Parlodel Side Effects

Generic Name: bromocriptine

Please note - some side effects for Parlodel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Parlodel - for the Consumer

Parlodel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Parlodel:

Cold sensitivity in fingers and toes; constipation; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; indigestion; lightheadedness; loss of appetite; nausea; stomach cramps; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal involuntary movements; bloody or black, tarry stools; chest pain; depression; fainting; hallucinations; one-sided weakness; persistent, watery nasal discharge; progressive, severe headache; shortness of breath; ringing in the ears; seizures; slurred speech or trouble speaking; stomach pain; sudden confusion; sudden daytime sleepiness; sudden loss of coordination; vision changes; vomiting blood or a substance like coffee grounds.

Parlodel Side Effects - for the Professional

Parlodel

Adverse Reactions from Clinical Trials

Hyperprolactinemic Indications

The incidence of adverse effects is quite high (69%) but these are generally mild to moderate in degree. Therapy was discontinued in approximately 5% of patients because of adverse effects. These in decreasing order of frequency are: 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 slight hypotensive effect may accompany Parlodel® (bromocriptine mesylate) treatment. The occurrence of adverse reactions may be lessened by temporarily reducing dosage to ½ SnapTabs® tablet 2 or 3 times daily. A few cases of cerebrospinal fluid rhinorrhea have been reported in patients receiving Parlodel for treatment of large prolactinomas. This has occurred rarely, usually only in patients who have received previous transsphenoidal surgery, pituitary radiation, or both, and who were receiving Parlodel for tumor recurrence. It may also occur in previously untreated patients whose tumor extends into the sphenoid sinus.

Acromegaly

The most frequent adverse reactions encountered in acromegalic patients treated with Parlodel 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%).

      Less frequent adverse reactions (less than 2%) were: gastrointestinal bleeding, dizziness, exacerbation of Raynaud’s syndrome, headache and syncope. Rarely (less than 1%) 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 have been reported.

Parkinson’s Disease

In clinical trials in which Parlodel was administered with concomitant reduction in the dose of levodopa/carbidopa, the most common newly appearing 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 which may be encountered include: 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 may include elevations in blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase and uric acid, which are usually transient and not of clinical significance.

Adverse Reactions from Postmarketing Experience

Pleural and pericardial effusions, pleural, and pulmonary fibrosis or retroperitoneal fibrosis and constrictive pericarditis have been reported rarely in patients treated with Parlodel.

      Very rarely, a syndrome resembling Neuroleptic Malignant Syndrome has been reported on abrupt withdrawal of Parlodel.

      Blurred vision, dyskinesia, and psychomotor agitation/excitation have also occurred in postmarketing experiences.

Adverse Events Observed in Other Conditions

Postpartum Patients

In postpartum studies with Parlodel, 23 percent of postpartum patients treated had at least 1 side effect, but they were generally mild to moderate in degree. Therapy was discontinued in approximately 3% of patients. The most frequently occurring adverse reactions were: headache (10%), dizziness (8%), nausea (7%), vomiting (3%), fatigue (1.0%), syncope (0.7%), diarrhea (0.4%) and cramps (0.4%). Decreases in blood pressure (≥ 20 mm Hg systolic and ≥ 10 mm Hg diastolic) occurred in 28% of patients at least once during the first 3 postpartum days; these were usually of a transient nature. Reports of fainting in the puerperium may possibly be related to this effect. In postmarketing experience in the U.S., serious adverse reactions reported include 72 cases of seizures (including 4 cases of status epilepticus), 30 cases of stroke, and 9 cases of myocardial infarction among postpartum patients. Seizure cases were not necessarily accompanied by the development of hypertension. An unremitting and often progressively severe headache, sometimes accompanied by visual disturbance, often preceded by hours to days many cases of seizure and/or stroke. Most patients had shown no evidence of any of the hypertensive disorders of pregnancy including eclampsia, preeclampsia or pregnancy-induced hypertension. One stroke case was associated with sagittal sinus thrombosis, and another was associated with cerebral and cerebellar vasculitis. One case of myocardial infarction was associated with unexplained disseminated intravascular coagulation and a second occurred in conjunction with use of another ergot alkaloid. The relationship of these adverse reactions to Parlodel administration has not been established.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included nausea (18% to 49%), constipation (3% to 14%), vomiting (2% to 5%), abdominal cramps (5%), indigestion/dyspepsia (4%), anorexia (4%), diarrhea (3%), gastrointestinal bleeding (less than 2%), abdominal discomfort, anorexia, dry mouth, and peptic ulcers have been reported.

