Medical Editor: John P. Cunha, DO, FACOEP
Dostinex (cabergoline) is a dopamine receptor antagonist used to treat a hormone imbalance in which there is too much prolactin in the blood (also called hyperprolactinemia). Common side effects of Dostinex include:
- nausea,
- vomiting,
- stomach upset or pain,
- indigestion,
- constipation,
- gas,
- dizziness,
- spinning sensation,
- lightheadedness,
- drowsiness,
- nervousness,
- tiredness,
- headache,
- depressed mood,
- hot flashes,
- numbness or tingly feeling, or
- dry mouth.
Tell your doctor if you experience rare but serious side effects of Dostinex including:
- shortness of breath,
- persistent cough,
- swelling ankles or feet,
- unusual tiredness,
- mental/mood changes (such as nervousness),
- unusual strong urges (such as increased gambling, increased sexual urges),
- vision changes,
- painful menses, or
- breast pain.
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. Breastfeeding 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.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using cabergoline and call your doctor at once if you have a serious side effect such as:
- feeling short of breath on exertion;
- chest discomfort, dry cough or hack;
- feeling weak or tired, loss of appetite, rapid weight loss;
- feeling like you might pass out;
- lower back pain;
- urinating less than usual or not at all; or
- swelling in your ankles or feet.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking cabergoline.
Less serious side effects may include:
- nausea, vomiting, stomach pain, gas, indigestion, constipation;
- headache, depressed mood;
- dizziness, spinning sensation;
- drowsiness, nervousness;
- hot flashes;
- numbness or tingly feeling; or
- dry mouth.
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 Dostinex (Cabergoline)
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).
Other events have been reported in association with cabergoline: hypersexuality, increased libido and 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)
Read the Dostinex User Reviews »
© Dostinex Patient Information is supplied by Cerner Multum, Inc. and Dostinex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
