Parlodel Side Effects
Generic name: bromocriptine
Medically reviewed by Drugs.com. Last updated on Jul 20, 2024.
Note: This document provides detailed information about Parlodel.
Applies to bromocriptine: oral capsule, oral tablet Side Effects associated with bromocriptine. Some dosage forms listed on this page may not apply specifically to the brand name Parlodel.
Applies to bromocriptine: oral capsule, oral tablet.
Precautions
It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
For females using Parlodel® who are not trying to get pregnant:
- Use an effective form of birth control (other than oral contraceptives) to keep from getting pregnant. A pregnancy test is needed every 4 weeks during the amenorrheic period or every time you miss a monthly period. If you think you have become pregnant while using the medicine, tell your doctor right away.
- Check with your doctor right away if you develop blurred vision, a sudden headache, or severe nausea and vomiting.
Do not use Cycloset® if you had recently given birth to a child (postpartum). This medicine may cause serious and life-threatening problems when given to postpartum women, including high blood pressure, heart attack, seizures, stroke, or mental illness.
This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or when the dose is increased.
Parlodel® may increase your risk of having a condition called retroperitoneal fibrosis. This is more likely to occur if you are receiving this medicine on high doses and have been using it for a long time. Check with your doctor if you have continuing or severe stomach pain, increased frequency of urination, continuing loss of appetite, lower back pain, continuing or severe nausea and vomiting, or weakness while taking this medicine.
It is very important to follow carefully any instructions from your health care team about taking Cycloset®:
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.
Too much Cycloset® can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). People may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty in thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.
High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.
If symptoms of high blood sugar occur, check your sugar level and then call your doctor for instructions.
Bromocriptine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
It may take several weeks for bromocriptine (the active ingredient contained in Parlodel) to work. Do not Stop taking bromocriptine or reduce the amount you are taking without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This will decrease your chance of having withdrawal symptoms including anxiety, depression, difficulty in breathing, fast heartbeat, high fever, high or low blood pressure, lack of feeling or emotion, loss of bladder control, seizures, severe muscle stiffness, sweating, trouble sleeping, unusually pale skin, or unusual tiredness or weakness.
Drinking alcohol while you are taking bromocriptine may cause you to have a certain reaction. Avoid alcoholic beverages until you have discussed this with your doctor. Some of the symptoms you may have if you drink any alcohol while you are taking this medicine are blurred vision, chest pain, confusion, fast or pounding heartbeat, flushing or redness of the face, nausea, severe weakness, sweating, throbbing headache, or vomiting.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling, compulsive shopping, or increased sex drive while using this medicine.
It is important that your doctor check you for melanoma (skin cancer) regularly if you have Parkinson's disease.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Parlodel
Along with its needed effects, bromocriptine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking bromocriptine:
More common side effects
- blurred vision
- chest pain or discomfort
- difficulty in speaking
- dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position
- double vision
- feeling, seeing, or hearing things that are not there
- feeling of constant movement of self or surroundings
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- lack or loss of strength
- nausea
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- sensation of spinning
- severe mood or mental changes
- shakiness and unsteady walk
- slow or fast heartbeat
- slow speech
- sweating
- trouble breathing
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual behavior
- vomiting
Less common—reported more often in patients with Parkinson's disease
- confusion
- uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body
Rare—reported more often in patients taking large doses
- increased frequency of urination
- loss of appetite, continuing
- lower back pain
- runny nose, continuing
- stomach pain, continuing or severe
- weakness
Rare side effects
- black, tarry stools
- bloody vomit
- fainting
- nausea
- nervousness
- seizures
- sudden weakness
- temporary blindness
- unusual headache
- vomiting, continuing or severe
Incidence not known
- agitation
- anxiety
- blue or pale skin
- chest pain, possibly moving to the left arm, neck, or shoulder
- chills
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- cough
- diarrhea
- difficulty in speaking
- double vision
- false beliefs that cannot be changed by facts
- fever
- headache
- hearing loss
- heartburn
- high fever
- high or low blood pressure
- inability to move the arms, legs, or facial muscles
- inability to speak
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased frequency of urination
- indigestion
- loss of bladder control
- lower back pain
- severe muscle stiffness
- stuffy nose
- unusual tiredness or weakness
- unusually pale skin
- vomiting of blood or material that looks like coffee grounds
Other side effects of Parlodel
Some side effects of bromocriptine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common side effects
- drowsiness
- dry mouth
- leg cramps at night
- loss of appetite
- mental depression
- stomach pain
- tingling or pain in the fingers and toes when exposed to cold temperatures
Incidence not known
- hair loss
For healthcare professionals
Applies to bromocriptine: compounding powder, oral capsule, oral tablet.
