Drug · FAERS side-effect profile with label screen
Cabergoline side effects: what 4,835 FDA adverse event reports show
Drug class
Ergot Derivative
FDA label (Established Pharmacologic Class)
Who reports
4,835 reports · 82% serious · 253 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cabergoline tablets is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions .
FDA label, Indications and Usage
What it is
Cabergoline is an ergot derivative and dopamine receptor agonist.
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 (related wording) 2Reporting / coding artifact 3Lab value / disease marker 5Not in label — unassessed 30
What the badges mean
- 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. 347 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 |
|---|---|---|---|---|---|---|
| Mitral valve incompetence | 101 | 39.0 32.1–47.4ROR 39.8 · χ² 3,672 / p <1e-300 | 38.4 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 98% clinician | no trial data cached |
| Obesity | 74 | 20.2 16.1–25.3ROR 20.5 · χ² 1,325 / p 2e-290 | 20.0 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 83% (drug 59%) | no trial data cached |
| Knee arthroplasty | 85 | 17.7 14.4–21.9ROR 18.0 · χ² 1,322 / p 1e-289 | 17.6 EB05 14.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Body temperature decreased | 36 | 15.8 11.4–21.8ROR 15.9 · χ² 482 / p 5e-107 | 15.5 EB05 11.6 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.3 | no trial data cached |
| Adrenal insufficiency | 40 | 14.5 10.7–19.8ROR 14.6 · χ² 489 / p 1e-108 | 14.3 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Schizophrenia | 37 | 13.2 9.6–18.2ROR 13.3 · χ² 405 / p 2e-90 | 12.9 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 0% (drug 59%) | no trial data cached |
| Blood pressure systolic increased | 56 | 12.4 9.6–16.1ROR 12.6 · χ² 576 / p 2e-127 | 12.2 EB05 9.6 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 · ♀ 81% (drug 59%) | no trial data cached |
| Delusion | 44 | 12.3 9.2–16.6ROR 12.4 · χ² 447 / p 2e-99 | 12.0 EB05 9.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 100% clinician | no trial data cached |
| Cardiomegaly | 34 | 11.9 8.5–16.7ROR 12.0 · χ² 328 / p 1e-73 | 11.4 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 33% (drug 59%) | no trial data cached |
| Lower respiratory tract infection | 119 | 11.4 9.6–13.6ROR 11.7 · χ² 1,119 / p 1e-245 | 11.3 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Sleep apnoea syndrome | 50 | 11.4 8.6–15.0ROR 11.5 · χ² 461 / p 1e-102 | 11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Drug resistance | 62 | 10.5 8.2–13.4ROR 10.6 · χ² 522 / p 8e-116 | 10.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | no trial data cached |
| Arthropathy | 134 | 10.4 8.8–12.3ROR 10.7 · χ² 1,134 / p 7e-249 | 10.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Neoplasm | 27 | 10.2 7.0–14.8ROR 10.2 · χ² 214 / p 9e-49 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Cholelithiasis | 76 | 10.1 8.0–12.6ROR 10.2 · χ² 611 / p 4e-135 | 9.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Gastrointestinal pain | 25 | 9.9 6.7–14.7ROR 10.0 · χ² 191 / p 9e-44 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · ♀ 0% (drug 59%) | no trial data cached |
| Neoplasm progression | 78 | 9.6 7.7–12.0ROR 9.8 · χ² 596 / p 7e-132 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Brain neoplasm | 20 | 9.4 6.1–14.6ROR 9.5 · χ² 143 / p 4e-33 | 8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Nocturia (night-time urination) | 23 | 8.2 5.5–12.4ROR 8.3 · χ² 139 / p 2e-32 | 7.4 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 100% (drug 59%) | no trial data cached |
| Blood iron decreased | 22 | 8.1 5.3–12.3ROR 8.1 · χ² 130 / p 2e-30 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 · ♀ 100% (drug 59%) | no trial data cached |
| Nerve injury | 20 | 7.8 5.0–12.1ROR 7.8 · χ² 111 / p 2e-26 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Neuroleptic malignant syndrome | 21 | 7.7 5.0–11.8ROR 7.7 · χ² 115 / p 4e-27 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hepatic steatosis | 32 | 7.5 5.3–10.5ROR 7.5 · χ² 173 / p 1e-39 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 87% (drug 59%) | no trial data cached |
| Thyroid disorder | 26 | 7.3 5.0–10.7ROR 7.4 · χ² 136 / p 1e-31 | 6.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 85% (drug 59%) | no trial data cached |
| Irritable bowel syndrome | 35 | 7.1 5.1–9.9ROR 7.2 · χ² 178 / p 8e-41 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 0% (drug 59%) | no trial data cached |
| Pulmonary hypertension | 34 | 7.1 5.0–9.9ROR 7.1 · χ² 171 / p 3e-39 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 90% clinician | no trial data cached |
