Drug · FAERS side-effect profile with label screen
Fluconazole side effects: what 69,652 FDA adverse event reports show
Who reports
69,652 reports · 85% serious · 12,476 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Fluconazole tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida ). Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablet.
FDA label, Indications and Usage
What it is
DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-diflu.
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
Labeled (related wording) 1Likely indication confounding 12Not in label — unassessed 27
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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). 1,203 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 166 | 361.3 288.0–453.2ROR 362.1 · calibrated p 3e-12 ✓ | 160.3 EB05 140.8 · IC025 +6.5 3/3 methods agree vs other Azole Antifungals: PRR 9.2 (7.7–10.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=166 · ♀ 100% (drug 58%) | not reported in cached trials |
| Disseminated mucormycosis | 74 | 70.9 55.0–91.3ROR 71.0 · calibrated p 2e-6 ✓ | 56.6 EB05 46.6 · IC025 +5.0 3/3 methods agree vs other Azole Antifungals: PRR 15.6 (11.9–20.5) | Not in label — unassessed | serious n=74 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Meningitis cryptococcal | 287 | 59.8 52.7–67.9ROR 60.1 · calibrated p 4e-6 ✓ | 49.8 EB05 45.1 · IC025 +5.3 3/3 methods agree vs other Azole Antifungals: PRR 180.6 (136.8–238.4) | Likely indication confounding term in indications; also in warnings | serious n=286 · ♀ 26% (drug 58%) · 94% clinician | not reported in cached trials |
| Cryptococcosis | 226 | 49.0 42.6–56.4ROR 49.2 · calibrated p 2e-5 ✓ | 42.1 EB05 37.7 · IC025 +5.1 3/3 methods agree vs other Azole Antifungals: PRR 104.0 (80.8–133.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=226 · ♀ 35% (drug 58%) · 100% clinician | not reported in cached trials |
| Female genital tract fistula | 235 | 47.5 41.4–54.5ROR 47.7 · calibrated p 2e-5 ✓ | 41.0 EB05 36.7 · IC025 +5.0 3/3 methods agree vs other Azole Antifungals: PRR 12.3 (10.6–14.3) | Not in label — unassessed | serious n=234 · ♀ 100% (drug 58%) | not reported in cached trials |
| Temperature regulation disorder | 258 | 40.2 35.3–45.8ROR 40.4 · calibrated p 5e-5 ✓ | 35.4 EB05 32.0 · IC025 +4.9 3/3 methods agree vs other Azole Antifungals: PRR 216.4 (157.7–297.0) | Not in label — unassessed | serious n=258 · ♀ 100% (drug 58%) | not reported in cached trials |
| Skin candida | 58 | 38.0 28.9–49.9ROR 38.0 · calibrated p 9e-5 ✓ | 33.4 EB05 26.8 · IC025 +4.3 3/3 methods agree vs other Azole Antifungals: PRR 21.7 (15.7–29.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=57 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Mucormycosis | 287 | 37.7 33.3–42.6ROR 37.8 · calibrated p 8e-5 ✓ | 33.5 EB05 30.4 · IC025 +4.8 3/3 methods agree vs other Azole Antifungals: PRR 10.2 (9.0–11.6) | Not in label — unassessed | serious n=287 · 92% clinician | not reported in cached trials |
| Disseminated cryptococcosis | 80 | 36.7 29.1–46.2ROR 36.7 · calibrated p 1e-4 ✓ | 32.5 EB05 26.9 · IC025 +4.4 3/3 methods agree vs other Azole Antifungals: PRR 60.4 (42.4–86.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=80 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Engraftment syndrome | 62 | 35.4 27.2–46.1ROR 35.5 · calibrated p 1e-4 ✓ | 31.5 EB05 25.4 · IC025 +4.2 3/3 methods agree vs other Azole Antifungals: PRR 68.8 (45.3–104.6) | Not in label — unassessed | serious n=61 · ♀ 0% (drug 58%) | not reported in cached trials |
| Immune reconstitution syndrome | 132 | 33.7 28.2–40.4ROR 33.8 · calibrated p 2e-4 ✓ | 30.2 EB05 26.2 · IC025 +4.5 3/3 methods agree vs other Azole Antifungals: PRR 332.2 (194.8–566.6) | Not in label — unassessed | serious n=132 · ♀ 33% (drug 58%) · 100% clinician | not reported in cached trials |
| Coccidioidomycosis | 117 | 32.6 26.9–39.5ROR 32.7 · calibrated p 2e-4 ✓ | 29.3 EB05 25.1 · IC025 +4.4 3/3 methods agree vs other Azole Antifungals: PRR 43.7 (33.5–57.1) | Not in label — unassessed | serious n=114 | not reported in cached trials |
| Cerebral toxoplasmosis | 87 | 30.8 24.7–38.4ROR 30.8 · calibrated p 3e-4 ✓ | 27.8 EB05 23.3 · IC025 +4.2 3/3 methods agree vs other Azole Antifungals: PRR 53.8 (38.8–74.7) | Not in label — unassessed | serious n=87 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Fungaemia | 145 | 30.7 25.9–36.4ROR 30.7 · calibrated p 3e-4 ✓ | 27.8 EB05 24.2 · IC025 +4.4 3/3 methods agree vs other Azole Antifungals: PRR 16.2 (13.3–19.7) | Not in label — unassessed | serious n=143 · 100% clinician | not reported in cached trials |
| Sinusitis fungal | 71 | 29.7 23.3–37.9ROR 29.8 · calibrated p 3e-4 ✓ | 26.9 EB05 22.1 · IC025 +4.1 3/3 methods agree vs other Azole Antifungals: PRR 19.1 (14.4–25.5) | Not in label — unassessed | serious n=71 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Candida sepsis | 81 | 29.7 23.6–37.3ROR 29.7 · calibrated p 3e-4 ✓ | 26.9 EB05 22.4 · IC025 +4.2 3/3 methods agree vs other Azole Antifungals: PRR 145.6 (90.1–235.3) | Likely indication confounding shares a disease stem with the indications wording | serious n=81 · 100% clinician | not reported in cached trials |
| Systemic mycosis | 102 | 28.8 23.5–35.2ROR 28.8 · calibrated p 4e-4 ✓ | 26.2 EB05 22.2 · IC025 +4.2 3/3 methods agree vs other Azole Antifungals: PRR 7.3 (5.9–9.0) | Not in label — unassessed | serious n=102 · ♀ 33% (drug 58%) · 100% clinician | not reported in cached trials |
| Systemic candida | 210 | 27.9 24.2–32.2ROR 28.0 · calibrated p 4e-4 ✓ | 25.6 EB05 22.8 · IC025 +4.4 3/3 methods agree vs other Azole Antifungals: PRR 22.3 (18.8–26.5) | Likely indication confounding term in indications | serious n=209 · 92% clinician | not reported in cached trials |
| Pneumonia cryptococcal | 78 | 27.4 21.7–34.5ROR 27.4 · calibrated p 5e-4 ✓ | 25.0 EB05 20.7 · IC025 +4.1 3/3 methods agree vs other Azole Antifungals: PRR 95.0 (62.7–144.0) | Likely indication confounding term in indications | serious n=78 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Fungal sepsis | 61 | 23.6 18.2–30.6ROR 23.6 · calibrated p 0.001 ✓ | 21.8 EB05 17.6 · IC025 +3.8 3/3 methods agree vs other Azole Antifungals: PRR 26.8 (19.3–37.2) | Not in label — unassessed | serious n=61 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Aplastic anaemia | 380 | 23.5 21.1–26.0ROR 23.6 · calibrated p 9e-4 ✓ | 21.8 EB05 20.0 · IC025 +4.2 3/3 methods agree vs other Azole Antifungals: PRR 41.6 (36.0–48.1) | Not in label — unassessed | serious n=380 · 93% clinician | not reported in cached trials |