General adverse events
The incidence of adverse reactions with this drug are high, but generally mild to moderate in degree. The most commonly reported adverse reactions have included nausea, headache, dizziness, vomiting, and fatigue.[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (up to 49%), constipation (12.5%)
- Common (1% to 10%): Dyspepsia, vomiting, abdominal cramps, diarrhea
- Frequency not reported: Severe gastrointestinal bleeding from peptic ulcers (including fatalities), dry mouth
- Postmarketing reports: Retroperitoneal fibrosis, gastrointestinal ulcer[Ref]
Retroperitoneal fibrosis has been reported in a few patients receiving this drug in doses ranging from 30 to 140 mg/day for 2 to 10 years.[Ref]
Cardiovascular
- Common (1% to 10%): Syncope, hypotension, orthostatic hypotension, cold-sensitive digital vasospasm
- Rare (0.01% to 0.1%): Hypertension
- Frequency not reported: Myocardial infarction, arrhythmia, ventricular tachycardia, bradycardia, ankle and feet edema, signs and symptoms of ergotism (e.g., tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's syndrome)
- Postmarketing reports: Cardiac valvulopathy, pericarditis, pericardial effusions, constrictive pericarditis, cardiac valve fibrosis[Ref]
Symptomatic hypotension has been reported in patients receiving this drug for any indication. 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. Rare cases of serious adverse events including hypertension, myocardial infarction, seizures, and strokes, have been reported in postpartum women. Patients experiencing seizures and/or strokes have 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.
Type 2 diabetes mellitus trials: Syncope was reported in 1.5% of patients; the cause of syncope was not known in all cases. In a 52-week safety trial in which all serious adverse events and cardiovascular endpoints were adjudicated, serious adverse events occurred in 8.5% of drug treated patients compared with 9.6% of placebo patients. The composite cardiovascular endpoint occurred in 31 (1.5%) drug-treated patients and 30 (3%) placebo patients.
Fibrotic complications including cases of retroperitoneal fibrosis, pulmonary fibrosis, pleural effusion, pleural thickening, pericarditis, and pericardial effusions have been reported during postmarketing period. These reports have been more commonly received in patients on long-term and high-dose treatment.[Ref]
Psychiatric
- Frequency not reported: Insomnia, paranoia, depression, anxiety, nervousness, nightmares, "on-off" phenomenon
- Postmarketing reports: Hallucinations, mental confusion, psychomotor agitation/excitation, increased libido, hypersexuality, pathological gambling, increased sexual urges, intense urges to spend money uncontrollably, other intense urges[Ref]
This drug, 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.[Ref]
Nervous system
- Very common (10% or more): Headache (up to 19%), Dizziness (up to 17%)
- Common (1% to 10%): Somnolence, lightheadedness, dyskinesia, ataxia
- Frequency not reported: Cerebrospinal fluid rhinorrhea, paresthesia, vasovagal attack, seizures
- Postmarketing reports: Stroke, neuroleptic-like malignant syndrome upon cessation in patients with Parkinson's disease, sudden sleep onset[Ref]
A few cases of cerebrospinal fluid rhinorrhea have been reported in patients with large prolactinomas who have received previous transsphenoidal surgery, pituitary radiation, or both. It may also occur in previously untreated patients whose tumor extends into the sphenoid sinus.[Ref]
Respiratory
- Very common (10% or more): Rhinitis (up to 13.8%), sinusitis (10%)
