Pramipexole: adverse event reports filed with FDA

3,883

reports as suspect product

0% of all reports · about 174 a year

413

reports, 12 months to June 2026

301 in the 12 months before

90.6%

marked serious by the reporter

70.7% across the class

6.1%

record death among outcomes, as reported

236 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Pramipexole reports recording the termmedian drug in nonergot dopamine agonist

1. Drug ineffectivethe medicine did not work as expected12.4%481
2. Condition aggravatedthe condition being treated got worse8.5%331
3. Dyskinesiainvoluntary movements8%310
4. Fatiguetiredness7%270
5. Painpain, site not specified6.5%252
6. Tremorshaking6.4%250
7. Restless legs syndrome6.3%244
8. Dizzinesslight-headedness or unsteadiness6.2%241
9. Off label useused for a purpose or in a way not on the label6.1%238
10. Falla fall5.9%228
11. Anxietyanxiety5.8%225
12. Hallucinationseeing or hearing things that are not there5.5%212
13. Somnolencedrowsiness5.2%203
14. Insomniadifficulty sleeping5.1%198
15. Oedema peripheralswelling of the legs, ankles or hands4.9%189
16. Impulse-control disorder4.8%185
17. Gait disturbancedifficulty walking4.6%177
18. Depressionlow mood4.5%174
19. Suicidal ideationthoughts of suicide4.4%171
20. Drug interactionan interaction between medicines4.3%168
21. Medication errora mistake in prescribing, dispensing or taking a medicine4.2%165
22. Constipationconstipation4.2%162
23. Nauseafeeling sick4.1%160
24. Dyspnoeashortness of breath3.9%153
25. Astheniaweakness or lack of energy3.9%151
26. Confusional stateconfusion3.7%145
27. Memory impairmentmemory problems3.5%137
28. Headachehead pain3.4%132
29. Balance disorderproblems with balance3.4%131
30. General physical health deteriorationgeneral decline in health3.3%129

Top 30 of 1,021 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the nonergot dopamine agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 19,168 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 20.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,883 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pramipexole is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the nonergot dopamine agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Pramipexole as a suspect or interacting product; reports listing it only as a concomitant medication (11,565) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.