| Muscle rigidity | 19 | 6.9 4.4–10.8ROR 6.9 · χ² 90 / p 1e-21 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Drug abuse | 132 | 6.8 5.8–8.1ROR 7.0 · χ² 655 / p 9e-145 | 6.7 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Hallucination, visual | 33 | 6.8 4.9–9.6ROR 6.9 · χ² 158 / p 1e-36 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 56 | 6.7 5.2–8.7ROR 6.8 · χ² 265 / p 6e-60 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Hallucination, auditory | 24 | 6.5 4.4–9.8ROR 6.6 · χ² 107 / p 2e-25 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Needle issue | 43 | 6.5 4.8–8.8ROR 6.6 · χ² 196 / p 1e-44 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Blood urea increased | 24 | 6.2 4.1–9.2ROR 6.2 · χ² 99 / p 1e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 · ♀ 96% (drug 59%) | no trial data cached |
| Intentional product misuse | 121 | 6.0 5.1–7.2ROR 6.2 · χ² 506 / p 3e-112 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 | no trial data cached |
| Body height decreased | 15 | 6.0 3.6–10.0ROR 6.0 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 14 | 6.0 3.5–10.1ROR 6.0 · χ² 53 / p 2e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Restless legs syndrome | 25 | 6.0 4.0–8.8ROR 6.0 · χ² 98 / p 2e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Spinal pain | 16 | 5.9 3.6–9.7ROR 5.9 · χ² 61 / p 3e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Blood potassium increased | 22 | 5.9 3.9–8.9ROR 5.9 · χ² 84 / p 2e-20 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 90% (drug 59%) | no trial data cached |
| Pulmonary mass | 20 | 5.8 3.8–9.0ROR 5.9 · χ² 75 / p 2e-18 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 · ♀ 100% (drug 59%) | 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 |
|---|---|---|---|---|---|---|
| Headache | 339 | 2.3 2.1–2.6ROR 2.4 · χ² 269 / p 1e-60 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Malaise (feeling unwell) | 214 | 2.1 1.9–2.4ROR 2.2 · χ² 127 / p 1e-29 | 2.1 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Condition aggravated | 175 | 2.5 2.2–2.9ROR 2.6 · χ² 160 / p 5e-37 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Product dose omission issue | 174 | 2.6 2.3–3.1ROR 2.7 · χ² 179 / p 3e-41 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Abdominal discomfort | 168 | 4.4 3.8–5.1ROR 4.5 · χ² 435 / p 8e-97 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Anxiety | 161 | 2.4 2.1–2.8ROR 2.5 · χ² 138 / p 3e-32 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 · ♀ 83% (drug 59%) | no trial data cached |
| Fall | 153 | 2.0 1.7–2.3ROR 2.0 · χ² 76 / p 1e-18 | 2.0 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Drug interaction | 144 | 3.9 3.4–4.6ROR 4.0 · χ² 315 / p 1e-70 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Arthropathy | 134 | 10.4 8.8–12.3ROR 10.7 · χ² 1,134 / p 7e-249 | 10.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Drug abuse | 132 | 6.8 5.8–8.1ROR 7.0 · χ² 655 / p 9e-145 | 6.7 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Blood pressure increased | 124 | 3.5 2.9–4.2ROR 3.6 · χ² 221 / p 2e-50 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Intentional product misuse | 121 | 6.0 5.1–7.2ROR 6.2 · χ² 506 / p 3e-112 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 | no trial data cached |
| Lower respiratory tract infection | 119 | 11.4 9.6–13.6ROR 11.7 · χ² 1,119 / p 1e-245 | 11.3 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Overdose | 115 | 2.3 1.9–2.8ROR 2.3 · χ² 84 / p 2e-20 | 2.3 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Gait disturbance | 113 | 2.6 2.1–3.1ROR 2.6 · χ² 106 / p 4e-25 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | 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.
- Mitral valve incompetence — n=101, PRR 39.0
- Obesity — n=74, PRR 20.2
- Knee arthroplasty — n=85, PRR 17.7
- Adrenal insufficiency — n=40, PRR 14.5
- Schizophrenia — n=37, PRR 13.2
- Delusion — n=44, PRR 12.3
- Cardiomegaly — n=34, PRR 11.9
- Lower respiratory tract infection — n=119, PRR 11.4
- Sleep apnoea syndrome — n=50, PRR 11.4
- Arthropathy — n=134, PRR 10.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Cabergoline ↔ Pleural effusion.
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 Cabergoline?
In FDA FAERS, the most frequently co-reported reaction terms for Cabergoline are headache, malaise, abdominal discomfort, anxiety, fall, arthropathy. 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 Cabergoline have an FDA boxed warning?
No. The FDA label retrieved for Cabergoline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cabergoline 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 8562f94f-a59a-4893-aefc-ea6547b01e92, effective 20260622; matched on
openfda.generic_name.exact:"CABERGOLINE") - 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, 387 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.