Clomiphene Citrtae side effects: what 726 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Clomiphene Citrate
Who reports
726 reports · 63% serious · 34 with death outcome · 58% female
Used for
Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to.
What it is
DESCRIPTION Clomiphene citrate tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy]triethylamine citrate (1:1). It has the molecular formula of C 26 H 28 ClNO.C 6 H 8 O 7 and a molecular weight of 598.08.
Boxed warning
None in the current label
Causality screen of the 19 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Caesarean section | 21 | 51.7 33.9–78.8ROR 53.2 · χ² 992 / p 5e-218 | 49.4 EB05 34.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.4 | no trial data cached |
| Ovarian cyst | 16 | 46.0 28.3–74.7ROR 47.0 · χ² 660 / p 9e-146 | 43.7 EB05 28.5 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 45.9 | no trial data cached |
| Drug exposure during pregnancy | 54 | 45.3 35.0–58.5ROR 48.8 · χ² 2,294 / p <1e-300 | 44.5 EB05 35.4 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 44.2 · ♀ 88% (drug 58%) | no trial data cached |
| Erythema multiforme | 12 | 37.2 21.2–65.3ROR 37.8 · χ² 387 / p 2e-86 | 35.3 EB05 21.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.0 | no trial data cached |
| Pregnancy | 22 | 31.4 20.8–47.5ROR 32.4 · χ² 618 / p 9e-137 | 30.7 EB05 21.3 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.1 · ♀ 100% (drug 58%) | no trial data cached |
| Abortion induced | 10 | 30.7 16.6–56.8ROR 31.1 · χ² 258 / p 2e-58 | 29.0 EB05 16.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 | no trial data cached |
| Deformity | 9 | 27.8 14.5–53.1ROR 28.1 · χ² 206 / p 5e-47 | 26.1 EB05 14.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.0 | no trial data cached |
| Product prescribing issue | 19 | 27.0 17.3–42.1ROR 27.7 · χ² 450 / p 4e-100 | 26.3 EB05 17.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Foot deformity | 9 | 23.4 12.2–44.9ROR 23.7 · χ² 171 / p 2e-39 | 22.0 EB05 11.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 | no trial data cached |
| Nerve injury | 9 | 23.3 12.2–44.7ROR 23.6 · χ² 171 / p 3e-39 | 21.9 EB05 11.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Nodule | 10 | 22.1 12.0–41.0ROR 22.4 · χ² 181 / p 1e-41 | 20.9 EB05 11.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 | no trial data cached |
| Blood iron decreased | 9 | 22.1 11.5–42.2ROR 22.3 · χ² 160 / p 4e-37 | 20.6 EB05 10.7 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 27.4 | no trial data cached |
| Amenorrhoea (missed periods) | 12 | 20.8 11.9–36.4ROR 21.1 · χ² 207 / p 4e-47 | 19.9 EB05 11.6 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 36.1 | no trial data cached |
| Abortion spontaneous | 28 | 20.1 14.0–28.9ROR 20.9 · χ² 490 / p 6e-109 | 19.8 EB05 14.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.8 · ♀ 100% (drug 58%) | no trial data cached |
| Joint range of motion decreased | 9 | 19.5 10.2–37.3ROR 19.7 · χ² 140 / p 2e-32 | 17.9 EB05 8.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 | no trial data cached |
| Exposure during pregnancy | 41 | 19.1 14.2–25.7ROR 20.1 · χ² 685 / p 3e-151 | 18.9 EB05 14.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · ♀ 100% (drug 58%) · 98% clinician | no trial data cached |
| Premature baby | 19 | 18.2 11.7–28.3ROR 18.6 · χ² 292 / p 1e-65 | 17.7 EB05 11.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Drug abuse | 11 | 3.8 2.1–6.8ROR 3.8 · χ² 20 / p 4e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Completed suicide (death by suicide) | 10 | 3.4 1.9–6.4ROR 3.5 · χ² 15 / p 6e-5 | 3.1 EB05 1.8 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 exposure during pregnancy | 54 | 45.3 35.0–58.5ROR 48.8 · χ² 2,294 / p <1e-300 | 44.5 EB05 35.4 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 44.2 · ♀ 88% (drug 58%) | no trial data cached |
| Exposure during pregnancy | 41 | 19.1 14.2–25.7ROR 20.1 · χ² 685 / p 3e-151 | 18.9 EB05 14.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · ♀ 100% (drug 58%) · 98% clinician | no trial data cached |
| Abortion spontaneous | 28 | 20.1 14.0–28.9ROR 20.9 · χ² 490 / p 6e-109 | 19.8 EB05 14.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.8 · ♀ 100% (drug 58%) | no trial data cached |
| Pregnancy | 22 | 31.4 20.8–47.5ROR 32.4 · χ² 618 / p 9e-137 | 30.7 EB05 21.3 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.1 · ♀ 100% (drug 58%) | no trial data cached |
| Caesarean section | 21 | 51.7 33.9–78.8ROR 53.2 · χ² 992 / p 5e-218 | 49.4 EB05 34.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.4 | no trial data cached |
| Premature baby | 19 | 18.2 11.7–28.3ROR 18.6 · χ² 292 / p 1e-65 | 17.7 EB05 11.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Product prescribing issue | 19 | 27.0 17.3–42.1ROR 27.7 · χ² 450 / p 4e-100 | 26.3 EB05 17.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Ovarian cyst | 16 | 46.0 28.3–74.7ROR 47.0 · χ² 660 / p 9e-146 | 43.7 EB05 28.5 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 45.9 | no trial data cached |
| Amenorrhoea (missed periods) | 12 | 20.8 11.9–36.4ROR 21.1 · χ² 207 / p 4e-47 | 19.9 EB05 11.6 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 36.1 | no trial data cached |
| Erythema multiforme | 12 | 37.2 21.2–65.3ROR 37.8 · χ² 387 / p 2e-86 | 35.3 EB05 21.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.0 | no trial data cached |
| Drug abuse | 11 | 3.8 2.1–6.8ROR 3.8 · χ² 20 / p 4e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Completed suicide (death by suicide) | 10 | 3.4 1.9–6.4ROR 3.5 · χ² 15 / p 6e-5 | 3.1 EB05 1.8 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
| Nodule | 10 | 22.1 12.0–41.0ROR 22.4 · χ² 181 / p 1e-41 | 20.9 EB05 11.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 | no trial data cached |
| Abortion induced | 10 | 30.7 16.6–56.8ROR 31.1 · χ² 258 / p 2e-58 | 29.0 EB05 16.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 | no trial data cached |
| Joint range of motion decreased | 9 | 19.5 10.2–37.3ROR 19.7 · χ² 140 / p 2e-32 | 17.9 EB05 8.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 | 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.
- Caesarean section — n=21, PRR 51.7
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 Clomiphene Citrtae?
In FDA FAERS, the most frequently co-reported reaction terms for Clomiphene Citrtae are abortion spontaneous, pregnancy, caesarean section, premature baby, ovarian cyst, amenorrhoea. 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 Clomiphene Citrtae have an FDA boxed warning?
No. The FDA label retrieved for Clomiphene Citrtae has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clomiphene Citrtae 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 086eace1-51db-4d48-976c-9d39ef5be745, effective 20250918; matched on
openfda.generic_name.exact:"CLOMIPHENE CITRTAE") - 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, 28 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.