Triptorelin Pamoate side effects: what 2,579 FDA adverse event reports show
Drug class
Gonadotropin releasing hormone (gnrh) agonist
Brand names
Triptodur
Who reports
2,579 reports · 72% serious · 530 with death outcome · 22% female
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 )
What it is
TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH).
Boxed warning
None in the current label
Causality screen of the 32 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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 39 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 | 86 | 50.8 41.2–62.5ROR 52.5 · χ² 4,122 / p <1e-300 | 49.9 EB05 41.7 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 50.9 · ♀ 0% (drug 22%) | no trial data cached |
| Metastases to bone | 42 | 20.9 15.5–28.2ROR 21.2 · χ² 775 / p 6e-171 | 20.7 EB05 15.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Syringe issue | 36 | 16.7 12.1–23.1ROR 16.9 · χ² 516 / p 2e-114 | 16.5 EB05 12.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Hot flush (hot flashes) | 126 | 13.6 11.5–16.1ROR 14.3 · χ² 1,462 / p <1e-300 | 13.5 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 | no trial data cached |
| Blood pressure systolic increased | 32 | 13.3 9.4–18.8ROR 13.4 · χ² 351 / p 1e-78 | 12.9 EB05 9.3 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.6 · ♀ 0% (drug 22%) | no trial data cached |
| Muscle atrophy | 14 | 9.1 5.4–15.3ROR 9.1 · χ² 92 / p 4e-22 | 7.6 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Needle issue | 30 | 8.5 6.0–12.2ROR 8.6 · χ² 192 / p 6e-44 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Osteopenia | 15 | 8.0 4.8–13.2ROR 8.0 · χ² 85 / p 2e-20 | 6.7 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Increased appetite | 16 | 6.9 4.2–11.3ROR 7.0 · χ² 75 / p 2e-18 | 5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Blood pressure abnormal | 16 | 6.6 4.0–10.7ROR 6.6 · χ² 70 / p 3e-17 | 5.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 | no trial data cached |
| Malignant neoplasm progression | 82 | 6.5 5.3–8.1ROR 6.7 · χ² 381 / p 3e-85 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 0% (drug 22%) | no trial data cached |
| Incorrect dose administered by device | 20 | 6.4 4.1–9.9ROR 6.4 · χ² 86 / p 9e-21 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% clinician | no trial data cached |
| Disease progression | 78 | 5.4 4.3–6.7ROR 5.5 · χ² 275 / p 5e-62 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 54% (drug 22%) | no trial data cached |
| Mood altered | 17 | 5.1 3.2–8.2ROR 5.1 · χ² 52 / p 3e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Inappropriate schedule of product administration | 108 | 5.0 4.1–6.0ROR 5.1 · χ² 341 / p 2e-76 | 4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 | no trial data cached |
| Injury associated with device | 12 | 4.9 2.8–8.5ROR 4.9 · χ² 33 / p 5e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Mood swings | 19 | 4.8 3.1–7.6ROR 4.9 · χ² 54 / p 9e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Hip fracture | 19 | 4.8 3.1–7.5ROR 4.8 · χ² 54 / p 1e-13 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Product administration error | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 26 / p 1e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Device malfunction | 33 | 4.0 2.8–5.6ROR 4.0 · χ² 71 / p 2e-17 | 3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Death | 405 | 3.8 3.5–4.2ROR 4.3 · χ² 877 / p 4e-193 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.0 · ♀ 1% (drug 22%) · 71% consumer | no trial data cached |
| Bone pain | 27 | 3.7 2.6–5.4ROR 3.8 · χ² 52 / p 3e-13 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Emotional disorder | 14 | 3.7 2.2–6.2ROR 3.7 · χ² 25 / p 4e-7 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 0.8 | no trial data cached |
| Device issue | 36 | 3.4 2.4–4.6ROR 3.4 · χ² 57 / p 2e-14 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product dose omission | 24 | 2.9 2.0–4.4ROR 3.0 · χ² 29 / p 4e-8 | 2.8 EB05 2.0 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Dementia | 10 | 2.9 1.6–5.4ROR 2.9 · χ² 11 / p 5e-4 | 2.7 EB05 1.6 · IC025 +0.3 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Accidental exposure to product | 34 | 2.8 2.0–3.9ROR 2.8 · χ² 37 / p 7e-10 | 2.7 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Abortion spontaneous | 13 | 2.6 1.5–4.5ROR 2.6 · χ² 12 / p 3e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Prostate cancer | 26 | 2.6 1.8–3.8ROR 2.6 · χ² 24 / p 4e-7 | 2.5 EB05 1.8 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 · ♀ 0% (drug 22%) | no trial data cached |
| Gynaecomastia (male breast enlargement) | 10 | 2.6 1.4–4.8ROR 2.6 · χ² 8 / p 0.002 | 2.4 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Neoplasm progression | 10 | 2.3 1.2–4.3ROR 2.3 · χ² 6 / p 0.006 | 2.2 EB05 1.3 · IC025 +0.0 | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Vaginal haemorrhage | 12 | 2.3 1.3–4.0ROR 2.3 · χ² 7 / p 0.003 | 2.2 EB05 1.4 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.0 | 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 |
|---|---|---|---|---|---|---|
| Death | 405 | 3.8 3.5–4.2ROR 4.3 · χ² 877 / p 4e-193 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.0 · ♀ 1% (drug 22%) · 71% consumer | no trial data cached |
| Hot flush (hot flashes) | 126 | 13.6 11.5–16.1ROR 14.3 · χ² 1,462 / p <1e-300 | 13.5 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 | no trial data cached |
| Inappropriate schedule of product administration | 108 | 5.0 4.1–6.0ROR 5.1 · χ² 341 / p 2e-76 | 4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 | no trial data cached |
| Prostatic specific antigen increased | 86 | 50.8 41.2–62.5ROR 52.5 · χ² 4,122 / p <1e-300 | 49.9 EB05 41.7 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 50.9 · ♀ 0% (drug 22%) | no trial data cached |
| Malignant neoplasm progression | 82 | 6.5 5.3–8.1ROR 6.7 · χ² 381 / p 3e-85 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 0% (drug 22%) | no trial data cached |
| Disease progression | 78 | 5.4 4.3–6.7ROR 5.5 · χ² 275 / p 5e-62 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 54% (drug 22%) | no trial data cached |
| Incorrect dose administered | 47 | 1.7 1.3–2.3ROR 1.7 · χ² 13 / p 2e-4 | 1.7 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 0.7 | no trial data cached |
| Wrong technique in product usage process | 47 | 1.9 1.4–2.5ROR 1.9 · χ² 19 / p 6e-6 | 1.9 EB05 1.5 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Metastases to bone | 42 | 20.9 15.5–28.2ROR 21.2 · χ² 775 / p 6e-171 | 20.7 EB05 15.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Device issue | 36 | 3.4 2.4–4.6ROR 3.4 · χ² 57 / p 2e-14 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Syringe issue | 36 | 16.7 12.1–23.1ROR 16.9 · χ² 516 / p 2e-114 | 16.5 EB05 12.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Accidental exposure to product | 34 | 2.8 2.0–3.9ROR 2.8 · χ² 37 / p 7e-10 | 2.7 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Device malfunction | 33 | 4.0 2.8–5.6ROR 4.0 · χ² 71 / p 2e-17 | 3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Blood pressure systolic increased | 32 | 13.3 9.4–18.8ROR 13.4 · χ² 351 / p 1e-78 | 12.9 EB05 9.3 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.6 · ♀ 0% (drug 22%) | no trial data cached |
| Needle issue | 30 | 8.5 6.0–12.2ROR 8.6 · χ² 192 / p 6e-44 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=6 | 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=42, PRR 20.9
- Syringe issue — n=36, PRR 16.7
- Needle issue — n=30, PRR 8.5
- Bone pain — n=27, PRR 3.7
- Prostate cancer — n=26, PRR 2.6
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 hot flush, prostatic specific antigen increased, metastases to bone, syringe issue, blood pressure systolic increased, needle issue. 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, 71 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.