Drug · FAERS side-effect profile with label screen

Bromocriptine side effects: what 646 FDA adverse event reports show

Bromocriptine Mesylate · 28 reaction terms · 257 drug–reaction co-reports · data 2026-09-14

Drug class

Ergot derivative

FDA label, Indications wording of the closest related product

Label matched

Bromocriptine Mesylate (Bromocriptine Mesylate)

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

Who reports

646 reports · 79% serious · 30 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults (1.1) Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older (1.2). Acromegaly in adults (1.3).

FDA label, Indications and Usage

What it is

Bromocriptine mesylate is an ergot derivative with potent dopamine receptor agonist activity. Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′hydroxy-2′-(1-methylethyl)-5′-(2-methylpropyl)-, (5′α)-monomethanesulfonate (salt).

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 20 strongest signals

Labeled adverse reaction 4Labeled (related wording) 2Reporting / coding artifact 3Lab value / disease marker 4Not in label — unassessed 7

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.
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. 8 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
Neuroleptic malignant syndrome	24	65.6 44.3–97.2ROR 68.1 · χ² 1,462 / p <1e-300	62.4 EB05 44.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.7 · ♀ 30% (drug 55%)	no trial data cached
Muscle rigidity	16	43.5 26.8–70.6ROR 44.6 · χ² 622 / p 1e-137	41.5 EB05 27.1 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.4	no trial data cached
Drug exposure during pregnancy	25	23.5 16.0–34.6ROR 24.4 · χ² 518 / p 7e-115	23.2 EB05 16.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 18.2 · ♀ 83% (drug 55%)	no trial data cached
Mitral valve incompetence	7	20.1 9.6–42.0ROR 20.3 · χ² 109 / p 1e-25	17.7 EB05 7.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.7	no trial data cached
Blood creatine phosphokinase increased	18	20.0 12.7–31.5ROR 20.5 · χ² 306 / p 7e-69	19.5 EB05 12.9 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 16.2	no trial data cached
Caesarean section	7	19.3 9.2–40.4ROR 19.5 · χ² 104 / p 1e-24	16.9 EB05 7.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Serotonin syndrome	11	18.7 10.4–33.6ROR 19.0 · χ² 167 / p 2e-38	17.6 EB05 9.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Status epilepticus	6	17.2 7.8–38.2ROR 17.4 · χ² 76 / p 1e-18	13.8 EB05 5.1 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.5	no trial data cached
Hallucination, visual	11	17.0 9.5–30.6ROR 17.3 · χ² 150 / p 7e-35	15.8 EB05 8.4 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.1	no trial data cached
Delusion	8	16.8 8.4–33.4ROR 17.0 · χ² 103 / p 1e-24	14.6 EB05 6.5 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.7	no trial data cached
Blood lactate dehydrogenase increased	8	16.3 8.2–32.4ROR 16.5 · χ² 100 / p 7e-24	14.1 EB05 6.2 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 12.6	no trial data cached
Premature baby	12	12.9 7.4–22.6ROR 13.1 · χ² 120 / p 3e-28	11.4 EB05 6.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Psychotic disorder	11	12.1 6.7–21.7ROR 12.3 · χ² 101 / p 4e-24	10.3 EB05 5.4 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached
Psychomotor hyperactivity	6	11.7 5.3–25.9ROR 11.8 · χ² 48 / p 2e-12	8.2 EB05 3.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Abnormal behaviour	14	11.4 6.8–19.1ROR 11.6 · χ² 123 / p 8e-29	10.0 EB05 5.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Blood glucose decreased	14	9.4 5.6–15.8ROR 9.6 · χ² 97 / p 3e-23	7.9 EB05 4.8 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 9.0	no trial data cached
Drug resistance	7	8.8 4.2–18.5ROR 8.9 · χ² 41 / p 7e-11	6.3 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.2	no trial data cached
Glycosylated haemoglobin increased	5	6.4 2.7–15.4ROR 6.5 · χ² 18 / p 1e-5	4.3 EB05 2.0 · IC025 +0.5 3/3 methods agree	Lab value / disease marker	serious PRR 2.1	no trial data cached
Foetal exposure during pregnancy	11	4.4 2.4–7.9ROR 4.5 · χ² 26 / p 2e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Bladder cancer	6	3.3 1.5–7.2ROR 3.3 · χ² 7 / p 0.003	2.8 EB05 1.4 · IC025 +0.1	Not in label — unassessed	serious PRR 2.4	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
Drug exposure during pregnancy	25	23.5 16.0–34.6ROR 24.4 · χ² 518 / p 7e-115	23.2 EB05 16.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 18.2 · ♀ 83% (drug 55%)	no trial data cached
Neuroleptic malignant syndrome	24	65.6 44.3–97.2ROR 68.1 · χ² 1,462 / p <1e-300	62.4 EB05 44.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.7 · ♀ 30% (drug 55%)	no trial data cached
Blood creatine phosphokinase increased	18	20.0 12.7–31.5ROR 20.5 · χ² 306 / p 7e-69	19.5 EB05 12.9 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 16.2	no trial data cached
Muscle rigidity	16	43.5 26.8–70.6ROR 44.6 · χ² 622 / p 1e-137	41.5 EB05 27.1 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.4	no trial data cached
Blood glucose decreased	14	9.4 5.6–15.8ROR 9.6 · χ² 97 / p 3e-23	7.9 EB05 4.8 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 9.0	no trial data cached
Abnormal behaviour	14	11.4 6.8–19.1ROR 11.6 · χ² 123 / p 8e-29	10.0 EB05 5.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Premature baby	12	12.9 7.4–22.6ROR 13.1 · χ² 120 / p 3e-28	11.4 EB05 6.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Foetal exposure during pregnancy	11	4.4 2.4–7.9ROR 4.5 · χ² 26 / p 2e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Psychotic disorder	11	12.1 6.7–21.7ROR 12.3 · χ² 101 / p 4e-24	10.3 EB05 5.4 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached
Hallucination, visual	11	17.0 9.5–30.6ROR 17.3 · χ² 150 / p 7e-35	15.8 EB05 8.4 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.1	no trial data cached
Serotonin syndrome	11	18.7 10.4–33.6ROR 19.0 · χ² 167 / p 2e-38	17.6 EB05 9.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Blood lactate dehydrogenase increased	8	16.3 8.2–32.4ROR 16.5 · χ² 100 / p 7e-24	14.1 EB05 6.2 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 12.6	no trial data cached
Delusion	8	16.8 8.4–33.4ROR 17.0 · χ² 103 / p 1e-24	14.6 EB05 6.5 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.7	no trial data cached
Drug resistance	7	8.8 4.2–18.5ROR 8.9 · χ² 41 / p 7e-11	6.3 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.2	no trial data cached
Caesarean section	7	19.3 9.2–40.4ROR 19.5 · χ² 104 / p 1e-24	16.9 EB05 7.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	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 Bromocriptine?

In FDA FAERS, the most frequently co-reported reaction terms for Bromocriptine are neuroleptic malignant syndrome, blood creatine phosphokinase increased, muscle rigidity, blood glucose decreased, abnormal behaviour, premature baby. 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 Bromocriptine have an FDA boxed warning?

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

Do FAERS signals prove that Bromocriptine 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 17f3a343-1782-4799-95ba-31dfe93be2cf, effective 20260727; matched on openfda.generic_name.exact:"BROMOCRIPTINE MESYLATE")
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, 28 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.