| Radiculopathy | 189 | 23.2 20.0–26.9ROR 23.2 · calibrated p 0.001 ✓ | 21.5 EB05 19.1 · IC025 +4.1 3/3 methods agree vs other Azole Antifungals: PRR 10.0 (8.5–11.7) | Not in label — unassessed | serious n=189 · ♀ 100% (drug 58%) | not reported in cached trials |
| Dysbiosis | 57 | 23.0 17.6–30.1ROR 23.0 · calibrated p 0.001 ✓ | 21.3 EB05 17.0 · IC025 +3.7 3/3 methods agree vs other Azole Antifungals: PRR 35.9 (25.0–51.5) | Not in label — unassessed | serious n=57 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Acinetobacter infection | 77 | 23.0 18.2–29.0ROR 23.0 · calibrated p 0.001 ✓ | 21.3 EB05 17.6 · IC025 +3.9 3/3 methods agree vs other Azole Antifungals: PRR 33.8 (24.9–46.0) | Not in label — unassessed | serious n=77 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Aspergillosis | 91 | 22.1 17.9–27.4ROR 22.2 · calibrated p 0.001 ✓ | 20.6 EB05 17.3 · IC025 +3.9 3/3 methods agree vs other Azole Antifungals: PRR 10.1 (8.0–12.7) | Not in label — unassessed | serious n=91 · 100% clinician | not reported in cached trials |
| Enterococcal sepsis | 56 | 22.1 16.8–29.0ROR 22.1 · calibrated p 0.001 ✓ | 20.5 EB05 16.4 · IC025 +3.7 3/3 methods agree vs other Azole Antifungals: PRR 20.5 (14.8–28.4) | Not in label — unassessed | serious n=56 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Proctitis | 186 | 21.3 18.4–24.7ROR 21.4 · calibrated p 0.002 ✓ | 19.9 EB05 17.6 · IC025 +4.0 3/3 methods agree vs other Azole Antifungals: PRR 9.9 (8.5–11.7) | Not in label — unassessed | serious n=186 · ♀ 100% (drug 58%) | not reported in cached trials |
| Chronic sinusitis | 243 | 20.8 18.3–23.7ROR 20.9 · calibrated p 0.002 ✓ | 19.5 EB05 17.5 · IC025 +4.0 3/3 methods agree vs other Azole Antifungals: PRR 8.9 (7.7–10.2) | Not in label — unassessed | serious n=236 · ♀ 100% (drug 58%) | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 68 | 20.2 15.8–25.9ROR 20.3 · calibrated p 0.002 ✓ | 18.9 EB05 15.4 · IC025 +3.7 3/3 methods agree vs other Azole Antifungals: PRR 15.7 (11.9–20.9) | Not in label — unassessed | serious n=68 | not reported in cached trials |
| Foetal death | 326 | 20.1 18.0–22.5ROR 20.2 · calibrated p 0.002 ✓ | 18.9 EB05 17.2 · IC025 +4.0 3/3 methods agree vs other Azole Antifungals: only this drug | Not in label — unassessed | serious n=326 · ♀ 100% (drug 58%) | not reported in cached trials |
| Immune reconstitution inflammatory syndrome | 314 | 20.1 17.9–22.5ROR 20.2 · calibrated p 0.002 ✓ | 18.9 EB05 17.2 · IC025 +4.0 3/3 methods agree vs other Azole Antifungals: PRR 66.6 (55.4–80.0) | Not in label — unassessed | serious n=313 · ♀ 21% (drug 58%) · 91% clinician | not reported in cached trials |
