Choriogonadotropin Alfa side effects: what 2,355 FDA adverse event reports show
Drug class
Gonadotropin
Brand names
Ovidrel
Who reports
2,355 reports · 54% serious · 34 with death outcome · 81% female
Used for
Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer.
What it is
DESCRIPTION Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Chorio.
Boxed warning
None in the current label
Causality screen of the 34 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. 32 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 |
|---|---|---|---|---|---|---|
| Product packaging quantity issue | 83 | 68.2 55.2–84.3ROR 70.7 · χ² 5,391 / p <1e-300 | 66.7 EB05 55.5 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | ♀ 20% (drug 81%) | no trial data cached |
| Poor quality product administered | 39 | 34.1 25.0–46.6ROR 34.7 · χ² 1,216 / p 1e-266 | 33.5 EB05 25.5 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=1 · ♀ 25% (drug 81%) | no trial data cached |
| Ascites | 90 | 27.3 22.3–33.5ROR 28.4 · χ² 2,252 / p <1e-300 | 27.1 EB05 22.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.5 · 94% clinician | no trial data cached |
| Ovarian cyst | 21 | 18.6 12.2–28.5ROR 18.8 · χ² 332 / p 1e-74 | 18.2 EB05 12.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.1 | no trial data cached |
| Abortion spontaneous | 73 | 16.2 12.9–20.3ROR 16.7 · χ² 1,025 / p 4e-225 | 16.1 EB05 13.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 | no trial data cached |
| Product availability issue | 35 | 13.9 10.0–19.3ROR 14.1 · χ² 407 / p 1e-90 | 13.6 EB05 10.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · ♀ 23% (drug 81%) | no trial data cached |
| Abdominal pain lower | 37 | 13.0 9.4–17.9ROR 13.2 · χ² 398 / p 7e-89 | 12.7 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.7 | no trial data cached |
| Abortion induced | 13 | 12.3 7.1–21.1ROR 12.4 · χ² 124 / p 5e-29 | 10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Circumstance or information capable of leading to medication error | 43 | 11.4 8.5–15.4ROR 11.6 · χ² 399 / p 5e-89 | 11.0 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | ♀ 28% (drug 81%) | no trial data cached |
| Incorrect route of product administration | 21 | 11.1 7.3–17.1ROR 11.2 · χ² 184 / p 4e-42 | 10.2 EB05 6.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Drug level decreased | 12 | 10.5 5.9–18.4ROR 10.5 · χ² 93 / p 2e-22 | 8.7 EB05 4.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 | no trial data cached |
| No adverse event | 208 | 10.5 9.2–11.9ROR 11.4 · χ² 1,782 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | ♀ 27% (drug 81%) | no trial data cached |
| Inappropriate schedule of drug administration | 83 | 10.3 8.3–12.7ROR 10.6 · χ² 685 / p 2e-151 | 10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 99% clinician | no trial data cached |
| Product dose omission | 74 | 10.0 8.0–12.5ROR 10.3 · χ² 589 / p 2e-130 | 9.7 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · ♀ 21% (drug 81%) | no trial data cached |
| Pelvic pain | 20 | 9.8 6.3–15.2ROR 9.9 · χ² 149 / p 1e-34 | 8.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.7 | no trial data cached |
| Caesarean section | 12 | 9.1 5.2–16.0ROR 9.1 · χ² 78 / p 4e-19 | 7.4 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Abdominal distension (bloating) | 100 | 8.6 7.1–10.4ROR 8.9 · χ² 664 / p 1e-146 | 8.4 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 | no trial data cached |
| Pleural effusion | 53 | 7.8 5.9–10.1ROR 7.9 · χ² 306 / p 1e-68 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 94% clinician | no trial data cached |
| Drug exposure during pregnancy | 29 | 7.5 5.2–10.8ROR 7.6 · χ² 157 / p 3e-36 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Pregnancy | 15 | 6.6 4.0–10.9ROR 6.6 · χ² 66 / p 2e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.3 | no trial data cached |
| Generalised tonic-clonic seizure | 12 | 6.5 3.7–11.5ROR 6.6 · χ² 51 / p 5e-13 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Maternal exposure during pregnancy | 53 | 5.4 4.1–7.0ROR 5.5 · χ² 184 / p 3e-42 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Needle issue | 17 | 5.3 3.3–8.5ROR 5.3 · χ² 55 / p 6e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Product quality issue | 80 | 5.3 4.3–6.6ROR 5.4 · χ² 275 / p 4e-62 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · ♀ 50% (drug 81%) | no trial data cached |
| Premature baby | 17 | 5.0 3.1–8.1ROR 5.0 · χ² 51 / p 5e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Product physical issue | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 31 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Vaginal haemorrhage | 20 | 4.2 2.7–6.5ROR 4.2 · χ² 45 / p 8e-12 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Product dose omission issue | 110 | 3.4 2.9–4.1ROR 3.6 · χ² 191 / p 1e-43 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · ♀ 20% (drug 81%) | no trial data cached |
