FDA Adverse Events Reports (FAERS) Summary for DOSTINEX

These tables and charts are based on 1,860 total reports for DOSTINEX (CABERGOLINE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 1,856 pharmaceutical company-submitted and non-U.S. FAERS reports and 4 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

Top 20 Adverse Effects Associated with DOSTINEX (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	HEADACHE	225
2	FATIGUE	180
3	DRUG INEFFECTIVE	162
4	DIZZINESS	152
5	NAUSEA	124
6	BLOOD PRESSURE INCREASED	121
7	DIARRHEA	113
8	SHORTNESS OF BREATH	97
9	MALAISE	95
10	JOINT PAIN	89
11	PAIN	86
12	BLOOD PROLACTIN INCREASED	83
13	DEPRESSION	82
14	PAIN IN EXTREMITY	81
15	LACK OF STRENGTH AND ENERGY (ASTHENIA)	78
16	WEIGHT INCREASED	66
17	ANXIETY	65
18	ABDOMINAL PAIN	64
19	INJECTION SITE PAIN	64
20	VOMITING	64
21	COUGH	63
22	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	63
23	BACK PAIN	61
24	FEELING ABNORMAL	58
25	DRUG EXPOSURE DURING PREGNANCY	57
26	ANEMIA	56
27	CHEST PAIN	56
28	NEEDLE ISSUE	56
29	HEART RATE INCREASED	55
30	DIABETES MELLITUS	53
31	ABDOMINAL DISTENSION	52
32	COMMON COLD	52
33	BLOOD GLUCOSE INCREASED	51
34	INSULIN-LIKE GROWTH FACTOR INCREASED	51
35	CONSTIPATION	50
36	MATERNAL EXPOSURE DURING PREGNANCY	50
37	HIGH BLOOD PRESSURE	49
38	OFF LABEL USE	48
39	WEIGHT DECREASED	48
40	ABDOMINAL PAIN UPPER	47
41	SKIN REDNESS	47
42	HEART RATE DECREASED	46
43	FAINTING	46
44	LOW BLOOD PRESSURE	45
45	DROWSINESS	45
46	EXCESS SWEATING	44
47	NUMBNESS	44
48	STRESS	41
49	DRUG INTERACTION	40
50	ITCHING	40
51	FEVER	40
52	MISCARRIAGE	39
53	FALL	39
54	PITUITARY TUMOUR BENIGN	39
55	HAIR LOSS	38
56	BLOOD PRESSURE HIGH	38
57	SLEEP APNEA	38
58	TREMOR	38
59	THROAT PAIN	37
60	PALPITATIONS	37
61	INSOMNIA	36
62	LOWER LIMBS SWELLING	36
63	BLOOD PRESSURE DECREASED	35
64	FLATULENCE	35
65	MUSCLE SPASMS	35
66	SWELLING OF LIMBS	35
67	GALLSTONES	33
68	BLOOD GROWTH HORMONE INCREASED	32
69	CONFUSIONAL STATE	32
70	GAIT DISTURBANCE	32
71	HOT FLUSH	32
72	MUSCLE PAIN	32
73	PITUITARY TUMOUR	32
74	CONDITION AGGRAVATED	31
75	DECREASED APPETITE	31
76	MOVEMENT DISORDER	31
77	SWELLING	31
78	CHEST DISCOMFORT	30
79	MEMORY IMPAIRMENT	30
80	SLEEP DISORDER	30
81	BRAIN TUMOUR	29
82	INSULIN-LIKE GROWTH FACTOR DECREASED	28
83	THERAPEUTIC RESPONSE DECREASED	28
84	BLINDNESS	27
85	NECK PAIN	27
86	CANCER MALIGNANT	27
87	RAPID HEART RATE (TACHYCARDIA)	27
88	FAECES DISCOLOURED	26
89	HYPERSENSITIVITY	26
90	CANCER PROGRESSION	26
91	PINS AND NEEDLES	26
92	VISUAL IMPAIRMENT	26
93	NOCTURIA	25
94	CONCOMITANT DISEASE AGGRAVATED	24
95	NERVOUSNESS	24
96	PRODUCT USE ISSUE	24
97	RUNNY NOSE	24
98	ANGINA ATTACK	23
99	OSTEOARTHRITIS	23
100	PREGNANCY	23

Latest Known Outcomes for Reactions Reported for DOSTINEX

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	680
2	Patient recovered	457
3	Patient has not recovered/symtoms have not resolved	387
4	Patient is recovering/symptoms resolving	225
5	Patient died	34
6	Patient has recovered but has consequent health issues	17

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	70
2005	77
2006	79
2007	89
2008	70
2009	65
2010	120
2011	82
2012	75
2013	94
2014	81
2015	117
2016	112
2017	119
2018	97
2019	95
2020	88
2021	64
2022	54
2023	96
2024	48
2025	43
2026	25

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	16
11-20	44
21-30	201
31-40	276
41-50	269
51-60	204
61-70	140
71-80	65
81-90	31
91+	6

Based on 1252 reports that included a patient age.

DOSTINEX Total Reports

Male	Female	Unknown	Total
502	1226	132	1,860

Top Countries Reporting

	Country	Number of Reports
1	Canada	219
2	France	202
3	Brazil	166
4	United States	129
5	Italy	78
6	Germany	37
7	Russia	29
8	EU	28
9	Spain	25
10	Poland	18

Outcomes for Reports

Serious: 1708
Not Serious: 151
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Lactation inhibition therapy
Pituitary tumour benign
Pituitary hyperplasia

Top Companies Reporting

PFIZER

Safety-Related FDA Updates

FDA Approval Date: 1996-12-23

DOSTINEX (CABERGOLINE) Brand name discontinued; available as generic:
Safety-related Labeling Changes

Have experience (good or bad) with DOSTINEX? Rate DOSTINEX at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for DOSTINEX reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.