Drug · FAERS side-effect profile with label screen

Histrelin side effects: what 875 FDA adverse event reports show

Histrelin Acetate · 20 reaction terms · 435 drug–reaction co-reports · data 2026-09-14

Drug class

Gonadotropin releasing hormone (gnrh) agonist

FDA label, Indications wording of the closest related product

Label matched

Histrelin Acetate (Supprelin La)

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

Who reports

875 reports · 21% serious · 28 with death outcome · 77% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment.

FDA label, Indications and Usage

What it is

SUPPRELIN LA is a sterile, non-biodegradable, diffusion-controlled, hydrogel polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) possessing a greater potency than the natural sequence hormone.

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 15 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Reporting / coding artifact 7Not in label — unassessed 3

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.
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
Device breakage	117	71.6 60.5–84.8ROR 82.5 · χ² 8,063 / p <1e-300	70.6 EB05 60.5 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 38.6	no trial data cached
Incorrect product administration duration	60	71.1 55.6–90.8ROR 76.2 · χ² 4,066 / p <1e-300	69.4 EB05 55.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Incorrect drug administration duration	65	54.7 43.3–69.2ROR 59.0 · χ² 3,371 / p <1e-300	53.8 EB05 43.7 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious PRR 58.4	no trial data cached
Dermatitis contact	12	25.3 14.4–44.5ROR 25.7 · χ² 257 / p 5e-58	24.3 EB05 14.6 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Mood swings	28	21.1 14.6–30.3ROR 21.7 · χ² 515 / p 2e-114	20.8 EB05 15.0 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.2 · 71% consumer	no trial data cached
Menstruation delayed	8	18.5 9.3–36.8ROR 18.6 · χ² 115 / p 3e-27	16.5 EB05 7.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Complication of device removal	13	18.4 10.7–31.5ROR 18.6 · χ² 197 / p 6e-45	17.5 EB05 10.3 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.4	no trial data cached
Scar	9	12.6 6.6–24.1ROR 12.7 · χ² 85 / p 2e-20	10.3 EB05 5.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	no trial data cached
Affect lability	5	12.4 5.2–29.7ROR 12.5 · χ² 42 / p 6e-11	8.2 EB05 3.1 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Device dislocation	22	12.2 8.0–18.4ROR 12.4 · χ² 214 / p 7e-49	11.4 EB05 7.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.9	no trial data cached
Rash generalised	12	11.0 6.2–19.2ROR 11.1 · χ² 99 / p 1e-23	9.2 EB05 5.1 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.5	no trial data cached
Rash pruritic	23	10.2 6.8–15.3ROR 10.5 · χ² 183 / p 7e-42	9.3 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Device expulsion	27	9.9 6.8–14.4ROR 10.2 · χ² 208 / p 2e-47	9.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 54.0	no trial data cached
Device defective	5	7.4 3.1–17.8ROR 7.4 · χ² 22 / p 2e-6	4.8 EB05 2.2 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug effect decreased	12	5.3 3.0–9.2ROR 5.3 · χ² 37 / p 5e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4	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
Device breakage	117	71.6 60.5–84.8ROR 82.5 · χ² 8,063 / p <1e-300	70.6 EB05 60.5 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 38.6	no trial data cached
Incorrect drug administration duration	65	54.7 43.3–69.2ROR 59.0 · χ² 3,371 / p <1e-300	53.8 EB05 43.7 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious PRR 58.4	no trial data cached
Incorrect product administration duration	60	71.1 55.6–90.8ROR 76.2 · χ² 4,066 / p <1e-300	69.4 EB05 55.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Mood swings	28	21.1 14.6–30.3ROR 21.7 · χ² 515 / p 2e-114	20.8 EB05 15.0 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.2 · 71% consumer	no trial data cached
Device expulsion	27	9.9 6.8–14.4ROR 10.2 · χ² 208 / p 2e-47	9.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 54.0	no trial data cached
Rash pruritic	23	10.2 6.8–15.3ROR 10.5 · χ² 183 / p 7e-42	9.3 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Device dislocation	22	12.2 8.0–18.4ROR 12.4 · χ² 214 / p 7e-49	11.4 EB05 7.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.9	no trial data cached
Complication of device removal	13	18.4 10.7–31.5ROR 18.6 · χ² 197 / p 6e-45	17.5 EB05 10.3 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.4	no trial data cached
Drug effect decreased	12	5.3 3.0–9.2ROR 5.3 · χ² 37 / p 5e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4	no trial data cached
Rash generalised	12	11.0 6.2–19.2ROR 11.1 · χ² 99 / p 1e-23	9.2 EB05 5.1 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.5	no trial data cached
Dermatitis contact	12	25.3 14.4–44.5ROR 25.7 · χ² 257 / p 5e-58	24.3 EB05 14.6 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Scar	9	12.6 6.6–24.1ROR 12.7 · χ² 85 / p 2e-20	10.3 EB05 5.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	no trial data cached
Menstruation delayed	8	18.5 9.3–36.8ROR 18.6 · χ² 115 / p 3e-27	16.5 EB05 7.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Device defective	5	7.4 3.1–17.8ROR 7.4 · χ² 22 / p 2e-6	4.8 EB05 2.2 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Affect lability	5	12.4 5.2–29.7ROR 12.5 · χ² 42 / p 6e-11	8.2 EB05 3.1 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	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.

Rash pruritic — n=23, PRR 10.2

✓ 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 Histrelin?

In FDA FAERS, the most frequently co-reported reaction terms for Histrelin are mood swings, rash pruritic, complication of device removal, rash generalised, dermatitis contact, scar. 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 Histrelin have an FDA boxed warning?

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

Do FAERS signals prove that Histrelin 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 d8fb000e-3cc9-4803-b71d-2cc597661977, effective 20250925; matched on openfda.generic_name.exact:"HISTRELIN 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, 20 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.