Drug · FAERS side-effect profile with label screen

Cetrorelix side effects: what 617 FDA adverse event reports show

Cetrorelix Acetate · 22 reaction terms · 238 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Cetrorelix Acetate (Cetrorelix Acetate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

617 reports · 71% serious · 7 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

FDA label, Indications and Usage

What it is

DESCRIPTION Cetrorelix acetate for injection is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10.

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 17 strongest signals

Labeled adverse reaction 1Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 9

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. 5 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
Drug level decreased	17	56.6 35.4–90.4ROR 58.2 · χ² 872 / p 5e-192	53.3 EB05 35.2 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 57.0	no trial data cached
Generalised tonic-clonic seizure	18	37.4 23.7–59.0ROR 38.5 · χ² 602 / p 3e-133	36.1 EB05 24.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Abortion spontaneous	39	33.0 24.3–44.7ROR 35.1 · χ² 1,178 / p 1e-258	32.5 EB05 24.8 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.7	no trial data cached
Ascites	28	32.4 22.5–46.5ROR 33.9 · χ² 821 / p 8e-181	31.7 EB05 23.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.8 · 96% clinician	no trial data cached
Caesarean section	8	23.1 11.6–46.1ROR 23.4 · χ² 148 / p 2e-34	21.4 EB05 10.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 19.4	no trial data cached
Pregnancy	10	16.8 9.1–31.1ROR 17.1 · χ² 133 / p 4e-31	15.3 EB05 7.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.1	no trial data cached
Injection site urticaria	11	15.4 8.6–27.7ROR 15.7 · χ² 134 / p 2e-31	14.0 EB05 7.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Pelvic pain	8	15.0 7.5–29.8ROR 15.1 · χ² 91 / p 8e-22	12.6 EB05 5.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Drug exposure during pregnancy	11	10.8 6.0–19.5ROR 11.0 · χ² 89 / p 2e-21	8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Mania	5	10.3 4.3–24.8ROR 10.4 · χ² 33 / p 4e-9	6.6 EB05 2.7 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Injection site rash	9	10.1 5.3–19.3ROR 10.2 · χ² 65 / p 4e-16	7.8 EB05 4.0 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Injury associated with device	5	8.4 3.5–20.2ROR 8.5 · χ² 26 / p 2e-7	5.4 EB05 2.4 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Injection site pruritus	14	7.2 4.3–12.0ROR 7.3 · χ² 68 / p 7e-17	6.0 EB05 3.7 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.6	no trial data cached
Needle issue	6	7.1 3.2–15.8ROR 7.2 · χ² 26 / p 2e-7	5.0 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Premature baby	6	6.8 3.0–15.0ROR 6.8 · χ² 24 / p 5e-7	4.7 EB05 2.3 · IC025 +0.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 5.6	no trial data cached
Injection site swelling	10	4.5 2.4–8.3ROR 4.5 · χ² 24 / p 5e-7	3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.6	no trial data cached
Injection site erythema (redness where injected)	16	4.4 2.7–7.1ROR 4.5 · χ² 39 / p 2e-10	4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.5	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
Abortion spontaneous	39	33.0 24.3–44.7ROR 35.1 · χ² 1,178 / p 1e-258	32.5 EB05 24.8 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.7	no trial data cached
Ascites	28	32.4 22.5–46.5ROR 33.9 · χ² 821 / p 8e-181	31.7 EB05 23.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.8 · 96% clinician	no trial data cached
Generalised tonic-clonic seizure	18	37.4 23.7–59.0ROR 38.5 · χ² 602 / p 3e-133	36.1 EB05 24.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Drug level decreased	17	56.6 35.4–90.4ROR 58.2 · χ² 872 / p 5e-192	53.3 EB05 35.2 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 57.0	no trial data cached
Injection site erythema (redness where injected)	16	4.4 2.7–7.1ROR 4.5 · χ² 39 / p 2e-10	4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.5	no trial data cached
Injection site pruritus	14	7.2 4.3–12.0ROR 7.3 · χ² 68 / p 7e-17	6.0 EB05 3.7 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.6	no trial data cached
Drug exposure during pregnancy	11	10.8 6.0–19.5ROR 11.0 · χ² 89 / p 2e-21	8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Injection site urticaria	11	15.4 8.6–27.7ROR 15.7 · χ² 134 / p 2e-31	14.0 EB05 7.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Injection site swelling	10	4.5 2.4–8.3ROR 4.5 · χ² 24 / p 5e-7	3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.6	no trial data cached
Pregnancy	10	16.8 9.1–31.1ROR 17.1 · χ² 133 / p 4e-31	15.3 EB05 7.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.1	no trial data cached
Injection site rash	9	10.1 5.3–19.3ROR 10.2 · χ² 65 / p 4e-16	7.8 EB05 4.0 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Pelvic pain	8	15.0 7.5–29.8ROR 15.1 · χ² 91 / p 8e-22	12.6 EB05 5.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Caesarean section	8	23.1 11.6–46.1ROR 23.4 · χ² 148 / p 2e-34	21.4 EB05 10.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 19.4	no trial data cached
Premature baby	6	6.8 3.0–15.0ROR 6.8 · χ² 24 / p 5e-7	4.7 EB05 2.3 · IC025 +0.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 5.6	no trial data cached
Needle issue	6	7.1 3.2–15.8ROR 7.2 · χ² 26 / p 2e-7	5.0 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	–	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.

Ascites — n=28, PRR 32.4

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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 Cetrorelix?

In FDA FAERS, the most frequently co-reported reaction terms for Cetrorelix are abortion spontaneous, ascites, generalised tonic-clonic seizure, injection site erythema, injection site pruritus, injection site urticaria. 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 Cetrorelix have an FDA boxed warning?

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

Do FAERS signals prove that Cetrorelix 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 89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a, effective 20240808; matched on openfda.generic_name.exact:"CETRORELIX ACETATE")
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, 22 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.