Parlodel

Last updated on RxList: 7/22/2021
Parlodel Side Effects Center

What Is Parlodel?

Parlodel (bromocriptine mesylate) is a dopamine receptor agonist used to treat certain conditions caused by a hormone imbalance in which there is too much prolactin in the blood (hyperprolactinemia), and to treat these disorders when they are caused by brain tumors that can produce prolactin. Parlodel is sometimes used with surgery or radiation to treat acromegaly, and it is also used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Parlodel is available in generic form.

What Are Side Effects of Parlodel?

Common side effects of Parlodel include:

  • mild headache,
  • depression,
  • dizziness,
  • spinning sensation,
  • tired feeling,
  • drowsiness,
  • sleep problems (insomnia),
  • nausea,
  • vomiting,
  • upset stomach,
  • stomach pain,
  • loss of appetite,
  • diarrhea,
  • constipation,
  • cold feeling or numbness in your fingers,
  • dry mouth, or
  • stuffy nose.

Tell your doctor if you have serious side effects of Parlodel including:

  • vision problems,
  • constant runny nose,
  • chest pain,
  • pain when you breathe,
  • fast heart rate,
  • rapid breathing,
  • shortness of breath,
  • back pain,
  • swelling in your ankles or feet,
  • urinating less than usual or not at all,
  • confusion,
  • hallucinations,
  • feeling like you might pass out,
  • low blood sugar (headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating),
  • muscle movements you cannot control,
  • loss of balance or coordination,
  • bloody or tarry stools,
  • coughing up blood or vomit that looks like coffee grounds, or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Dosage for Parlodel

Parlodel should be taken with food. Patients are evaluated to determine the lowest dosage that produces a therapeutic response.

What Drugs, Substances, or Supplements Interact with Parlodel?

Parlodel may interact with metoclopramide, antidepressants, antibiotics, anti-malaria drugs, asthma or allergy medication, cancer medicine, cholesterol-lowering drugs, diabetes medication taken by mouth, ergot medicine, heart or blood pressure medications, heart rhythm medication, HIV or AIDS medications, medicines to treat psychiatric disorders, medicines used to prevent organ transplant rejection, sedatives or narcotics, or seizure medications. Tell your doctor all medications you are taking.

Parlodel During Pregnancy and Breastfeeding

Parlodel is not expected to be harmful to a fetus. However, a brain tumor can expand during pregnancy. Hypertension (high blood pressure) can also occur during pregnancy and Parlodel could be dangerous if taken by a pregnant woman with high blood pressure. Parlodel lowers the hormone needed to produce breast milk. Do not take this medication if you are breastfeeding a baby.

Additional Information

Our Parlodel (bromocriptine mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Fertility Options: Types, Treatments, and Costs See Slideshow
Parlodel Consumer Information

3 pharmacies near 20147 have coupons for Parlodel (Brand Names:Parlodel for 2.5MG)

Wegmans Food Markets Inc
Wegmans Food Markets Inc
$24.49

Est. Regular Price

$9.2

with free coupon

View Coupon

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • numbness, pain, and paleness or discoloration in your fingers or toes (especially in cold weather);
  • vision problems, constant runny nose;
  • chest pain, pain when you breathe, fast heart rate, rapid breathing, feeling short of breath (especially when lying down);
  • back pain, swelling in your ankles or feet, urinating less than usual or not at all;
  • confusion, hallucinations, feeling like you might pass out;
  • muscle movements you cannot control, loss of balance or coordination; or
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Parlodel may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • dizziness;
  • headache;
  • hallucinations;
  • nausea, constipation; or
  • abnormal involuntary movements.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Parlodel (Bromocriptine Mesylate)

QUESTION

Men and women are equally likely to have fertility problems. See Answer
Parlodel Professional Information

SIDE EFFECTS

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

The following adverse reactions have been reported during postapproval use of Parlodel (All Indications Combined). Because adverse reactions from spontaneous reports are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Psychiatric disorders: Confusion, psychomotor agitation/excitation, hallucinations, psychotic disorders, insomnia, libido increase, hypersexuality, and impulse control/compulsive behaviors (including gambling, spending, and other intense urges).

Nervous system disorders: Headache, drowsiness, dizziness, dyskinaesia, somnolence, paraesthesia, excess daytime somnolence, sudden onset of sleep.

Eye disorders: Visual disturbance, vision blurred.

Ear and labyrinth disorders: Tinnitus.

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

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)

Respiratory, thoracic and mediastinal disorders: Nasal congestion, pleural effusion, pleural fibrosis, pleurisy, pulmonary fibrosis, dyspnoea.

Gastrointestinal disorders: Nausea, constipation, vomiting, dry mouth, diarrhea, abdominal pain, retroperitoneal fibrosis, gastrointestinal ulcer, gastrointestinal hemorrhage.

Skin and subcutaneous tissue disorders: Allergic skin reactions, hair loss.

Musculoskeletal and connective tissue disorders: Leg cramps.

General disorders and administration site conditions: Fatigue, peripheral oedema, a syndrome resembling Neuroleptic Malignant Syndrome on abrupt withdrawal of Parlodel (see PRECAUTIONS).

Adverse Events Observed In Other Conditions

Postpartum Patients (See Above WARNINGS)

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 pregnancyinduced 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.

In rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, or psychic disorders have been reported in postpartum women treated with Parlodel. In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances. Although the causal relationship of these events to the drug is uncertain, periodic monitoring of blood pressure is advisable in postpartum women receiving Parlodel. If hypertension, severe, progressive, or unremitting headache (with or without visual disturbances), or evidence of CNS toxicity develop, the administration of Parlodel should be discontinued and the patient should be evaluated promptly.

Particular caution is required in patients who have recently been treated or are on concomitant therapy with drugs that can alter blood pressure, e.g., vasoconstrictors such as sympathomimetics or ergot alkaloids including ergometrine or methylergometrine and their concomitant use in the puerperium is not recommended.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

The risk of using Parlodel in combination with other drugs has not been systematically evaluated, but alcohol may potentiate the side effects of Parlodel. Parlodel may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of Parlodel: phenothiazines, haloperidol, metoclopramide, and pimozide. Bromocriptine is a substrate of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors of this enzyme (such as azole antimycotics, HIV protease inhibitors). The concomitant use of macrolide antibiotics such as erythromycin was shown to increase the plasma levels of bromocriptine (mean AUC and Cmax values increased 3.7-fold and 4.6- fold, respectively). The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine (bromocriptine AUC increased about 38%).4 Concomitant use of Parlodel with other ergot alkaloids is not recommended. Dose adjustment may be necessary in those cases where high doses of bromocriptine are being used (such as Parkinson's disease indication).

Read the entire FDA prescribing information for Parlodel (Bromocriptine Mesylate)

© Parlodel Patient Information is supplied by Cerner Multum, Inc. and Parlodel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors