Drug · FAERS side-effect profile with label screen
Triptorelin side effects: what 3,297 FDA adverse event reports show
Drug class
Gonadotropin releasing hormone (gnrh) agonist
FDA label, Indications wording
Brand names
Triptodur
openFDA label
Who reports
3,297 reports · 64% serious · 192 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty. ( 1 )
FDA label, Indications and Usage
What it is
TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH).
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 adverse reaction 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 8Lab value / disease marker 1Not in label — unassessed 24
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. 62 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 |
|---|---|---|---|---|---|---|
| Needle issue | 197 | 44.1 38.5–50.5ROR 46.8 · χ² 8,209 / p <1e-300 | 43.6 EB05 38.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=14 · ♀ 81% (drug 58%) | no trial data cached |
| Syringe issue | 90 | 32.8 26.8–40.3ROR 33.7 · χ² 2,733 / p <1e-300 | 32.5 EB05 27.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Affect lability | 39 | 25.8 18.8–35.2ROR 26.0 · χ² 900 / p 5e-198 | 25.4 EB05 19.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · ♀ 87% (drug 58%) · 87% consumer | no trial data cached |
| Product use complaint | 51 | 21.0 16.0–27.6ROR 21.3 · χ² 949 / p 1e-208 | 20.8 EB05 16.4 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=5 · ♀ 88% (drug 58%) | no trial data cached |
| Product administration error | 58 | 18.5 14.4–23.9ROR 18.8 · χ² 943 / p 3e-207 | 18.4 EB05 14.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · ♀ 81% (drug 58%) | no trial data cached |
| Mood altered | 78 | 18.3 14.7–22.8ROR 18.7 · χ² 1,257 / p 2e-275 | 18.2 EB05 15.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · ♀ 90% (drug 58%) · 81% consumer | no trial data cached |
| Prostatic specific antigen increased | 37 | 17.0 12.4–23.5ROR 17.2 · χ² 541 / p 5e-120 | 16.8 EB05 12.6 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 24.5 · ♀ 0% (drug 58%) | no trial data cached |
| Vaginal haemorrhage | 94 | 14.1 11.5–17.2ROR 14.5 · χ² 1,128 / p 1e-247 | 14.0 EB05 11.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 100% (drug 58%) · 82% consumer | no trial data cached |
| Metastases to bone | 31 | 12.1 8.5–17.1ROR 12.2 · χ² 303 / p 3e-68 | 11.6 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Product physical issue | 37 | 11.8 8.6–16.3ROR 11.9 · χ² 356 / p 1e-79 | 11.4 EB05 8.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=2 · ♀ 79% (drug 58%) | no trial data cached |
| Mood swings | 55 | 11.0 8.4–14.3ROR 11.2 · χ² 489 / p 1e-108 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 81% (drug 58%) · 82% consumer | no trial data cached |
| Product prescribing issue | 33 | 10.3 7.4–14.5ROR 10.4 · χ² 269 / p 1e-60 | 9.7 EB05 7.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Increased appetite | 25 | 8.5 5.7–12.5ROR 8.5 · χ² 157 / p 2e-36 | 7.6 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 84% (drug 58%) · 92% consumer | no trial data cached |
| Erectile dysfunction | 31 | 7.7 5.4–10.9ROR 7.7 · χ² 173 / p 8e-40 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 0% (drug 58%) | no trial data cached |
| Abortion spontaneous | 48 | 7.6 5.7–10.1ROR 7.7 · χ² 269 / p 1e-60 | 7.2 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · ♀ 100% (drug 58%) · 100% clinician | no trial data cached |
| Personality change | 11 | 7.5 4.2–13.5ROR 7.5 · χ² 55 / p 5e-14 | 6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Dysmenorrhoea | 15 | 7.3 4.4–12.1ROR 7.3 · χ² 75 / p 2e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Disease progression | 133 | 7.2 6.1–8.5ROR 7.4 · χ² 704 / p 2e-155 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · ♀ 85% (drug 58%) | no trial data cached |
| Hot flush (hot flashes) | 78 | 6.6 5.3–8.2ROR 6.7 · χ² 365 / p 1e-81 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 43 | 6.6 4.9–8.9ROR 6.6 · χ² 198 / p 3e-45 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 0% (drug 58%) · 100% clinician | no trial data cached |
| Vaginal discharge | 10 | 6.3 3.4–11.8ROR 6.4 · χ² 40 / p 1e-10 | 5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Ascites | 29 | 6.3 4.4–9.0ROR 6.3 · χ² 123 / p 6e-29 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 96% (drug 58%) · 96% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 10 | 6.3 3.4–11.6ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.7 | no trial data cached |
| Incorrect route of product administration | 16 | 6.1 3.7–9.9ROR 6.1 · χ² 63 / p 1e-15 | 5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 | no trial data cached |
| Metastases to liver | 16 | 5.8 3.6–9.5ROR 5.8 · χ² 59 / p 8e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Emotional disorder | 28 | 5.7 4.0–8.3ROR 5.8 · χ² 105 / p 6e-25 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.4 · 79% consumer | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 22 | 5.6 3.7–8.5ROR 5.6 · χ² 79 / p 3e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 100% clinician | no trial data cached |
