A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Dostinex Side Effects, and Drug Interactions - Cabergoline
Dostinex Side Effects, and Drug Interactions - 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 |
5 (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 ³1 % 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 |
| Respirator |
| Rhinitis |
2 (1) |
9 (4) |
| Vision |
| Abnormal Vision |
2 (1) |
2 (1) |
*Reported at ³1% 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.
DRUG INTERACTIONS
DOSTINEX should not be administered concurrently with D2-antagonists,
such as phenothiazines, butyrophenones, thioxanthines, or metoclopramide.
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