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Dostinex

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Dostinex

Dostinex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Dostinex (cabergoline) is used to treat a hormone imbalance in which there is too much prolactin in the blood (also called hyperprolactinemia). It is a dopamine receptor antagonist. Common side effects include nausea, vomiting, stomach upset, constipation, dizziness, lightheadedness, or tiredness.

The recommended starting dosage of Dostinex Tablets is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level. Dostinex may interact with metoclopramide, ACE inhibitors, beta-blockers, calcium channel blockers, diuretics (water pills), or other blood pressure medications. Tell your doctor all medications you use. During pregnancy, Dostinex should be used only when prescribed. It is unknown if this medication passes into breast milk. This medication may affect breast milk production. Breast-feeding while using this drug is not recommended.

Our Dostinex (cabergoline) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Dostinex in Detail - Patient Information: Side Effects

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

Stop using cabergoline and call your doctor at once if you have any of these serious side effects:

  • cough or trouble breathing; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, constipation;
  • headache;
  • dizziness, drowsiness, nervousness;
  • numbness or tingly feeling; or
  • hot flashes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dostinex (Cabergoline) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Dostinex Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach upset, constipation, dizziness, lightheadedness, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: shortness of breath, persistent cough, swelling ankles/feet, unusual tiredness, mental/mood changes (such as nervousness, compulsive behavior including urge to gamble), vision changes, painful menses, breast pain.

Get medical help right away if you have any serious side effects, including: chest pain, lower back/flank pain, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Dostinex (Cabergoline)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dostinex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The safety of DOSTINEX Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.

In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1.0 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.

Incidence of Reported Adverse Events During the 4-Week, Double-Blind, Placebo-Controlled Trial

Adverse Event* Cabergoline
(n=168)
0.125 to 1 mg two times a week
Placebo
(n=20)
Number (percent)
Gastrointestinal
  Nausea 45 (27) 4 (20)
  Constipation 16 (10) 0
  Abdominal pain 9 (5) 1 (5)
  Dyspepsia 4 (2) 0
  Vomiting 4 (2) 0
Central and Peripheral Nervous System
  Headache 43 (26) 5 (25)
  Dizziness 25 (15) 1 (5)
  Paresthesia 2 (1) 0
  Vertigo 2 (1) 0
Body As a Whole
  Asthenia 15 (9) 2 (10)
  Fatigue 12 (7) 0
  Hot flashes 2 (1) 1 (5)
Psychiatric
  Somnolence 9 (5) 1 (5)
  Depression 5 (3) 1 (5)
  Nervousness 4 (2) 0
Autonomic Nervous System
  Postural hypotension 6 (4) 0
Reproductive - Female
  Breast pain 2 (1) 0
  Dysmenorrhea 2 (1) 0
Vision
  Abnormal vision 2 (1) 0
*Reported at ≥ 1% for cabergoline

In the 8-week, double-blind period of the comparative trial with bromocriptine, DOSTINEX (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from DOSTINEX were headache, nausea and vomiting (3, 2 and 2 patients respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.

Incidence of Reported Adverse Events During the 8-Week, Double-Blind Period of the Comparative Trial With Bromocriptine

Adverse Event* Cabergoline
(n=221)
Bromocriptine
(n=231)
Number (percent)
Gastrointestinal
  Nausea 63 (29) 100 (43)
  Constipation 15 (7) 21 (9)
  Abdominal pain 12 (5) 19 (8)
  Dyspepsia 11 (5) 16 (7)
  Vomiting 9 (4) 16 (7)
  Dry mouth 5 (2) 2 (1)
  Diarrhea 4 (2) 7 (3)
  Flatulence 4 (2) 3 (1)
  Throat irritation 2 (1) 0
  Toothache 2 (1) 0
Central and Peripheral Nervous System
  Headache 58 (26) 62 (27)
  Dizziness 38 (17) 42 (18)
  Vertigo 9 (4) 10 (4)
  Paresthesia 5 (2) 6 (3)
Body As a Whole
  Asthenia 13 (6) 15 (6)
  Fatigue 10 (5) 18 (8)
  Syncope 3 (1) 3 (1)
  Influenza-like symptoms 2 (1) 0
  Malaise 2 (1) 0
  Periorbital edema 2 (1) 2 (1)
  Peripheral edema 2 (1) 1
Psychiatric
  Depression 7 (3) 5 (2)
  Somnolence 5 (2) 5 (2)
  Anorexia 3 (1) 3 (1)
  Anxiety 3 (1) 3 (1)
  Insomnia 3 (1) 2 (1)
  Impaired concentration 2 (1) 1
  Nervousness 2 (1) 5 (2)
Cardiovascular
  Hot flashes 6 (3) 3 (1)
  Hypotension 3 (1) 4 (2)
  Dependent edema 2 (1) 1
  Palpitation 2 (1) 5 (2)
Reproductive - Female
  Breast pain 5 (2) 8 (3)
  Dysmenorrhea 2 (1) 1
Skin and Appendages
  Acne 3 (1) 0
  Pruritus 2 (1) 1
Musculoskeletal
  Pain 4 (2) 6 (3)
  Arthralgia 2 (1) 0
Respiratory
  Rhinitis 2 (1) 9 (4)
Vision
  Abnormal vision 2 (1) 2 (1)
*Reported at ≥ 1% for cabergoline

Other adverse events that were reported at an incidence of < 1.0% in the overall clinical studies follow.

Body As a Whole: facial edema, influenza-like symptoms, malaise

Cardiovascular System: hypotension, syncope, palpitations

Digestive System: dry mouth, flatulence, diarrhea, anorexia

Metabolic and Nutritional System: weight loss, weight gain

Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety

Respiratory System: nasal stuffiness, epistaxis

Skin and Appendages: acne, pruritus

Special Senses: abnormal vision

Urogenital System: dysmenorrhea, increased libido

The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson's disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson's disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.

Postmarketing Surveillance data

The following events have been reported in association with DOSTINEX: cardiac valvulopathy and extracardiac fibrotic reactions, (See WARNINGS, Cardiac Valvulopathy and Extracardiac Fibrotic Reactions).

Others events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (See PRECAUTIONS, Psychiatric). In addition, cases of alopecia, aggression and psychotic disorder have been reported in patients taking DOSTINEX. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.

Read the entire FDA prescribing information for Dostinex (Cabergoline) »

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Dostinex - User Reviews

Dostinex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Dostinex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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