- Common (1% to 10%): Nasal congestion
- Frequency not reported: Shortness of breath, nasal stuffiness
- Postmarketing reports: Pulmonary fibrosis, pleural effusion, pleural thickening, pleural fibrosis, pleurisy, dyspnea[Ref]
Fibrotic complications including cases of retroperitoneal fibrosis, pulmonary fibrosis, pleural effusion, pleural thickening, pericarditis, and pericardial effusions have been reported during postmarketing approval use of this drug. These reports have been more commonly received in patients on long-term and high-dose treatment.[Ref]
Ocular
- Common (1% to 10%): Amblyopia
- Frequency not reported: Blepharospasm
- Postmarketing reports: Visual disturbance, vision blurred[Ref]
Musculoskeletal
- Frequency not reported: Muscle cramps
- Postmarketing reports: Leg cramps[Ref]
Genitourinary
- Frequency not reported: Urinary frequency, urinary incontinence, urinary retention[Ref]
Dermatologic
- Frequency not reported: Hair loss, erythromelalgia, mottling of skin, skin rash
- Postmarketing reports: Allergic skin reactions[Ref]
Other
- Very common (10% or more): Asthenia (up to 18.9%), fatigue (up to 13.9%)
- Frequency not reported: Vertigo, sluggishness, lassitude, alcohol potentiation
- Postmarketing reports: Tinnitus[Ref]
Hypersensitivity
- Postmarketing reports: Allergic skin reactions
Endocrine
- Frequency not reported: Growth hormone-secreting tumor expansion in patients with acromegaly
Immunologic
- Common (1% to 10%): Infection, flu syndrome
Metabolic
- Common (1% to 10%): Anorexia, hypoglycemia
In the monotherapy trial in patients with type 2 diabetes mellitus, hypoglycemia was reported in 2 patients (3.7%). In the add-on to sulfonylurea trials, hypoglycemia was reported in 8.6% of patients.
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References
1. (2018) "Product Information. Cycloset (bromocriptine)." Valeant Pharmaceuticals
2. (2001) "Product Information. Parlodel (bromocriptine)." Sandoz Pharmaceuticals Corporation
3. Larrazet F, Spaulding C, Lobreau HJ, Weber S, Guerin F (1993) "Possible bromocriptine-induced myocardial infarction." Ann Intern Med, 118, p. 199-200
4. Champagne SP, Coste E, Peyriere H, Nigond J, Mania E, Pons M, HillaireBuys D, Balmes P, Blayac JP, Davy JM (1999) "Chronic constrictive pericarditis induced by long-term bromocriptine therapy: Report of two cases." Ann Pharmacother, 33, p. 1050-4
5. Kaushik P, Vatsavai SR, Banda VR, Sanghi PK, Ahmad M, Kaushik R (2004) "Acute onset of severe dilated cardiomyopathy during bromocriptine therapy." Ann Pharmacother, 38, p. 1219-21
6. Peter SA, Autz A, Jean-Simon ML (1993) "Bromocriptine-induced schizophrenia." J Natl Med Assoc, 85, p. 700-1
7. Dorevitch A, Aronzon R, Stark M (1991) "Psychotic exacerbation attributed to low-dose bromocriptine treatment of galactorrhea and hyperprolactinemia." Acta Obstet Gynecol Scand, 70, p. 375-6
8. Boyd A (1995) "Bromocriptine and psychosis: a literature review." Psychiatr Q, 66, p. 87-95
9. Bende M, Bergman B, Sjogren C (1993) "Nasal mucosal congestion after treatment with bromocriptine." Laryngoscope, 103, p. 1142-4
10. Couldwell WT, Weiss MH (1992) "Visual loss associated with bromocriptine." Lancet, 340, p. 1210-411
11. Leiguarda R, Merello M, Sabe L, Starkstein S (1993) "Bromocriptine-induced dystonia in patients with aphasia and hemiparesis." Neurology, 43, p. 2319-22
12. Fabre N, Montastruc JL, Rascol O (1993) "Alopecia: an adverse effect of bromocriptine." Clin Neuropharmacol, 16, p. 266-8
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Further information
Parlodel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.