Drug · FAERS side-effect profile with label screen
Goserelin side effects: what 13,348 FDA adverse event reports show
Drug class
Gonadotropin releasing hormone (gnrh) agonist
FDA label, Indications wording
Brand names
Zoladex
openFDA label
Who reports
13,348 reports · 90% serious · 2,403 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Palliative treatment of advanced carcinoma of the prostate ( 1.2 ) The .
FDA label, Indications and Usage
What it is
ZOLADEX (goserelin implant) is a GnRH agonist. Goserelin acetate is chemically described as an acetate salt of [D-Ser(Bu t ) 6 ,Azgly 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 40 strongest signals
Labeled (related wording) 6Likely indication confounding 4Lab value / disease marker 4Not in label — unassessed 26
What the badges mean
- 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.
- 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. 1,061 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cyp3a4 polymorphism | 10 | 7,746.2 1,697.4–35,350.8ROR 7,752.0 · χ² 11,648 / p <1e-300 | 371.6 EB05 215.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Central nervous system mass | 51 | 1,927.1 1,277.9–2,906.1ROR 1,934.5 · χ² 42,900 / p <1e-300 | 648.8 EB05 512.6 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=51 · ♀ 0% (drug 46%) | no trial data cached |
| Malignant spinal cord compression | 22 | 1,704.2 930.3–3,121.8ROR 1,707.0 · χ² 17,030 / p <1e-300 | 475.0 EB05 330.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 0% (drug 46%) | no trial data cached |
| Wall motion score index abnormal | 51 | 1,362.3 935.5–1,983.8ROR 1,367.5 · χ² 36,193 / p <1e-300 | 569.4 EB05 449.9 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=51 · ♀ 0% (drug 46%) | no trial data cached |
| Airway remodelling | 51 | 1,097.4 766.9–1,570.3ROR 1,101.6 · χ² 32,062 / p <1e-300 | 517.4 EB05 408.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 46%) | no trial data cached |
| Mucinous breast carcinoma | 11 | 631.2 313.2–1,272.1ROR 631.7 · χ² 4,480 / p <1e-300 | 252.4 EB05 150.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Atopy | 51 | 352.7 260.4–477.9ROR 354.1 · χ² 14,285 / p <1e-300 | 259.6 EB05 205.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 46%) | no trial data cached |
| Pik3ca-activated mutation | 55 | 319.1 238.9–426.4ROR 320.4 · χ² 14,201 / p <1e-300 | 242.5 EB05 193.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 46%) | no trial data cached |
| Expulsion of medication | 70 | 257.0 199.7–330.8ROR 258.3 · χ² 15,091 / p <1e-300 | 208.1 EB05 170.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | 90% clinician | no trial data cached |
| Ultrasound foetal abnormal | 11 | 236.7 125.5–446.3ROR 236.9 · χ² 2,040 / p <1e-300 | 151.9 EB05 90.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Metastases to spinal cord | 23 | 210.8 136.4–325.8ROR 211.2 · χ² 4,045 / p <1e-300 | 161.1 EB05 113.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=23 | no trial data cached |
| Metastases to nervous system | 17 | 163.6 99.3–269.6ROR 163.8 · χ² 2,340 / p <1e-300 | 127.2 EB05 84.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Pleural neoplasm | 13 | 134.3 76.2–236.6ROR 134.4 · χ² 1,462 / p <1e-300 | 105.0 EB05 65.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Oophorectomy bilateral | 12 | 130.9 72.6–235.9ROR 131.0 · χ² 1,309 / p 6e-287 | 101.7 EB05 62.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Eosinophilic myocarditis | 51 | 117.9 88.8–156.7ROR 118.4 · χ² 5,387 / p <1e-300 | 105.4 EB05 83.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 46%) | no trial data cached |
| Carbohydrate antigen 15-3 increased | 52 | 115.1 86.9–152.5ROR 115.5 · χ² 5,369 / p <1e-300 | 103.2 EB05 81.8 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=51 · ♀ 100% (drug 46%) | no trial data cached |