| Enterococcal bacteraemia | 65 | 19.7 15.3–25.3ROR 19.7 · calibrated p 0.002 ✓ | 18.4 EB05 15.0 · IC025 +3.6 3/3 methods agree vs other Azole Antifungals: PRR 17.9 (13.3–24.1) | Not in label — unassessed | serious n=65 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Toxoplasmosis | 66 | 19.5 15.2–25.0ROR 19.5 · calibrated p 0.003 ✓ | 18.2 EB05 14.8 · IC025 +3.6 3/3 methods agree vs other Azole Antifungals: PRR 37.2 (26.5–52.2) | Not in label — unassessed | serious n=66 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Oral candidiasis (oral thrush) | 783 | 19.2 17.9–20.7ROR 19.4 · calibrated p 0.002 ✓ | 18.1 EB05 17.1 · IC025 +4.0 3/3 methods agree vs other Azole Antifungals: PRR 22.5 (20.6–24.6) | Labeled (related wording) related wording | serious PRR 15.8 | not reported in cached trials |
| Stenotrophomonas infection | 80 | 19.1 15.2–23.9ROR 19.1 · calibrated p 0.003 ✓ | 17.9 EB05 14.8 · IC025 +3.7 3/3 methods agree vs other Azole Antifungals: PRR 16.7 (12.8–21.7) | Not in label — unassessed | serious n=80 · 100% clinician | not reported in cached trials |
| Oesophageal candidiasis | 236 | 19.1 16.7–21.7ROR 19.1 · calibrated p 0.003 ✓ | 17.9 EB05 16.1 · IC025 +3.9 3/3 methods agree vs other Azole Antifungals: PRR 103.6 (81.0–132.6) | Likely indication confounding term in indications | serious n=233 | not reported in cached trials |
| Candidiasis | 239 | 18.7 16.4–21.3ROR 18.8 · calibrated p 0.003 ✓ | 17.6 EB05 15.8 · IC025 +3.9 3/3 methods agree vs other Azole Antifungals: PRR 35.4 (29.7–42.2) | Likely indication confounding term in indications; also in warnings | serious n=224 | not reported in cached trials |
| Vulvovaginal candidiasis | 78 | 18.6 14.8–23.4ROR 18.7 · calibrated p 0.003 ✓ | 17.5 EB05 14.5 · IC025 +3.6 3/3 methods agree vs other Azole Antifungals: PRR 18.2 (13.9–23.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=64 · ♀ 100% (drug 58%) | not reported in cached trials |
| Enterococcal infection | 274 | 18.0 15.9–20.3ROR 18.1 · calibrated p 0.003 ✓ | 17.0 EB05 15.4 · IC025 +3.8 3/3 methods agree vs other Azole Antifungals: PRR 19.9 (17.2–23.0) | Not in label — unassessed | serious n=271 · 100% clinician | not reported in cached trials |
| Candida infection (yeast infection) | 919 | 17.5 16.4–18.7ROR 17.7 · calibrated p 0.003 ✓ | 16.6 EB05 15.7 · IC025 +3.9 3/3 methods agree vs other Azole Antifungals: PRR 22.6 (20.9–24.6) | Likely indication confounding term in indications | age-adj. PRR 17.3 · serious PRR 14.7 | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Neutropenia / agranulocytosis | 5,277 | 6.56.4–6.7 | signal |
| Severe cutaneous reaction | 1,449 | 6.05.7–6.3 | signal |
| Thrombocytopenia | 3,555 | 4.94.8–5.1 | signal |
| Opportunistic infection | 2,165 | 4.84.6–5.0 | signal |
| Kidney injury | 5,486 | 3.63.6–3.7 | signal |
| Anaemia | 3,429 | 3.53.4–3.6 | signal |
| Liver injury | 3,333 | 3.43.2–3.5 | signal |
| Hyponatraemia | 877 | 3.33.1–3.5 | signal |
| Serious infection | 7,999 | 3.13.1–3.2 | signal |
| Arrhythmia / qt | 1,787 | 2.82.7–2.9 | signal |
| Venous thromboembolism | 1,709 | 2.42.3–2.5 | signal |
| Pancreatitis | 629 | 2.42.2–2.5 | signal |
| Interstitial lung disease | 665 | 2.11.9–2.3 | raised |
| Rhabdomyolysis / myopathy | 560 | 2.11.9–2.3 | raised |
| Gi bleeding | 1,198 | 2.01.9–2.1 | raised |
| Heart failure | 999 | 1.71.6–1.8 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Fluconazole 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 (0 of 40 signal terms matched).
- NCT00075803 — Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN (N=600, PHASE3; 68 AE terms posted; arms: Fluconazole; Voriconazole)
- NCT01307579 — Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemother (N=517, PHASE3; 94 AE terms posted; arms: Arm I (Caspofungin Acetate); Arm II (Fluconazole))
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 5,160 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.436 | 1.2 EB05 1.2 · IC025 +0.2 vs other Azole Antifungals: PRR 8.9 (8.6–9.1) | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 1.9 | not reported in cached trials |
| Off label use (used outside approved label) | 4,567 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.724 | 1.6 EB05 1.5 · IC025 +0.6 vs other Azole Antifungals: PRR 12.7 (12.3–13.1) | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.8 | not reported in cached trials |
| Pyrexia (fever) | 4,205 | 3.7 3.6–3.8ROR 3.9 · calibrated p 0.404 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Azole Antifungals: PRR 21.3 (20.6–22.1) | Labeled (related wording) related wording | age-adj. PRR 3.0 · serious PRR 3.0 | not reported in cached trials |
| Nausea | 3,811 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.630 | 1.5 EB05 1.4 · IC025 +0.5 vs other Azole Antifungals: PRR 18.6 (17.9–19.3) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | NCT00075803: 25/295 (8.5%) on Fluconazole |
| Diarrhoea (diarrhea) | 3,613 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.789 | 1.7 EB05 1.6 · IC025 +0.7 vs other Azole Antifungals: PRR 19.9 (19.2–20.7) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.7 | NCT01307579: 1/253 (0.4%) on Fluconazole |
| Fatigue (tiredness) | 3,263 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.493 | 1.3 EB05 1.2 · IC025 +0.3 vs other Azole Antifungals: PRR 18.9 (18.2–19.7) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Pain | 3,181 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.697 | 1.6 EB05 1.5 · IC025 +0.6 vs other Azole Antifungals: PRR 21.0 (20.2–21.9) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.5 · ♀ 78% (drug 58%) | NCT00075803: 1/295 (0.3%) on Fluconazole (serious AE) |
| Drug interaction | 3,039 | 5.9 5.7–6.1ROR 6.1 · calibrated p 0.145 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree vs other Azole Antifungals: PRR 11.4 (11.0–11.8) | Reporting / coding artifact | age-adj. PRR 4.9 · serious PRR 4.1 | not reported in cached trials |
| Headache | 2,930 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.594 | 1.4 EB05 1.4 · IC025 +0.4 vs other Azole Antifungals: PRR 18.5 (17.7–19.3) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.6 · ♀ 80% (drug 58%) | not reported in cached trials |
| Pneumonia (lung infection) | 2,918 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.692 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Azole Antifungals: PRR 18.3 (17.5–19.0) | Likely indication confounding term in indications | age-adj. PRR 2.5 · serious PRR 1.9 | not reported in cached trials |
| Febrile neutropenia | 2,717 | 12.8 12.4–13.3ROR 13.3 · calibrated p 0.011 ✓ | 12.3 EB05 12.0 · IC025 +3.6 3/3 methods agree vs other Azole Antifungals: PRR 21.7 (20.7–22.7) | Labeled (related wording) related wording | age-adj. PRR 10.9 · serious PRR 8.4 · 94% clinician | NCT01307579: 2/253 (0.8%) on Fluconazole (serious AE) |
| Rash | 2,489 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.805 | 1.7 EB05 1.7 · IC025 +0.7 vs other Azole Antifungals: PRR 18.3 (17.5–19.2) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 2.0 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,466 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.525 | 1.3 EB05 1.3 · IC025 +0.3 vs other Azole Antifungals: PRR 14.1 (13.5–14.7) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.1 | NCT00075803: 43/295 (14.6%) on Fluconazole (serious AE) |
| Vomiting | 2,396 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.681 | 1.5 EB05 1.5 · IC025 +0.6 vs other Azole Antifungals: PRR 20.4 (19.4–21.4) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT00075803: 15/295 (5.1%) on Fluconazole |
| Death | 2,191 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.160 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Azole Antifungals: PRR 13.0 (12.4–13.6) | Outcome field, not a reaction | age-adj. PRR 0.8 · serious PRR 0.5 | NCT00075803: 1/305 (0.3%) on Fluconazole (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Disseminated mucormycosis — n=74, PRR 70.9
- Female genital tract fistula — n=235, PRR 47.5
- Temperature regulation disorder — n=258, PRR 40.2
- Mucormycosis — n=287, PRR 37.7
- Engraftment syndrome — n=62, PRR 35.4
- Immune reconstitution syndrome — n=132, PRR 33.7
- Coccidioidomycosis — n=117, PRR 32.6
- Cerebral toxoplasmosis — n=87, PRR 30.8
- Fungaemia — n=145, PRR 30.7
- Sinusitis fungal — n=71, PRR 29.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Fluconazole ↔ QT prolongation / torsades.
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 Fluconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Fluconazole are pyrexia, nausea, diarrhoea, fatigue, pain, headache. 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 Fluconazole have an FDA boxed warning?
No. The FDA label retrieved for Fluconazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluconazole 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 08a54805-4fdf-48fd-bc3e-e9fa38f3c691, effective 20230206; matched on
openfda.generic_name.exact:"FLUCONAZOLE") - 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, 1,243 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
FLUCONAZOLE, 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.