What the label lists and what reports show
Bromocriptine side effects
Bromocriptine's FDA label: “Most common adverse reactions: (6.1) Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas: (incidence >5%) are nausea, headache, dizziness, fatigue, lightheadedness, and vomiting.” FAERS holds 646 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (46 reports).
- Generic listed
Check it at the source: the bromocriptine FDA label on DailyMed (effective July 27, 2026, ANI Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CYCLOSET?CYCLOSET may cause serious side effects, including: Low blood pressure (hypotension) including low blood pressure when you suddenly change positions (orthostatic hypotension). This can happen more often when first starting CYCLOSET or if your dose is increased. Symptoms of low blood pressure when you suddenly change positions can include dizziness, nausea, sweating, fainting or light-headedness. Stand up slowly when moving from a sitting or lying position. You should avoid activities that could cause injury if you feel light-headed or faint. Feeling tired and sleepy (somnolence). Tiredness and sleepiness can happen with CYCLOSET, especially when first starting CYCLOSET. Tiredness and sleepiness are common but can also be serious. If you feel tired and sleepy while taking CYCLOSET, you should not drive or operate heavy machinery. Uncontrollable (compulsive) behaviors. […]
Source: FDA drug label (CYCLOSET), Avvisto Therapeutics LLC, effective January 12, 2026 (SPL set e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions: (6.1) Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas: (incidence >5%) are nausea, headache, dizziness, fatigue, lightheadedness, and vomiting.
Table 1: Adverse Reactions Occurring in ≥5% in CYCLOSET-Treated Patients and More Frequent than in Placebo in CYCLOSET Clinical Trials All randomized subjects receiving at least one dose of study drug
This table is printed in the CYCLOSET label published by Avvisto Therapeutics LLC of January 12, 2026; the label quoted above does not print one.
| Monotherapy N = 159 | CYCLOSET 1.6 mg – 4.8 mg N (%) N = 80 | Placebo N (%) N = 79 |
|---|---|---|
| Nausea | 26 (32.5) | 6 (7.6) |
| Rhinitis | 11 (13.8) | 3 (3.8) |
| Headache | 10 (12.5) | 7 (8.9) |
| Asthenia | 10 (12.5) | 5 (6.3) |
| Dizziness | 10 (12.5) | 6 (7.6) |
| Constipation | 9 (11.3) | 3 (3.8) |
| Sinusitis | 8 (10.0) | 2 (2.5) |
| Diarrhea | 7 (8.8) | 4 (5.1) |
| Amblyopia | 6 (7.5) | 1 (1.3) |
| Dyspepsia | 6 (7.5) | 2 (2.5) |
| Vomiting | 5 (6.3) | 1 (1.3) |
| Infection | 5 (6.3) | 4 (5.1) |
| Anorexia | 4 (5.0) | 1 (1.3) |
| Nausea | 62 (25.4) | 12 (4.8) |
| Asthenia | 46 (18.9) | 20 (8.0) |
| Headache | 41 (16.8) | 40 (16.0) |
| Flu syndrome | 23 (9.4) | 19 (7.6) |
| Constipation | 24 (9.8) | 11 (4.4) |
| Cold | 20 (8.2) | 20 (8.0) |
| Dizziness | 29 (11.9) | 14 (5.6) |
| Rhinitis | 26 (10.7) | 12 (4.8) |
| Sinusitis | 18 (7.4) | 16 (6.4) |
| Somnolence | 16 (6.6) | 5 (2.0) |
| Vomiting | 13 (5.3) | 8 (3.2) |
| Amblyopia | 13 (5.3) | 6 (2.4) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions (5.1)] Pleural, Pulmonary, and Retroperitoneal Fibrosis [see Warnings and Precautions (5.2)] Hypotension/Orthostatic Hypotension [see Warnings and Precautions (5.3)] Risks with Use of Bromocriptine Mesylate for Postpartum Lactation Inhibition or Suppression [see Warnings and Precautions (5.4)] Impulse Control Disorders and Compulsive Behaviors [see Warnings and Precautions (5.5)] Falling Asleep During Activities of Daily Living [see Warnings and Precautions (5.6)] Visual Impairment in Patients with Prolactin-secreting Adenomas [see Warnings and Precautions (5.7)] Exacerbation of Psychosis in Patients with Severe Psychotic Disorders [see Warnings and Precautions (5.8)] Risks in Patients with Hereditary Problems of Galactose Intolerance, Severe Lactase Deficiency, or Glucose-Galactose Malabsorption [see Warnings and Precautions (5.9)] Additional Clinically Significant Adverse Reactions and Risks in Patients with Acromegaly [see Warnings and Precautions (5.10)] Additional Clinically Significant Adverse Reactions and Risks in Patients with Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism [see Warnings and Precautions (5.11)] Most common adverse reactions: (6.1) Hyperprolactinemia-Associated …
Source: FDA drug label, ANI Pharmaceuticals, Inc., effective July 27, 2026 (SPL set 17f3a343-1782-4799-95ba-31dfe93be2cf), via openFDA; the full label on DailyMed
What do FAERS reports show?
646 reports list bromocriptine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 234 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bromocriptine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions