Bremelanotide side effects: what 1,004 FDA adverse event reports show

Bremelanotide · Vyleesi · 13 reaction terms · 717 drug–reaction co-reports · data 2026-09-14

Drug class

Melanocortin receptor agonist

FDA label, Indications wording

Brand names

Vyleesi

openFDA label

Who reports

1,004 reports · 3% serious · 1 with death outcome · 95% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance.

FDA label, Indications and Usage

What it is

VYLEESI (bremelanotide injection) contains bremelanotide, a melanocortin receptor agonist for subcutaneous administration via an autoinjector. Bremelanotide acetate is a synthetic, cyclic hept.

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 10 strongest signals

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

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. 3 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
Restless legs syndrome	18	20.7 13.1–32.7ROR 21.0 · χ² 317 / p 3e-71	20.2 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 34.9	no trial data cached
Illness	72	15.0 12.0–18.7ROR 16.1 · χ² 929 / p 3e-204	14.9 EB05 12.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	89% consumer	no trial data cached
Flushing	72	14.7 11.8–18.4ROR 15.8 · χ² 912 / p 1e-200	14.6 EB05 12.0 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 40.6 · 79% consumer	no trial data cached
Libido decreased (lower sex drive)	8	13.5 6.8–26.9ROR 13.6 · χ² 80 / p 1e-19	10.9 EB05 4.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Adverse reaction	8	12.6 6.3–25.1ROR 12.7 · χ² 74 / p 3e-18	10.0 EB05 4.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Adverse drug reaction	53	12.4 9.5–16.1ROR 13.0 · χ² 545 / p 7e-121	12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 12.6 · 100% consumer	no trial data cached
Nausea	432	11.4 10.7–12.3ROR 19.3 · χ² 4,265 / p <1e-300	11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7 · 87% consumer	no trial data cached
Hot flush (hot flashes)	23	6.4 4.3–9.5ROR 6.5 · χ² 99 / p 1e-23	5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	96% consumer	no trial data cached
Injection site pruritus	15	4.7 2.8–7.8ROR 4.8 · χ² 40 / p 1e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Injection site rash	6	4.1 1.9–9.2ROR 4.1 · χ² 11 / p 4e-4	3.3 EB05 1.7 · IC025 +0.3	Labeled (related wording) related wording	–	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
Nausea	432	11.4 10.7–12.3ROR 19.3 · χ² 4,265 / p <1e-300	11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7 · 87% consumer	no trial data cached
Flushing	72	14.7 11.8–18.4ROR 15.8 · χ² 912 / p 1e-200	14.6 EB05 12.0 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 40.6 · 79% consumer	no trial data cached
Illness	72	15.0 12.0–18.7ROR 16.1 · χ² 929 / p 3e-204	14.9 EB05 12.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	89% consumer	no trial data cached
Adverse drug reaction	53	12.4 9.5–16.1ROR 13.0 · χ² 545 / p 7e-121	12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 12.6 · 100% consumer	no trial data cached
Hot flush (hot flashes)	23	6.4 4.3–9.5ROR 6.5 · χ² 99 / p 1e-23	5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	96% consumer	no trial data cached
Restless legs syndrome	18	20.7 13.1–32.7ROR 21.0 · χ² 317 / p 3e-71	20.2 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 34.9	no trial data cached
Injection site pruritus	15	4.7 2.8–7.8ROR 4.8 · χ² 40 / p 1e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Adverse reaction	8	12.6 6.3–25.1ROR 12.7 · χ² 74 / p 3e-18	10.0 EB05 4.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Libido decreased (lower sex drive)	8	13.5 6.8–26.9ROR 13.6 · χ² 80 / p 1e-19	10.9 EB05 4.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Injection site rash	6	4.1 1.9–9.2ROR 4.1 · χ² 11 / p 4e-4	3.3 EB05 1.7 · IC025 +0.3	Labeled (related wording) related wording	–	no trial data cached
Product complaint	4	3.3 1.3–8.9ROR 3.4 · χ² 4 / p 0.017	2.6 EB05 1.2 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Injection site urticaria	3	2.6 0.8–8.0ROR 2.6 · χ² 2 / p 0.107	2.1 EB05 0.9 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	–	no trial data cached
Vaginal discharge	3	6.2 2.0–19.3ROR 6.3 · χ² 8 / p 0.002	3.6 EB05 1.4 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=1	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Bremelanotide?

In FDA FAERS, the most frequently co-reported reaction terms for Bremelanotide are nausea, flushing, hot flush, restless legs syndrome, injection site pruritus, libido decreased. 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 Bremelanotide have an FDA boxed warning?

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

Do FAERS signals prove that Bremelanotide 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 f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf, effective 20251113; matched on openfda.generic_name.exact:"BREMELANOTIDE")
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, 13 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.