Leuprolide side effects: what 1,480 FDA adverse event reports show
Drug class
Gonadotropin-releasing hormone (gnrh) agonist
Brand names
Camcevi
Who reports
1,480 reports · 72% serious · 125 with death outcome · 42% female
Used for
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
What it is
CAMCEVI is a sterile formulation of leuprolide mesylate for subcutaneous injection. CAMCEVI is designed to deliver approximately 42 mg of leuprolide over 6 months. Leuprolide mesylate is a synthetic nonapeptide analog of naturally occurring GnRH and is a GnRH agonist.
Boxed warning
None in the current label
Causality screen of the 22 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. 30 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 |
|---|---|---|---|---|---|---|
| Prostatic specific antigen increased | 26 | 26.6 18.2–39.0ROR 27.1 · χ² 615 / p 6e-136 | 26.1 EB05 18.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 30.7 · ♀ 0% (drug 42%) | no trial data cached |
| Pneumocystis jirovecii pneumonia | 16 | 22.7 13.9–36.9ROR 22.9 · χ² 310 / p 1e-69 | 22.1 EB05 14.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Metastases to bone | 26 | 22.5 15.4–33.0ROR 22.9 · χ² 513 / p 7e-114 | 22.2 EB05 15.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 | no trial data cached |
| Respiratory depression | 17 | 19.6 12.2–31.5ROR 19.9 · χ² 282 / p 1e-63 | 19.1 EB05 12.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.1 | no trial data cached |
| Breast cancer metastatic | 13 | 17.2 10.0–29.5ROR 17.3 · χ² 182 / p 9e-42 | 16.2 EB05 9.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Hypomagnesaemia | 12 | 12.2 7.0–21.5ROR 12.3 · χ² 113 / p 1e-26 | 10.6 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Obesity | 12 | 10.6 6.1–18.7ROR 10.7 · χ² 95 / p 8e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Metastases to liver | 13 | 10.5 6.1–18.0ROR 10.6 · χ² 102 / p 2e-24 | 8.9 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Febrile neutropenia | 48 | 10.3 7.8–13.6ROR 10.6 · χ² 393 / p 9e-88 | 9.9 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 92% clinician | no trial data cached |
| Product prescribing error | 16 | 9.6 5.9–15.6ROR 9.7 · χ² 114 / p 5e-27 | 8.3 EB05 5.1 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 | no trial data cached |
| Malignant neoplasm progression | 56 | 7.8 6.0–10.1ROR 8.0 · χ² 326 / p 4e-73 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Product storage error | 45 | 7.4 5.5–9.8ROR 7.6 · χ² 242 / p 7e-55 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | ♀ 100% (drug 42%) | no trial data cached |
| Hot flush (hot flashes) | 37 | 6.9 5.1–9.6ROR 7.1 · χ² 183 / p 5e-42 | 6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · ♀ 12% (drug 42%) | no trial data cached |
| Disease progression | 56 | 6.7 5.2–8.7ROR 6.9 · χ² 268 / p 1e-60 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 17% (drug 42%) · 94% clinician | no trial data cached |
| Treatment failure | 34 | 5.9 4.2–8.2ROR 6.0 · χ² 133 / p 5e-31 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · ♀ 9% (drug 42%) · 100% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 17 | 5.8 3.6–9.3ROR 5.8 · χ² 63 / p 1e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 10 | 5.7 3.1–10.5ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Erectile dysfunction | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 32 / p 6e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Abortion spontaneous | 14 | 4.9 2.9–8.3ROR 5.0 · χ² 40 / p 1e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Injection site mass | 10 | 3.8 2.1–7.1ROR 3.9 · χ² 18 / p 1e-5 | 3.3 EB05 2.0 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 1.6 | no trial data cached |
| Prostate cancer | 16 | 2.8 1.7–4.5ROR 2.8 · χ² 17 / p 2e-5 | 2.6 EB05 1.7 · IC025 +0.6 | Likely indication confounding term in indications; also in warnings | serious PRR 2.2 | no trial data cached |
| Drug abuse | 14 | 2.4 1.4–4.0ROR 2.4 · χ² 10 / p 9e-4 | 2.3 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.9 | 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 |
|---|---|---|---|---|---|---|
| Disease progression | 56 | 6.7 5.2–8.7ROR 6.9 · χ² 268 / p 1e-60 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 17% (drug 42%) · 94% clinician | no trial data cached |
| Malignant neoplasm progression | 56 | 7.8 6.0–10.1ROR 8.0 · χ² 326 / p 4e-73 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Febrile neutropenia | 48 | 10.3 7.8–13.6ROR 10.6 · χ² 393 / p 9e-88 | 9.9 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 92% clinician | no trial data cached |
| Product storage error | 45 | 7.4 5.5–9.8ROR 7.6 · χ² 242 / p 7e-55 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | ♀ 100% (drug 42%) | no trial data cached |
| Hot flush (hot flashes) | 37 | 6.9 5.1–9.6ROR 7.1 · χ² 183 / p 5e-42 | 6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · ♀ 12% (drug 42%) | no trial data cached |
| Treatment failure | 34 | 5.9 4.2–8.2ROR 6.0 · χ² 133 / p 5e-31 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · ♀ 9% (drug 42%) · 100% clinician | no trial data cached |
| Metastases to bone | 26 | 22.5 15.4–33.0ROR 22.9 · χ² 513 / p 7e-114 | 22.2 EB05 15.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 | no trial data cached |
| Prostatic specific antigen increased | 26 | 26.6 18.2–39.0ROR 27.1 · χ² 615 / p 6e-136 | 26.1 EB05 18.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 30.7 · ♀ 0% (drug 42%) | no trial data cached |
| Drug dependence | 18 | 1.6 1.0–2.5ROR 1.6 · χ² 3 / p 0.038 | 1.6 EB05 1.0 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 17 | 5.8 3.6–9.3ROR 5.8 · χ² 63 / p 1e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Respiratory depression | 17 | 19.6 12.2–31.5ROR 19.9 · χ² 282 / p 1e-63 | 19.1 EB05 12.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.1 | no trial data cached |
| Prostate cancer | 16 | 2.8 1.7–4.5ROR 2.8 · χ² 17 / p 2e-5 | 2.6 EB05 1.7 · IC025 +0.6 | Likely indication confounding term in indications; also in warnings | serious PRR 2.2 | no trial data cached |
| Product prescribing error | 16 | 9.6 5.9–15.6ROR 9.7 · χ² 114 / p 5e-27 | 8.3 EB05 5.1 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 16 | 22.7 13.9–36.9ROR 22.9 · χ² 310 / p 1e-69 | 22.1 EB05 14.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Injection site erythema (redness where injected) | 14 | 1.6 1.0–2.7ROR 1.6 · χ² 3 / p 0.052 | 1.6 EB05 1.0 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | 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.
- Metastases to bone — n=26, PRR 22.5
- Febrile neutropenia — n=48, PRR 10.3
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 Leuprolide?
In FDA FAERS, the most frequently co-reported reaction terms for Leuprolide are febrile neutropenia, hot flush, metastases to bone, prostatic specific antigen increased, rhabdomyolysis, respiratory depression. 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 Leuprolide have an FDA boxed warning?
No. The FDA label retrieved for Leuprolide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Leuprolide 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 d7a8761a-d953-413a-e053-2a95a90a60ee, effective 20260218; matched on
openfda.generic_name.exact:"LEUPROLIDE") - 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.