| Cardiac septal defect | 49 | 114.0 85.3–152.3ROR 114.4 · χ² 5,007 / p <1e-300 | 102.1 EB05 80.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 0% (drug 46%) | no trial data cached |
| Metastases to ovary | 19 | 100.1 63.0–159.2ROR 100.3 · χ² 1,659 / p <1e-300 | 86.2 EB05 58.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Microangiopathy | 51 | 90.6 68.4–120.1ROR 91.0 · χ² 4,186 / p <1e-300 | 83.1 EB05 65.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 46%) | no trial data cached |
| Carcinoid tumour pulmonary | 13 | 89.1 51.0–155.8ROR 89.2 · χ² 989 / p 2e-217 | 75.3 EB05 46.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Metastases to the mediastinum | 22 | 87.8 57.2–134.9ROR 88.0 · χ² 1,706 / p <1e-300 | 77.8 EB05 54.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Metastases to pelvis | 32 | 83.9 58.8–119.7ROR 84.1 · χ² 2,408 / p <1e-300 | 76.1 EB05 56.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 81% (drug 46%) | no trial data cached |
| Hormone receptor positive breast cancer | 13 | 81.5 46.7–142.4ROR 81.6 · χ² 907 / p 1e-199 | 69.9 EB05 43.5 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Metastases to skin | 49 | 78.9 59.3–105.1ROR 79.2 · χ² 3,513 / p <1e-300 | 73.1 EB05 57.5 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=49 · ♀ 100% (drug 46%) | no trial data cached |
| Invasive lobular breast carcinoma | 23 | 73.8 48.6–112.1ROR 73.9 · χ² 1,507 / p <1e-300 | 66.7 EB05 46.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Oestradiol increased | 13 | 71.4 41.0–124.5ROR 71.5 · χ² 797 / p 1e-175 | 62.4 EB05 38.8 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Oestradiol decreased | 14 | 71.1 41.6–121.5ROR 71.2 · χ² 859 / p 3e-189 | 62.5 EB05 39.6 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Metastases to bone | 698 | 70.0 65.0–75.4ROR 73.8 · χ² 45,395 / p <1e-300 | 66.9 EB05 62.8 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 43.1 · ♀ 71% (drug 46%) | no trial data cached |
| Dilatation intrahepatic duct acquired | 12 | 67.9 38.1–120.9ROR 67.9 · χ² 694 / p 2e-153 | 59.2 EB05 36.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hormone receptor positive her2 negative breast cancer | 13 | 67.8 38.9–118.1ROR 67.9 · χ² 757 / p 6e-167 | 59.6 EB05 37.1 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Invasive breast carcinoma | 17 | 67.4 41.5–109.4ROR 67.4 · χ² 1,002 / p 3e-220 | 60.4 EB05 40.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Adnexa uteri mass | 11 | 64.3 35.2–117.5ROR 64.4 · χ² 599 / p 2e-132 | 56.1 EB05 33.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Metastases to spine | 127 | 61.9 51.8–73.8ROR 62.4 · χ² 7,254 / p <1e-300 | 59.0 EB05 50.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=126 · ♀ 70% (drug 46%) | no trial data cached |
| Abdominal lymphadenopathy | 30 | 56.9 39.5–81.9ROR 57.0 · χ² 1,535 / p <1e-300 | 53.2 EB05 39.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 88% (drug 46%) · 100% clinician | no trial data cached |
| Prostate cancer metastatic | 114 | 55.3 45.9–66.6ROR 55.8 · χ² 5,817 / p <1e-300 | 53.0 EB05 45.3 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=115 · ♀ 0% (drug 46%) | no trial data cached |
| Bone marrow infiltration | 13 | 54.7 31.5–95.1ROR 54.8 · χ² 611 / p 3e-135 | 49.3 EB05 30.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Metastases to pleura | 34 | 53.0 37.7–74.6ROR 53.1 · χ² 1,627 / p <1e-300 | 49.9 EB05 37.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 46%) · 100% clinician | no trial data cached |
| Pituitary haemorrhage | 10 | 51.6 27.5–96.9ROR 51.7 · χ² 433 / p 2e-96 | 45.9 EB05 26.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Fibrous histiocytoma | 10 | 45.4 24.2–85.2ROR 45.5 · χ² 380 / p 6e-85 | 41.0 EB05 23.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Prostate cancer recurrent | 17 | 44.7 27.6–72.4ROR 44.8 · χ² 664 / p 9e-147 | 41.6 EB05 27.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | 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 |
