Drug · FAERS side-effect profile with label screen
Nystatin Cream side effects: what 26,101 FDA adverse event reports show
Who reports
26,101 reports · 78% serious · 3,617 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
FDA label, Indications and Usage
What it is
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.
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
Lab value / disease marker 1No label text to screen 39
What the badges mean
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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). 1,171 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 | 622.8 426.7–908.8ROR 623.9 · calibrated p 4e-14 ✓ | 306.3 EB05 240.3 · 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 62%) | no trial arm names this drug |
| Total lung capacity increased | 96 | 436.7 340.4–560.0ROR 438.3 · calibrated p 5e-13 ✓ | 266.8 EB05 224.9 · 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 62%) · 100% clinician | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 96 | 181.8 145.7–226.8ROR 182.4 · calibrated p 1e-9 ✓ | 143.8 EB05 121.2 · IC025 +6.1 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=96 · ♀ 100% (drug 62%) · 100% clinician | no trial arm names this drug |
| Venous pressure jugular increased | 30 | 71.3 49.1–103.6ROR 71.4 · calibrated p 3e-6 ✓ | 63.0 EB05 46.2 · 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 62%) | no trial arm names this drug |
| Sinusitis fungal | 55 | 60.2 45.8–79.2ROR 60.3 · calibrated p 6e-6 ✓ | 55.0 EB05 43.9 · 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 62%) | no trial arm names this drug |
| Trichoglossia | 26 | 54.3 36.5–80.8ROR 54.3 · calibrated p 2e-5 ✓ | 49.2 EB05 35.3 · IC025 +4.1 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=25 · ♀ 0% (drug 62%) · 100% clinician | no trial arm names this drug |
| Jaundice cholestatic | 174 | 41.5 35.6–48.3ROR 41.7 · calibrated p 4e-5 ✓ | 39.3 EB05 34.6 · 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=174 · ♀ 100% (drug 62%) · 95% clinician | no trial arm names this drug |
| Hypomania | 181 | 41.4 35.7–48.1ROR 41.7 · calibrated p 4e-5 ✓ | 39.3 EB05 34.7 · 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 62%) · 94% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 51 | 39.9 30.1–52.9ROR 40.0 · calibrated p 7e-5 ✓ | 37.6 EB05 29.7 · IC025 +4.3 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=51 | no trial arm names this drug |
| Nephrogenic anaemia | 196 | 35.1 30.4–40.5ROR 35.4 · calibrated p 1e-4 ✓ | 33.6 EB05 29.8 · IC025 +4.7 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=196 | no trial arm names this drug |
| Female genital tract fistula | 66 | 32.0 25.0–40.9ROR 32.1 · calibrated p 2e-4 ✓ | 30.5 EB05 24.8 · 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 62%) | no trial arm names this drug |
| Hyperparathyroidism secondary | 95 | 31.3 25.5–38.4ROR 31.4 · calibrated p 2e-4 ✓ | 30.0 EB05 25.2 · IC025 +4.4 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=95 | no trial arm names this drug |
| Oral candidiasis (oral thrush) | 455 | 29.1 26.5–31.9ROR 29.6 · calibrated p 3e-4 ✓ | 28.1 EB05 26.0 · 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 23.0 | no trial arm names this drug |
| Pelvic mass | 27 | 27.8 18.9–40.7ROR 27.8 · calibrated p 6e-4 ✓ | 26.4 EB05 19.0 · 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 | no trial arm names this drug |
| Sepsis neonatal | 26 | 26.8 18.1–39.6ROR 26.8 · calibrated p 7e-4 ✓ | 25.5 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=26 · 100% clinician | no trial arm names this drug |
| Candida infection (yeast infection) | 518 | 25.7 23.6–28.0ROR 26.2 · calibrated p 5e-4 ✓ | 24.9 EB05 23.2 · IC025 +4.5 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 19.5 | no trial arm names this drug |
| Nasal polyps | 149 | 25.6 21.7–30.1ROR 25.7 · calibrated p 6e-4 ✓ | 24.7 EB05 21.6 · IC025 +4.3 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=149 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Sputum increased | 65 | 25.4 19.9–32.5ROR 25.5 · calibrated p 7e-4 ✓ | 24.5 EB05 19.9 · IC025 +4.0 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 62%) | no trial arm names this drug |
| Kyphosis | 53 | 24.7 18.8–32.5ROR 24.8 · calibrated p 9e-4 ✓ | 23.8 EB05 18.9 · 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=52 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Rhinitis allergic | 130 | 24.2 20.3–28.8ROR 24.3 · calibrated p 8e-4 ✓ | 23.4 EB05 20.2 · IC025 +4.1 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=128 · ♀ 92% (drug 62%) | no trial arm names this drug |
| Rectal prolapse | 34 | 23.3 16.5–32.7ROR 23.3 · calibrated p 0.001 ✓ | 22.4 EB05 16.7 · 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 62%) | no trial arm names this drug |
| Oropharyngeal candidiasis | 25 | 22.9 15.4–34.0ROR 22.9 · calibrated p 0.002 ✓ | 21.9 EB05 15.6 · 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 62%) | no trial arm names this drug |
| Complications of transplanted kidney | 61 | 22.5 17.5–29.1ROR 22.6 · calibrated p 0.001 ✓ | 21.8 EB05 17.6 · 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 62%) · 100% clinician | no trial arm names this drug |
| Neutropenic infection | 24 | 20.4 13.6–30.6ROR 20.4 · calibrated p 0.003 ✓ | 19.6 EB05 13.8 · IC025 +3.2 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 | no trial arm names this drug |
| Blood urea abnormal | 23 | 20.3 13.4–30.7ROR 20.3 · calibrated p 0.003 ✓ | 19.5 EB05 13.6 · IC025 +3.1 3/3 methods agree vs other Polyene Antifungals: PRR 2.0 (1.1–3.6) | Lab value / disease marker | serious n=22 | no trial arm names this drug |
| Parainfluenzae virus infection | 37 | 19.6 14.2–27.2ROR 19.7 · calibrated p 0.003 ✓ | 19.0 EB05 14.4 · IC025 +3.4 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 · 100% clinician | no trial arm names this drug |
| Sarcoidosis | 111 | 19.2 15.9–23.2ROR 19.3 · calibrated p 0.003 ✓ | 18.7 EB05 16.0 · 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 62%) · 90% clinician | no trial arm names this drug |
| Chronic sinusitis | 87 | 19.1 15.4–23.6ROR 19.1 · calibrated p 0.003 ✓ | 18.6 EB05 15.5 · 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=84 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Infection reactivation | 26 | 18.6 12.6–27.5ROR 18.7 · calibrated p 0.004 ✓ | 17.9 EB05 12.7 · 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 | no trial arm names this drug |
| Oral fungal infection | 62 | 18.5 14.4–23.8ROR 18.6 · calibrated p 0.003 ✓ | 18.0 EB05 14.5 · IC025 +3.6 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 | no trial arm names this drug |
| Mucormycosis | 58 | 18.5 14.3–24.0ROR 18.5 · calibrated p 0.003 ✓ | 18.0 EB05 14.4 · 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=58 · 100% clinician | no trial arm names this drug |
| Candidiasis | 91 | 18.3 14.9–22.6ROR 18.4 · calibrated p 0.003 ✓ | 17.9 EB05 15.0 · 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=72 | no trial arm names this drug |
| Pharyngeal ulceration | 29 | 17.9 12.4–25.9ROR 17.9 · calibrated p 0.004 ✓ | 17.3 EB05 12.5 · IC025 +3.2 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 | no trial arm names this drug |
| Respiratory symptom | 61 | 17.9 13.9–23.0ROR 17.9 · calibrated p 0.004 ✓ | 17.4 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=60 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Diastolic dysfunction | 67 | 17.7 13.9–22.5ROR 17.7 · calibrated p 0.004 ✓ | 17.2 EB05 14.0 · IC025 +3.5 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=67 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Bk virus infection | 71 | 17.4 13.7–22.0ROR 17.4 · calibrated p 0.004 ✓ | 16.9 EB05 13.9 · 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 | no trial arm names this drug |
| Schizophrenia | 249 | 16.8 14.8–19.0ROR 16.9 · calibrated p 0.004 ✓ | 16.4 EB05 14.8 · IC025 +3.8 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 12.6 · ♀ 100% (drug 62%) · 95% clinician | no trial arm names this drug |
| Rebound acid hypersecretion | 62 | 16.5 12.9–21.3ROR 16.6 · calibrated p 0.005 ✓ | 16.1 EB05 13.0 · 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=62 | no trial arm names this drug |
| Tongue ulceration | 68 | 16.4 12.9–20.9ROR 16.5 · calibrated p 0.005 ✓ | 16.0 EB05 13.0 · IC025 +3.5 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 62%) | no trial arm names this drug |
| Vulvovaginal candidiasis | 26 | 15.9 10.8–23.5ROR 16.0 · calibrated p 0.007 ✓ | 15.3 EB05 10.7 · IC025 +3.0 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=24 · ♀ 100% (drug 62%) | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Nystatin Cream (searched NYSTATIN CREAM).
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 | 1,981 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.999 | 2.0 EB05 1.9 · IC025 +0.9 vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,764 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.906 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Fatigue (tiredness) | 1,763 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.879 | 1.8 EB05 1.8 · IC025 +0.8 vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Pneumonia (lung infection) | 1,634 | 4.1 3.9–4.3ROR 4.3 · calibrated p 0.329 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,474 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.971 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,445 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.547 | 1.3 EB05 1.3 · IC025 +0.3 vs other Polyene Antifungals: PRR 1.0 (0.9–1.1) | Reporting / coding artifact | serious PRR 1.4 | no trial arm names this drug |
| Vomiting | 1,370 | 2.4 2.2–2.5ROR 2.4 · calibrated p 0.846 | 2.3 EB05 2.2 · IC025 +1.1 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 2.3 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,245 | 0.8 0.7–0.8ROR 0.7 · calibrated p 0.155 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Polyene Antifungals: PRR 1.0 (0.9–1.1) | Reporting / coding artifact | serious PRR 1.0 | no trial arm names this drug |
| Pain | 1,217 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.718 | 1.6 EB05 1.5 · IC025 +0.6 vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Death | 1,138 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.349 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | Outcome field, not a reaction | serious PRR 0.8 | no trial arm names this drug |
| Pyrexia (fever) | 1,126 | 2.6 2.5–2.8ROR 2.7 · calibrated p 0.736 | 2.6 EB05 2.5 · 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 | no trial arm names this drug |
| Headache | 1,003 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.507 | 1.3 EB05 1.2 · IC025 +0.3 vs other Polyene Antifungals: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial arm names this drug |
| Cough | 943 | 2.7 2.5–2.9ROR 2.8 · calibrated p 0.704 | 2.7 EB05 2.6 · 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 2.9 | no trial arm names this drug |
| Rash | 935 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.806 | 1.7 EB05 1.6 · IC025 +0.7 vs other Polyene Antifungals: PRR 1.0 (0.9–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 928 | 4.9 4.6–5.2ROR 5.1 · calibrated p 0.228 | 4.9 EB05 4.6 · IC025 +2.2 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 3.6 | no trial arm names this drug |
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 Cream?
In FDA FAERS, the most frequently co-reported reaction terms for Nystatin Cream are nausea, diarrhoea, fatigue, 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 Cream have an FDA boxed warning?
No. The FDA label retrieved for Nystatin Cream has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nystatin Cream 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 5a2b6fee-1437-0c3a-e053-2991aa0a3443, effective 20260112; matched on
openfda.generic_name.exact:"NYSTATIN CREAM" 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, 1,211 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 CREAM, 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.