Bromocriptineside effects

bromocriptine 5 MG Oral Capsule

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Valvulopathy and Pericardial Fibrosis Pleural, Pulmonary, and Retroperitoneal Fibrosis Hypotension/Orthostatic Hypotension Risks with Use of Bromocriptine Mesylate for Postpartum Lactation Inhibition or Suppression Impulse Control Disorders and Compulsive Behaviors Falling Asleep During Activities of Daily Living Visual Impairment in Patients with Prolactin-secreting Adenomas Exacerbation of Psychosis in Patients with Severe Psychotic Disorders Risks in Patients with Hereditary Problems of Galactose Intolerance, Severe Lactase Deficiency, or Glucose-Galactose Malabsorption Additional Clinically Significant Adverse Reactions and Risks in Patients with Acromegaly Additional Clinically Significant Adverse Reactions and Risks in Patients with Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism Most common adverse reactions: Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas: (incidence >5%) are nausea, headache, dizziness, fatigue, lightheadedness, and vomiting.

Acromegaly: (incidence >5%) are nausea, constipation, and postural/orthostatic hypotension. Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism: nausea, abnormal involuntary movements, hallucinations, confusion To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Studies of Patients with Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas Bromocriptine mesylate therapy was discontinued in approximately 5% of patients with hyperprolactinemia-associated dysfunctions. The most common adverse reactions in bromocriptine mesylate-treated patients with hyperprolactinemia-associated dysfunctions were nausea (49%), headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), vomiting (5%), abdominal cramps (4%), nasal congestion (3%), constipation (3%), diarrhea (3%) and drowsiness (3%). A few cases of cerebrospinal fluid rhinorrhea have been reported in bromocriptine mesylate-treated patients with large prolactinomas who have received previous transsphenoidal surgery, pituitary radiation, or both. Adverse Reactions in Studies of Patients with Acromegaly The most frequent adverse reactions in bromocriptine mesylate-treated patients with acromegaly were nausea (18%), constipation (14%), postural/orthostatic hypotension (6%), anorexia (4%), dry mouth/nasal stuffiness (4%), indigestion/dyspepsia (4%), digital vasospasm (3%), drowsiness/tiredness (3%) and vomiting (2%). Adverse reactions that occurred in less than 2% of bromocriptine mesylate-treated patients with acromegaly were gastrointestinal bleeding, dizziness, exacerbation of Raynaud’s syndrome, headache, and syncope. Adverse reactions that occured in less than 1% of bromocriptine mesylate-treated patients with acromegaly were hair loss, alcohol potentiation, faintness, lightheadedness, arrhythmia, ventricular tachycardia, decreased sleep requirement, visual hallucinations, lassitude, shortness of breath, bradycardia, vertigo, paresthesia, sluggishness, vasovagal attack, delusional psychosis, paranoia, insomnia, heavy headedness, reduced tolerance to cold, tingling of ears, facial pallor, and muscle cramps. Adverse Reactions in Studies of Patients with Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism In clinical trials in bromocriptine mesylate-treated patients with idiopathic Parkinson’s disease or postencephalitic parkinsonism where patients had a reduction in the levodopa/carbidopa dosage, the most common adverse reactions were nausea, abnormal involuntary movements, hallucinations, confusion, “on-off’’ phenomenon, dizziness, drowsiness, faintness/fainting, vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia, insomnia, depression, hypotension, shortness of breath, constipation, and vertigo. Less common adverse reactions in bromocriptine mesylate-treated patients with idiopathic Parkinson’s disease or postencephalitic parkinsonismwere anorexia, anxiety, blepharospasm, dry mouth, dysphagia, edema of the feet and ankles, erythromelalgia, epileptiform seizure, fatigue, headache, lethargy, mottling of skin, nasal stuffiness, nervousness, nightmares, paresthesia, skin rash, urinary frequency, urinary incontinence, urinary retention, and rarely, signs and symptoms of ergotism such as tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud’s syndrome. Abnormalities in laboratory tests in bromocriptine mesylate-treated patients with idiopathic or postencephalitic Parkinson’s disease may include elevations in blood urea nitrogen, ALT, AST, GGPT, CPK, alkaline phosphatase and uric acid, which are usually transient. Additional Adverse Reactions in Clinical Studies of Bromocriptine Mesylate During clinical trials, dizziness, drowsiness, faintness, fainting, and syncope have been reported early in the course of bromocriptine mesylate therapy.

6.2 Postmarketing

Experience The following adverse reactions have been identified during postapproval use of bromocriptine mesylate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: Pericardial effusion, constrictive pericarditis, tachycardia, bradycardia,arrhythmia, cardiac valve fibrosis.

Ear and labyrinth disorders: Tinnitus.

Eye disorders: Visual disturbance, vision blurred. General disorders and administration site conditions: Fatigue, peripheral edema.

