dyspnoea, vomiting. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Nystatin have an FDA boxed warning?
No. The FDA label retrieved for Nystatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nystatin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 05cc72dd-8e05-bfb5-e063-6394a90a92f1, effective 20260819; matched on
openfda.generic_name.exact:"NYSTATIN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,204 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
NYSTATIN, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.