Clomiphene side effects: what 1,483 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Clomiphene Citrate (Clomid)
Who reports
1,483 reports · 70% serious · 52 with death outcome · 66% 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 Clomid ® (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 CINO • C 6 H 8 O 7 and a molecular weight of 598.10.
Boxed warning
None in the current label
Causality screen of the 27 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.
- 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. 25 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 |
|---|---|---|---|---|---|---|
| Drug exposure during pregnancy | 107 | 44.0 36.6–52.8ROR 47.3 · χ² 4,446 / p <1e-300 | 43.5 EB05 37.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 39.4 | no trial data cached |
| Ovarian cyst | 29 | 40.9 28.5–58.7ROR 41.7 · χ² 1,086 / p 2e-238 | 39.8 EB05 29.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 31.1 · ♀ 100% (drug 66%) | no trial data cached |
| Abortion spontaneous | 110 | 38.8 32.4–46.4ROR 41.8 · χ² 4,005 / p <1e-300 | 38.4 EB05 32.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.8 · ♀ 99% (drug 66%) | no trial data cached |
| Pregnancy | 47 | 32.9 24.8–43.6ROR 34.0 · χ² 1,421 / p <1e-300 | 32.5 EB05 25.4 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 35.4 · ♀ 100% (drug 66%) | no trial data cached |
| Caesarean section | 27 | 32.5 22.4–47.3ROR 33.1 · χ² 793 / p 1e-174 | 31.8 EB05 23.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 · ♀ 88% (drug 66%) | no trial data cached |
| Abortion induced | 16 | 24.0 14.8–39.1ROR 24.3 · χ² 330 / p 4e-74 | 23.4 EB05 15.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Premature baby | 42 | 19.7 14.6–26.5ROR 20.2 · χ² 727 / p 2e-160 | 19.5 EB05 15.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Erythema multiforme | 12 | 18.2 10.4–32.0ROR 18.4 · χ² 178 / p 6e-41 | 17.2 EB05 9.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.5 | no trial data cached |
| Exposure during pregnancy | 74 | 16.8 13.5–21.0ROR 17.7 · χ² 1,089 / p 4e-239 | 16.7 EB05 13.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · ♀ 100% (drug 66%) | no trial data cached |
| Deformity | 11 | 16.6 9.2–29.9ROR 16.7 · χ² 146 / p 6e-34 | 15.3 EB05 8.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 | no trial data cached |
| Nerve injury | 12 | 15.2 8.7–26.8ROR 15.3 · χ² 146 / p 8e-34 | 14.0 EB05 7.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Foot deformity | 11 | 14.0 7.8–25.3ROR 14.1 · χ² 120 / p 3e-28 | 12.4 EB05 6.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Product prescribing issue | 19 | 13.2 8.4–20.7ROR 13.4 · χ² 202 / p 3e-46 | 12.4 EB05 7.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Blood iron decreased | 11 | 13.2 7.3–23.8ROR 13.3 · χ² 112 / p 2e-26 | 11.5 EB05 6.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Nodule | 12 | 13.0 7.4–22.9ROR 13.1 · χ² 121 / p 2e-28 | 11.5 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 | no trial data cached |
| Amenorrhoea (missed periods) | 15 | 12.7 7.7–21.0ROR 12.8 · χ² 150 / p 7e-35 | 11.5 EB05 6.8 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 | no trial data cached |
| Joint range of motion decreased | 12 | 12.7 7.2–22.3ROR 12.8 · χ² 118 / p 9e-28 | 11.1 EB05 6.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Premature delivery | 12 | 10.6 6.0–18.6ROR 10.7 · χ² 95 / p 9e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Erectile dysfunction | 18 | 9.9 6.2–15.7ROR 10.0 · χ² 135 / p 2e-31 | 8.7 EB05 5.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.8 | no trial data cached |
| Maternal exposure during pregnancy | 54 | 8.7 6.7–11.3ROR 9.0 · χ² 360 / p 2e-80 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 87% (drug 66%) | no trial data cached |
| Foetal exposure during pregnancy | 49 | 8.5 6.5–11.2ROR 8.8 · χ² 319 / p 1e-71 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Joint stiffness | 14 | 7.5 4.5–12.7ROR 7.6 · χ² 73 / p 6e-18 | 6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Blood pressure fluctuation | 11 | 6.5 3.6–11.6ROR 6.5 · χ² 46 / p 8e-12 | 5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 | no trial data cached |