Gastrointestinal disorders: Nausea, constipation, vomiting, dry mouth, diarrhea, abdominalpain, retroperitoneal fibrosis, gastrointestinal ulcer, gastrointestinal hemorrhage. Musculoskeletal and connective tissue disorders: Leg cramps.

Nervous system disorders: Headache, drowsiness, dizziness, dyskinesia, somnolence,paraesthesia, excess daytime somnolence, sudden onset of sleep. Respiratory, thoracic and mediastinal disorders: Nasal congestion, pleural effusion, pleuralfibrosis, pleurisy, pulmonary fibrosis, dyspnea.

Psychiatric disorders: Confusion, psychomotor agitation/excitation, hallucinations, psychoticdisorders, insomnia, libido increase, hypersexuality, and impulse control/compulsive behaviors(including gambling, spending, and other intense urges). Skin and subcutaneous tissue disorders: Allergic skin reactions, hair loss.

Vascular disorders: Hypotension, orthostatic hypotension (very rarely leading to syncope),reversible pallor of fingers and toes induced by cold (especially in patients with history of Raynaud's phenomenon).

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 27, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Warnings

Since hyperprolactinemia with amenorrhea/galactorrhea and infertility has been found in patients with pituitary tumors, a complete evaluation of the pituitary is indicated before treatment with bromocriptine. If pregnancy occurs during bromocriptine administration, careful observation of these patients is mandatory. Prolactin-secreting adenomas may expand and compression of the optic or other cranial nerves may occur, emergency pituitary surgery becoming necessary. In most cases, the compression resolves following delivery. Reinitiation of bromocriptine treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy. The safety of bromocriptine treatment during pregnancy to the mother and fetus has not been established. Bromocriptine has been associated with somnolence, and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported. Patients must be informed of this and advised not to drive or operate machines during treatment with bromocriptine. Patients who have experienced somnolence and/or an episode of sudden sleep onset must not drive or operate machines. Furthermore, a reduction of dosage or termination of therapy may be considered. Symptomatic hypotension can occur in patients treated with bromocriptine for any indication. In postpartum studies with bromocriptine, decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively, have been observed in almost 30% of patients receiving bromocriptine. On occasion, the drop in supine systolic pressure was as much as 50-59 mm of Hg. Since, especially during the first days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, particular care should be exercised when driving a vehicle or operating machinery. While hypotension during the start of therapy with bromocriptine occurs in some patients, in rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, have been reported in postpartum women treated with bromocriptine for the inhibition of lactation. Hypertension has been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy; seizures have also been reported both with and without the prior development of hypertension; stroke has been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated. Many of these patients experiencing seizures (including cases of status epilepticus) and/or strokes reported developing a constant and often progressively severe headache hours to days prior to the acute event. Some cases of strokes and seizures were also preceded by visual disturbances (blurred vision, and transient cortical blindness). Cases of acute myocardial infarction have also been reported. Although a causal relationship between bromocriptine administration and hypertension, seizures, strokes, and myocardial infarction in postpartum women has not been established, use of the drug for prevention of physiological lactation, or in patients with uncontrolled hypertension is not recommended. In patients being treated for hyperprolactinemia, bromocriptine should be withdrawn when pregnancy is diagnosed (see PRECAUTIONS: Hyperprolactinemic States ). In the event that bromocriptine is reinstituted to control a rapidly expanding macroadenoma (see PRECAUTIONS: Hyperprolactinemic States ) and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing bromocriptine must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When bromocriptine is being used to treat acromegaly or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of bromocriptine is considered to be medically contraindicated. Because of the possibility of an interaction between bromocriptine and other ergot alkaloids, the concomitant use of these medications is not recommended. Periodic monitoring of the blood pressure, particularly during the first weeks of therapy is prudent. If hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, drug therapy should be discontinued and the patient should be evaluated promptly. Particular attention should be paid to patients who have recently been treated or are on concomitant therapy with drugs that can alter blood pressure. Their concomitant use in the puerperium is not recommended. Among patients on bromocriptine, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis, have been reported. Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of bromocriptine therapy should be considered. In those instances in which bromocriptine treatment was terminated, the changes slowly reverted towards normal. In a few patients on bromocriptine, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g., back pain, edema of the lower limbs, impaired kidney function) should be watched in this category of patients. Bromocriptine medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.

Contraindications

Bromocriptine mesylate is contraindicated in patients with: History of cardiac valvular disorders or a history of pericardial fibrosis. History of pleural, pulmonary, or retroperitoneal fibrotic disorders. Uncontrolled hypertension. Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate tablets or capsules or sensitivity to other ergot alkaloids. Bromocriptine mesylate is contraindicated in patients with: History of cardiac valvular disorders or a history of pericardial fibrosis. History of pleural, pulmonary, or retroperitoneal fibrotic disorders Uncontrolled hypertension Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate tablets or capsules or sensitivity to other ergot alkaloids.

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