Terconazole side effects: what 822 FDA adverse event reports show

Terconazole · 27 reaction terms · 355 drug–reaction co-reports · data 2026-09-14

Drug class

Azole Antifungal

FDA label (Established Pharmacologic Class) · compare the class

Who reports

822 reports · 55% serious · 23 with death outcome · 97% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Terconazole Vaginal Suppositories, 80 mg is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.

FDA label, Indications and Usage

What it is

DESCRIPTION Terconazole Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis -1-[ p -[[2-(2,4-Di.

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 18 strongest signals

Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 12

What the badges mean

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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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.

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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 9 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
End stage renal disease	18	25.0 15.8–39.4ROR 25.5 · χ² 390 / p 4e-87	24.3 EB05 16.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.1	no trial data cached
Chronic kidney disease	68	22.6 18.0–28.4ROR 24.6 · χ² 1,389 / p <1e-300	22.5 EB05 18.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.1	no trial data cached
Impaired gastric emptying	10	20.0 10.8–37.1ROR 20.3 · χ² 162 / p 2e-37	18.8 EB05 10.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 21.2	no trial data cached
Fungal infection	25	19.2 13.0–28.2ROR 19.7 · χ² 413 / p 4e-92	18.9 EB05 13.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 17.6	no trial data cached
Vaginal discharge	7	17.8 8.5–37.2ROR 17.9 · χ² 95 / p 1e-22	15.2 EB05 6.2 · IC025 +1.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=4	no trial data cached
Premature delivery	9	14.4 7.5–27.5ROR 14.5 · χ² 99 / p 1e-23	12.3 EB05 5.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.4	no trial data cached
Anhedonia	14	13.5 8.0–22.7ROR 13.7 · χ² 150 / p 1e-34	12.3 EB05 7.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	no trial data cached
Economic problem	8	13.2 6.6–26.4ROR 13.4 · χ² 79 / p 4e-19	10.7 EB05 4.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 15.1	no trial data cached
Thyroid disorder	8	13.2 6.6–26.4ROR 13.4 · χ² 79 / p 4e-19	10.7 EB05 4.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.2	no trial data cached
Vaginal haemorrhage	20	12.0 7.8–18.5ROR 12.3 · χ² 191 / p 1e-43	11.1 EB05 7.2 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 14.6	no trial data cached
Application site pain	10	11.6 6.3–21.5ROR 11.7 · χ² 87 / p 7e-21	9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Neoplasm	5	11.1 4.6–26.5ROR 11.1 · χ² 36 / p 8e-10	7.1 EB05 2.9 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Exposure during pregnancy	22	9.0 6.0–13.6ROR 9.2 · χ² 150 / p 1e-34	8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.4 · 71% consumer	no trial data cached
Bone density decreased	11	8.9 4.9–15.9ROR 9.0 · χ² 69 / p 5e-17	7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 9.5	no trial data cached
Emotional distress	36	7.6 5.5–10.4ROR 7.9 · χ² 200 / p 1e-45	7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 86% consumer	no trial data cached
Product quality issue	39	7.4 5.4–10.0ROR 7.7 · χ² 210 / p 6e-48	6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5 · 79% consumer	no trial data cached
Pelvic pain	5	7.0 2.9–16.8ROR 7.0 · χ² 20 / p 4e-6	4.6 EB05 2.1 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Premature baby	7	5.9 2.8–12.4ROR 6.0 · χ² 24 / p 5e-7	4.4 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Chronic kidney disease	68	22.6 18.0–28.4ROR 24.6 · χ² 1,389 / p <1e-300	22.5 EB05 18.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.1	no trial data cached
Product quality issue	39	7.4 5.4–10.0ROR 7.7 · χ² 210 / p 6e-48	6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5 · 79% consumer	no trial data cached
Emotional distress	36	7.6 5.5–10.4ROR 7.9 · χ² 200 / p 1e-45	7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 86% consumer	no trial data cached
Fungal infection	25	19.2 13.0–28.2ROR 19.7 · χ² 413 / p 4e-92	18.9 EB05 13.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 17.6	no trial data cached
Exposure during pregnancy	22	9.0 6.0–13.6ROR 9.2 · χ² 150 / p 1e-34	8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.4 · 71% consumer	no trial data cached
Vaginal haemorrhage	20	12.0 7.8–18.5ROR 12.3 · χ² 191 / p 1e-43	11.1 EB05 7.2 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 14.6	no trial data cached
End stage renal disease	18	25.0 15.8–39.4ROR 25.5 · χ² 390 / p 4e-87	24.3 EB05 16.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.1	no trial data cached
Anhedonia	14	13.5 8.0–22.7ROR 13.7 · χ² 150 / p 1e-34	12.3 EB05 7.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	no trial data cached
Bone density decreased	11	8.9 4.9–15.9ROR 9.0 · χ² 69 / p 5e-17	7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 9.5	no trial data cached
Application site pain	10	11.6 6.3–21.5ROR 11.7 · χ² 87 / p 7e-21	9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Impaired gastric emptying	10	20.0 10.8–37.1ROR 20.3 · χ² 162 / p 2e-37	18.8 EB05 10.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 21.2	no trial data cached
Premature delivery	9	14.4 7.5–27.5ROR 14.5 · χ² 99 / p 1e-23	12.3 EB05 5.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.4	no trial data cached
Thyroid disorder	8	13.2 6.6–26.4ROR 13.4 · χ² 79 / p 4e-19	10.7 EB05 4.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.2	no trial data cached
Economic problem	8	13.2 6.6–26.4ROR 13.4 · χ² 79 / p 4e-19	10.7 EB05 4.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 15.1	no trial data cached
Premature baby	7	5.9 2.8–12.4ROR 6.0 · χ² 24 / p 5e-7	4.4 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached

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.

Chronic kidney disease — n=68, PRR 22.6
Fungal infection — n=25, PRR 19.2
Emotional distress — n=36, PRR 7.6

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 Terconazole?

In FDA FAERS, the most frequently co-reported reaction terms for Terconazole are chronic kidney disease, emotional distress, fungal infection, vaginal haemorrhage, end stage renal disease, anhedonia. 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 Terconazole have an FDA boxed warning?

No. The FDA label retrieved for Terconazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Terconazole 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 38cd1718-6b3c-415d-a17f-7b399adb0ba2, effective 20260507; matched on openfda.generic_name.exact:"TERCONAZOLE")
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, field patient.drug.openfda.generic_name.exact, 27 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

Page generated 2026-10-08. 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.