| Cytopenia | 10 | 5.3 2.9–9.9ROR 5.3 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Crying | 29 | 5.1 3.5–7.3ROR 5.1 · χ² 91 / p 9e-22 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.8 · ♀ 86% (drug 58%) · 79% consumer | no trial data cached |
| Hypocalcaemia (low calcium) | 15 | 5.1 3.1–8.4ROR 5.1 · χ² 45 / p 1e-11 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Acne | 60 | 5.0 3.9–6.4ROR 5.1 · χ² 189 / p 2e-43 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 87% (drug 58%) · 85% consumer | no trial data cached |
| Osteopenia | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Malignant neoplasm progression | 75 | 4.7 3.7–5.9ROR 4.8 · χ² 215 / p 7e-49 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Cholestasis (bile flow blockage) | 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 4.3 | no trial data cached |
| Haematuria (blood in urine) | 24 | 4.5 3.0–6.6ROR 4.5 · χ² 61 / p 3e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 5% (drug 58%) · 100% clinician | no trial data cached |
| Hepatic failure | 20 | 4.2 2.7–6.5ROR 4.2 · χ² 46 / p 6e-12 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 95% clinician | no trial data cached |
| Aggression | 32 | 4.1 2.9–5.7ROR 4.1 · χ² 71 / p 2e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Pelvic pain | 11 | 3.8 2.1–6.9ROR 3.9 · χ² 20 / p 3e-6 | 3.4 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Ischaemic stroke | 10 | 3.6 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Disease recurrence | 25 | 3.3 2.3–4.9ROR 3.4 · χ² 39 / p 3e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · ♀ 100% (drug 58%) | 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 |
|---|---|---|---|---|---|---|
| Needle issue | 197 | 44.1 38.5–50.5ROR 46.8 · χ² 8,209 / p <1e-300 | 43.6 EB05 38.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=14 · ♀ 81% (drug 58%) | no trial data cached |
| Disease progression | 133 | 7.2 6.1–8.5ROR 7.4 · χ² 704 / p 2e-155 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · ♀ 85% (drug 58%) | no trial data cached |
| Product dose omission issue | 122 | 2.7 2.3–3.2ROR 2.8 · χ² 133 / p 4e-31 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Injection site pain (pain where injected) | 102 | 2.1 1.8–2.6ROR 2.2 · χ² 61 / p 2e-15 | 2.1 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 3.0 · ♀ 82% (drug 58%) · 74% consumer | no trial data cached |
| Weight increased (weight gain) | 102 | 2.9 2.4–3.5ROR 3.0 · χ² 128 / p 7e-30 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · ♀ 86% (drug 58%) · 73% consumer | no trial data cached |
| Vaginal haemorrhage | 94 | 14.1 11.5–17.2ROR 14.5 · χ² 1,128 / p 1e-247 | 14.0 EB05 11.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 100% (drug 58%) · 82% consumer | no trial data cached |
| Syringe issue | 90 | 32.8 26.8–40.3ROR 33.7 · χ² 2,733 / p <1e-300 | 32.5 EB05 27.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Incorrect dose administered | 78 | 2.2 1.8–2.7ROR 2.2 · χ² 51 / p 5e-13 | 2.2 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Hot flush (hot flashes) | 78 | 6.6 5.3–8.2ROR 6.7 · χ² 365 / p 1e-81 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 | no trial data cached |
| Mood altered | 78 | 18.3 14.7–22.8ROR 18.7 · χ² 1,257 / p 2e-275 | 18.2 EB05 15.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · ♀ 90% (drug 58%) · 81% consumer | no trial data cached |
| Malignant neoplasm progression | 75 | 4.7 3.7–5.9ROR 4.8 · χ² 215 / p 7e-49 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Acne | 60 | 5.0 3.9–6.4ROR 5.1 · χ² 189 / p 2e-43 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 87% (drug 58%) · 85% consumer | no trial data cached |
| Product administration error | 58 | 18.5 14.4–23.9ROR 18.8 · χ² 943 / p 3e-207 | 18.4 EB05 14.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · ♀ 81% (drug 58%) | no trial data cached |
| Mood swings | 55 | 11.0 8.4–14.3ROR 11.2 · χ² 489 / p 1e-108 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 81% (drug 58%) · 82% consumer | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 52 | 2.4 1.9–3.2ROR 2.5 · χ² 43 / p 3e-11 | 2.4 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.3 · 98% clinician | 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.
- Needle issue — n=197, PRR 44.1
- Syringe issue — n=90, PRR 32.8
- Affect lability — n=39, PRR 25.8
- Vaginal haemorrhage — n=94, PRR 14.1
- Metastases to bone — n=31, PRR 12.1
- Mood swings — n=55, PRR 11.0
- Increased appetite — n=25, PRR 8.5
- Erectile dysfunction — n=31, PRR 7.7
- Rhabdomyolysis — n=43, PRR 6.6
- Ascites — n=29, PRR 6.3
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 Triptorelin?
In FDA FAERS, the most frequently co-reported reaction terms for Triptorelin are needle issue, injection site pain, weight increased, vaginal haemorrhage, syringe issue, hot flush. 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 Triptorelin have an FDA boxed warning?
No. The FDA label retrieved for Triptorelin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Triptorelin 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 f41380e7-b830-432d-a5f5-a872932f107e, effective 20250914; matched on
openfda.generic_name.exact:"TRIPTORELIN") - 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, 102 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.