| Mood swings | 12 | 5.3 3.0–9.3ROR 5.4 · χ² 38 / p 4e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Hot flush (hot flashes) | 25 | 4.7 3.2–6.9ROR 4.8 · χ² 69 / p 5e-17 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · ♀ 90% (drug 66%) · 79% consumer | no trial data cached |
| Emotional disorder | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Drug abuse | 14 | 2.4 1.4–4.0ROR 2.4 · χ² 10 / p 9e-4 | 2.3 EB05 1.4 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.0 | 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 |
|---|---|---|---|---|---|---|
| Abortion spontaneous | 110 | 38.8 32.4–46.4ROR 41.8 · χ² 4,005 / p <1e-300 | 38.4 EB05 32.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.8 · ♀ 99% (drug 66%) | no trial data cached |
| Drug exposure during pregnancy | 107 | 44.0 36.6–52.8ROR 47.3 · χ² 4,446 / p <1e-300 | 43.5 EB05 37.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 39.4 | no trial data cached |
| Exposure during pregnancy | 74 | 16.8 13.5–21.0ROR 17.7 · χ² 1,089 / p 4e-239 | 16.7 EB05 13.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · ♀ 100% (drug 66%) | no trial data cached |
| Maternal exposure during pregnancy | 54 | 8.7 6.7–11.3ROR 9.0 · χ² 360 / p 2e-80 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 87% (drug 66%) | no trial data cached |
| Foetal exposure during pregnancy | 49 | 8.5 6.5–11.2ROR 8.8 · χ² 319 / p 1e-71 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Pregnancy | 47 | 32.9 24.8–43.6ROR 34.0 · χ² 1,421 / p <1e-300 | 32.5 EB05 25.4 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 35.4 · ♀ 100% (drug 66%) | no trial data cached |
| Premature baby | 42 | 19.7 14.6–26.5ROR 20.2 · χ² 727 / p 2e-160 | 19.5 EB05 15.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Ovarian cyst | 29 | 40.9 28.5–58.7ROR 41.7 · χ² 1,086 / p 2e-238 | 39.8 EB05 29.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 31.1 · ♀ 100% (drug 66%) | no trial data cached |
| Caesarean section | 27 | 32.5 22.4–47.3ROR 33.1 · χ² 793 / p 1e-174 | 31.8 EB05 23.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 · ♀ 88% (drug 66%) | no trial data cached |
| Hot flush (hot flashes) | 25 | 4.7 3.2–6.9ROR 4.8 · χ² 69 / p 5e-17 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · ♀ 90% (drug 66%) · 79% consumer | no trial data cached |
| Product prescribing issue | 19 | 13.2 8.4–20.7ROR 13.4 · χ² 202 / p 3e-46 | 12.4 EB05 7.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Erectile dysfunction | 18 | 9.9 6.2–15.7ROR 10.0 · χ² 135 / p 2e-31 | 8.7 EB05 5.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.8 | no trial data cached |
| Abortion induced | 16 | 24.0 14.8–39.1ROR 24.3 · χ² 330 / p 4e-74 | 23.4 EB05 15.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Amenorrhoea (missed periods) | 15 | 12.7 7.7–21.0ROR 12.8 · χ² 150 / p 7e-35 | 11.5 EB05 6.8 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 | no trial data cached |
| Drug abuse | 14 | 2.4 1.4–4.0ROR 2.4 · χ² 10 / p 9e-4 | 2.3 EB05 1.4 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.0 | 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=27, PRR 32.5
- Premature baby — n=42, PRR 19.7
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?
In FDA FAERS, the most frequently co-reported reaction terms for Clomiphene are abortion spontaneous, pregnancy, premature baby, ovarian cyst, caesarean section, hot flush. 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 have an FDA boxed warning?
No. The FDA label retrieved for Clomiphene has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clomiphene 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 2ca373c1-4dba-4126-8616-5c533d606fe5, effective 20250131; matched on
openfda.generic_name.exact:"CLOMIPHENE CITRATE") - 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, 52 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.