| Product storage error | 30 | 3.1 2.2–4.4ROR 3.1 · χ² 40 / p 1e-10 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · ♀ 38% (drug 81%) | no trial data cached |
| Foetal exposure during pregnancy | 25 | 2.7 1.9–4.0ROR 2.8 · χ² 26 / p 2e-7 | 2.6 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.0 · 95% clinician | no trial data cached |
| Injection site reaction | 20 | 2.6 1.7–4.0ROR 2.6 · χ² 18 / p 1e-5 | 2.5 EB05 1.7 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Injection site mass | 10 | 2.4 1.3–4.5ROR 2.4 · χ² 7 / p 0.004 | 2.3 EB05 1.3 · IC025 +0.1 | Labeled (related wording) related wording | – | no trial data cached |
| Injection site pruritus | 18 | 2.4 1.5–3.8ROR 2.4 · χ² 13 / p 1e-4 | 2.3 EB05 1.6 · IC025 +0.4 | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Exposure during pregnancy | 16 | 2.3 1.4–3.7ROR 2.3 · χ² 10 / p 6e-4 | 2.2 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious PRR 3.0 | 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 |
|---|---|---|---|---|---|---|
| No adverse event | 208 | 10.5 9.2–11.9ROR 11.4 · χ² 1,782 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | ♀ 27% (drug 81%) | no trial data cached |
| Product dose omission issue | 110 | 3.4 2.9–4.1ROR 3.6 · χ² 191 / p 1e-43 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · ♀ 20% (drug 81%) | no trial data cached |
| Abdominal distension (bloating) | 100 | 8.6 7.1–10.4ROR 8.9 · χ² 664 / p 1e-146 | 8.4 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 | no trial data cached |
| Ascites | 90 | 27.3 22.3–33.5ROR 28.4 · χ² 2,252 / p <1e-300 | 27.1 EB05 22.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.5 · 94% clinician | no trial data cached |
| Inappropriate schedule of drug administration | 83 | 10.3 8.3–12.7ROR 10.6 · χ² 685 / p 2e-151 | 10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 99% clinician | no trial data cached |
| Product packaging quantity issue | 83 | 68.2 55.2–84.3ROR 70.7 · χ² 5,391 / p <1e-300 | 66.7 EB05 55.5 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | ♀ 20% (drug 81%) | no trial data cached |
| Product quality issue | 80 | 5.3 4.3–6.6ROR 5.4 · χ² 275 / p 4e-62 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · ♀ 50% (drug 81%) | no trial data cached |
| Product dose omission | 74 | 10.0 8.0–12.5ROR 10.3 · χ² 589 / p 2e-130 | 9.7 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · ♀ 21% (drug 81%) | no trial data cached |
| Abortion spontaneous | 73 | 16.2 12.9–20.3ROR 16.7 · χ² 1,025 / p 4e-225 | 16.1 EB05 13.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 | no trial data cached |
| Injection site pain (pain where injected) | 62 | 1.8 1.4–2.3ROR 1.8 · χ² 22 / p 1e-6 | 1.8 EB05 1.5 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 0.6 · ♀ 55% (drug 81%) | no trial data cached |
| Maternal exposure during pregnancy | 53 | 5.4 4.1–7.0ROR 5.5 · χ² 184 / p 3e-42 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Pleural effusion | 53 | 7.8 5.9–10.1ROR 7.9 · χ² 306 / p 1e-68 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 94% clinician | no trial data cached |
| Circumstance or information capable of leading to medication error | 43 | 11.4 8.5–15.4ROR 11.6 · χ² 399 / p 5e-89 | 11.0 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | ♀ 28% (drug 81%) | no trial data cached |
| Poor quality product administered | 39 | 34.1 25.0–46.6ROR 34.7 · χ² 1,216 / p 1e-266 | 33.5 EB05 25.5 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=1 · ♀ 25% (drug 81%) | no trial data cached |
| Abdominal pain lower | 37 | 13.0 9.4–17.9ROR 13.2 · χ² 398 / p 7e-89 | 12.7 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.7 | 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.
- Circumstance or information capable of leading to medication error — n=43, PRR 11.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.
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 Choriogonadotropin Alfa?
In FDA FAERS, the most frequently co-reported reaction terms for Choriogonadotropin Alfa are abdominal distension, ascites, abortion spontaneous, injection site pain, pleural effusion, circumstance or information capable of leading to medication error. 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 Choriogonadotropin Alfa have an FDA boxed warning?
No. The FDA label retrieved for Choriogonadotropin Alfa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Choriogonadotropin Alfa 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 a683e58a-63ea-44b8-a326-1a99a537bcf2, effective 20231226; matched on
openfda.generic_name.exact:"CHORIOGONADOTROPIN ALFA") - 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, 66 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.