Menotropins side effects: what 2,088 FDA adverse event reports show
Drug class
Gonadotropin
Brand names
Menopur
Who reports
2,088 reports · 49% serious · 32 with death outcome · 99% female
Used for
MENOPUR ® (menotropins for injection) is a gonadotropin indicated for: Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle ( 1 ) Development of Multiple Follicles and Pregnancy i.
What it is
MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, .
Boxed warning
None in the current label
Causality screen of the 26 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.
- 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. 28 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 |
|---|---|---|---|---|---|---|
| Ascites | 94 | 32.2 26.4–39.2ROR 33.7 · χ² 2,805 / p <1e-300 | 31.9 EB05 26.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.6 · 96% clinician | no trial data cached |
| Abdominal distension (bloating) | 182 | 17.6 15.3–20.2ROR 19.2 · χ² 2,844 / p <1e-300 | 17.5 EB05 15.5 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.1 | no trial data cached |
| Abortion spontaneous | 67 | 16.7 13.2–21.2ROR 17.3 · χ² 977 / p 1e-214 | 16.6 EB05 13.5 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.4 | no trial data cached |
| Ovarian cyst | 15 | 15.0 9.1–24.8ROR 15.1 · χ² 182 / p 9e-42 | 14.1 EB05 8.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.4 | no trial data cached |
| Caesarean section | 17 | 14.5 9.0–23.3ROR 14.6 · χ² 201 / p 7e-46 | 13.7 EB05 8.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Drug exposure during pregnancy | 45 | 13.1 9.8–17.5ROR 13.4 · χ² 492 / p 3e-109 | 12.8 EB05 9.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 | no trial data cached |
| Pregnancy | 26 | 12.9 8.8–18.9ROR 13.1 · χ² 274 / p 7e-62 | 12.4 EB05 8.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 19.8 | no trial data cached |
| Inappropriate schedule of drug administration | 81 | 11.3 9.1–14.0ROR 11.7 · χ² 751 / p 1e-165 | 11.1 EB05 9.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 99% clinician | no trial data cached |
| Abortion induced | 10 | 10.7 5.7–19.8ROR 10.7 · χ² 78 / p 5e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.2 | no trial data cached |
| Drug level decreased | 10 | 9.8 5.3–18.2ROR 9.9 · χ² 71 / p 2e-17 | 7.8 EB05 4.2 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 14.4 | no trial data cached |
| Generalised tonic-clonic seizure | 11 | 6.8 3.7–12.2ROR 6.8 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Abdominal pain lower | 17 | 6.7 4.2–10.8ROR 6.8 · χ² 77 / p 7e-19 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 | no trial data cached |
| Needle issue | 15 | 5.3 3.2–8.7ROR 5.3 · χ² 48 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Maternal exposure during pregnancy | 46 | 5.2 3.9–7.0ROR 5.3 · χ² 154 / p 1e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Cerebral infarction | 12 | 4.9 2.8–8.7ROR 5.0 · χ² 34 / p 3e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Premature baby | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 7e-10 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Injection site rash | 14 | 4.6 2.7–7.8ROR 4.7 · χ² 36 / p 8e-10 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Injection site pain (pain where injected) | 139 | 4.6 3.9–5.4ROR 4.9 · χ² 394 / p 7e-88 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Chest discomfort | 44 | 4.3 3.2–5.8ROR 4.4 · χ² 110 / p 5e-26 | 4.2 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 98% clinician | no trial data cached |
| Injection site bruising | 32 | 4.1 2.9–5.7ROR 4.1 · χ² 71 / p 1e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 0.9 | no trial data cached |
| Injection site pruritus | 26 | 3.9 2.7–5.8ROR 4.0 · χ² 54 / p 1e-13 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 | no trial data cached |
| Injection site mass | 14 | 3.8 2.3–6.4ROR 3.8 · χ² 26 / p 1e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.7 | no trial data cached |
| Vaginal haemorrhage | 16 | 3.8 2.3–6.2ROR 3.8 · χ² 30 / p 2e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Injection site reaction | 20 | 2.9 1.9–4.5ROR 2.9 · χ² 24 / p 6e-7 | 2.8 EB05 1.9 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Exposure during pregnancy | 18 | 2.9 1.8–4.6ROR 2.9 · χ² 21 / p 3e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Injection site erythema (redness where injected) | 33 | 2.7 1.9–3.8ROR 2.7 · χ² 33 / p 4e-9 | 2.6 EB05 2.0 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 2.4 | 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 |
|---|---|---|---|---|---|---|
| Abdominal distension (bloating) | 182 | 17.6 15.3–20.2ROR 19.2 · χ² 2,844 / p <1e-300 | 17.5 EB05 15.5 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.1 | no trial data cached |
| Injection site pain (pain where injected) | 139 | 4.6 3.9–5.4ROR 4.9 · χ² 394 / p 7e-88 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Ascites | 94 | 32.2 26.4–39.2ROR 33.7 · χ² 2,805 / p <1e-300 | 31.9 EB05 26.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.6 · 96% clinician | no trial data cached |
| Inappropriate schedule of drug administration | 81 | 11.3 9.1–14.0ROR 11.7 · χ² 751 / p 1e-165 | 11.1 EB05 9.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 99% clinician | no trial data cached |
| Abortion spontaneous | 67 | 16.7 13.2–21.2ROR 17.3 · χ² 977 / p 1e-214 | 16.6 EB05 13.5 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.4 | no trial data cached |
| Maternal exposure during pregnancy | 46 | 5.2 3.9–7.0ROR 5.3 · χ² 154 / p 1e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Drug exposure during pregnancy | 45 | 13.1 9.8–17.5ROR 13.4 · χ² 492 / p 3e-109 | 12.8 EB05 9.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 | no trial data cached |
| Chest discomfort | 44 | 4.3 3.2–5.8ROR 4.4 · χ² 110 / p 5e-26 | 4.2 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 98% clinician | no trial data cached |
| Injection site erythema (redness where injected) | 33 | 2.7 1.9–3.8ROR 2.7 · χ² 33 / p 4e-9 | 2.6 EB05 2.0 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Injection site bruising | 32 | 4.1 2.9–5.7ROR 4.1 · χ² 71 / p 1e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 0.9 | no trial data cached |
| Injection site pruritus | 26 | 3.9 2.7–5.8ROR 4.0 · χ² 54 / p 1e-13 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 | no trial data cached |
| Pregnancy | 26 | 12.9 8.8–18.9ROR 13.1 · χ² 274 / p 7e-62 | 12.4 EB05 8.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 19.8 | no trial data cached |
| Injection site reaction | 20 | 2.9 1.9–4.5ROR 2.9 · χ² 24 / p 6e-7 | 2.8 EB05 1.9 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Exposure during pregnancy | 18 | 2.9 1.8–4.6ROR 2.9 · χ² 21 / p 3e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Abdominal pain lower | 17 | 6.7 4.2–10.8ROR 6.8 · χ² 77 / p 7e-19 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 | 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.
- Chest discomfort — n=44, PRR 4.3
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 Menotropins?
In FDA FAERS, the most frequently co-reported reaction terms for Menotropins are abdominal distension, injection site pain, ascites, abortion spontaneous, chest discomfort, injection site erythema. 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 Menotropins have an FDA boxed warning?
No. The FDA label retrieved for Menotropins has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Menotropins 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 22c8db95-c3db-1770-8086-31356fbabe35, effective 20180531; matched on
openfda.generic_name.exact:"MENOTROPINS") - 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, 54 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.