Nervous system

Nervous system side effects have included headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), and drowsiness/tiredness (3%). Other side effects occurring less frequently (less than 2%) have included faintness, vertigo, paresthesia, insomnia, decreased sleep requirement, heavy headedness, sluggishness, reduced tolerance to cold, asthenia, tingling of ears, and numbness. A syndrome resembling neuroleptic malignant syndrome has been reported on abrupt withdrawal of bromocriptine.

Cardiovascular

Syncope and symptomatic hypotension (decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively) have been reported in approximately 30% of postpartum patients.

Seizures and/or strokes have been reported with bromocriptine administration. Many of the patients experiencing seizures and/or strokes reported developing a continuous headache, often progressively severe, hours to days prior to the acute event. In addition, visual disturbances (blurred vision and transient cortical blindness) have been reported to also precede stroke and/or seizure events. If a patient experiences severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, bromocriptine therapy should be discontinued and the patient should be evaluated promptly.

Cardiovascular side effects have included postural/orthostatic hypotension (6%), digital vasospasm (3%), syncope (less than 2%), seizures, stroke, and myocardial infarction. Rare cardiovascular side effects including arrhythmia, pleural and pericardial effusions, constrictive pericarditis, ventricular tachycardia, bradycardia, and vasovagal attack have been reported.

A case of severe dilated cardiomyopathy has been reported in a 31-year-old African American female one month after initiating treatment of a microprolactinoma with bromocriptine 5 mg orally daily. An echocardiogram showed a markedly dilated left ventricle with severe reduction in the left-ventricular ejection fraction. The patient returned to NYHA Class I four weeks after bromocriptine was stopped.

Respiratory

Respiratory side effects have included nasal congestion (3%) and shortness of breath. Pulmonary infiltrates, pleural effusion, and thickening of the pleura have been reported with long-term administration (6 months to 36 months) of bromocriptine doses ranging from 20 mg to 100 mg daily. Upon termination of bromocriptine therapy, these changes slowly reverted towards normal.

Rare cases of cerebrospinal fluid rhinorrhea have been reported in patients who have received previous transphenoidal surgery and/or pituitary radiation, and who were receiving bromocriptine for tumor recurrence.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps, facial pallor, abnormal involuntary movements, ataxia, edema of the feet and ankles, and erythromelalgia.

Rare musculoskeletal side effects including tingling of fingers, cold feet, numbness, muscle cramps in feet and legs, and exacerbation of Raynaud's Syndrome have been reported during bromocriptine therapy.

Psychiatric

Parkinsonian patients may manifest mild degrees of dementia, therefore, caution should be used when treating such patients.

Bromocriptine, alone or in combination with levodopa, may cause hallucinations (visual or auditory). Hallucinations usually resolve with dosage reduction; occasionally, discontinuation of the drug is required. Rarely, after high doses, hallucinations have persisted for several weeks after discontinuation of the drug.

Psychiatric side effects have included delusional psychosis, paranoia, depression, anxiety, confusion, "on-off" phenomenon, and nightmares. High doses of bromocriptine may be associated with confusion and mental disturbances (hallucinations).

Ocular

Ocular side effects have included visual disturbance and blepharospasm. Secondary deterioration of visual field may develop in patients receiving treatment for hyperprolactinemia due to chiasmal herniation. The visual field defect may improve on reduction of bromocriptine dosage.

Genitourinary

Genitourinary side effects have included urinary frequency, urinary incontinence, and urinary retention.

Dermatologic

Dermatologic side effects have included mottling of skin and skin rash.

Other

Other side effects have included hair loss, alcohol potentiation, reduced tolerance to cold, tingling of the ears, sign and symptoms of ergotism such as tingling of the fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's syndrome.

Local

Local side effects have included retroperitoneal fibrosis in a few patients receiving long-term therapy (2 to 10 years) with bromocriptine in doses ranging from 30 to 140 mg daily.

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