|---|---|---|---|---|---|---|
| Death | 1,587 | 2.9 2.8–3.0ROR 3.2 · χ² 2,052 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.9 · ♀ 14% (drug 46%) | no trial data cached |
| Malignant neoplasm progression | 1,340 | 20.9 19.9–22.0ROR 23.2 · χ² 25,195 / p <1e-300 | 20.7 EB05 19.7 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.5 | no trial data cached |
| Fatigue (tiredness) | 886 | 1.8 1.7–1.9ROR 1.8 · χ² 321 / p 4e-72 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 · ♀ 67% (drug 46%) | no trial data cached |
| Metastases to bone | 698 | 70.0 65.0–75.4ROR 73.8 · χ² 45,395 / p <1e-300 | 66.9 EB05 62.8 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 43.1 · ♀ 71% (drug 46%) | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 656 | 7.6 7.1–8.2ROR 8.0 · χ² 3,784 / p <1e-300 | 7.6 EB05 7.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 88% (drug 46%) | no trial data cached |
| Nausea | 600 | 1.2 1.1–1.3ROR 1.2 · χ² 20 / p 5e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 · ♀ 67% (drug 46%) | no trial data cached |
| Hot flush (hot flashes) | 523 | 11.0 10.1–11.9ROR 11.4 · χ² 4,712 / p <1e-300 | 10.9 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.8 | no trial data cached |
| Asthenia (weakness) | 515 | 2.2 2.0–2.3ROR 2.2 · χ² 322 / p 2e-72 | 2.1 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Diarrhoea (diarrhea) | 496 | 1.2 1.1–1.3ROR 1.2 · χ² 19 / p 8e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.2 · ♀ 72% (drug 46%) | no trial data cached |
| Pain | 480 | 1.2 1.1–1.3ROR 1.2 · χ² 20 / p 3e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Likely indication confounding term in indications; also in warnings | serious PRR 1.1 | no trial data cached |
| Off label use (used outside approved label) | 474 | 0.9 0.8–0.9ROR 0.9 · χ² 11 / p 4e-4 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Metastases to liver | 445 | 40.9 37.3–44.9ROR 42.3 · χ² 16,847 / p <1e-300 | 39.8 EB05 36.8 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.6 · ♀ 89% (drug 46%) | no trial data cached |
| Dyspnoea (shortness of breath) | 441 | 1.2 1.1–1.3ROR 1.2 · χ² 18 / p 8e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Arthralgia (joint pain) | 436 | 1.7 1.5–1.8ROR 1.7 · χ² 114 / p 6e-27 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 · ♀ 72% (drug 46%) | no trial data cached |
| Headache | 408 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.325 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 · ♀ 76% (drug 46%) | 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.
- Malignant spinal cord compression — n=22, PRR 1,704.2
- Airway remodelling — n=51, PRR 1,097.4
- Atopy — n=51, PRR 352.7
- Pik3ca-activated mutation — n=55, PRR 319.1
- Expulsion of medication — n=70, PRR 257.0
- Eosinophilic myocarditis — n=51, PRR 117.9
- Cardiac septal defect — n=49, PRR 114.0
- Microangiopathy — n=51, PRR 90.6
- Metastases to the mediastinum — n=22, PRR 87.8
- Metastases to pelvis — n=32, PRR 83.9
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 Goserelin?
In FDA FAERS, the most frequently co-reported reaction terms for Goserelin are fatigue, metastases to bone, neutropenia, nausea, hot flush, asthenia. 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 Goserelin have an FDA boxed warning?
No. The FDA label retrieved for Goserelin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Goserelin 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 294b168b-6e5f-4db9-bf70-d599271458b3, effective 20260324; matched on
openfda.generic_name.exact:"GOSERELIN") - 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, 1,101 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.