What the label lists and what reports show
Pramipexole side effects
Pramipexole's FDA label: “Most common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension …” FAERS holds 19,752 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,419 reports).
- Generic listed
Check it at the source: the pramipexole FDA label on DailyMed (effective March 31, 2026, Torrent Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of pramipexole dihydrochloride tablets?Pramipexole dihydrochloride tablets may cause serious side effects, including: falling asleep during normal daily activities. Pramipexole dihydrochloride tablets may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating. Some people taking the medicine in pramipexole dihydrochloride tabletshave had car accidents because they fell asleep while driving. Some patients did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning. Tell your doctor right away if you fall asleep while you are doing activities such as talking, eating, driving, or if you feel sleepier than normal for you. • low blood pressure when you sit or stand up quickly. You may have: dizziness nausea fainting sweating Sit and stand up slowly after you have been sitting or lying down. unusual urges. […]
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective March 31, 2026 (SPL set 60167d7c-469f-455a-a113-561841af5e59), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency […]
Table 4 Adverse-Reactions in Pooled Double-Blind, Placebo-Controlled Trials with Pramipexole Dihydrochloride Tablets in Early Parkinson's Disease
| Body System/ Adverse Reaction | Pramipexole Dihydrochloride Tablets (N=388) % | Placebo (N=235) % |
|---|---|---|
| Dizziness | 25 | 24 |
| Somnolence | 22 | 9 |
| Insomnia | 17 | 12 |
| Hallucinations | 9 | 3 |
| Confusion | 4 | 1 |
| Amnesia | 4 | 2 |
| Hypesthesia | 3 | 1 |
| Dystonia | 2 | 1 |
| Akathisia | 2 | 0 |
| Thinking abnormalities | 2 | 0 |
| Decreased libido | 1 | 0 |
| Myoclonus | 1 | 0 |
| Nausea | 28 | 18 |
| Constipation | 14 | 6 |
| Anorexia | 4 | 2 |
| Dysphagia | 2 | 0 |
| Asthenia | 14 | 12 |
| General edema | 5 | 3 |
| Malaise | 2 | 1 |
| Reaction unevaluable | 2 | 1 |
| Fever | 1 | 0 |
| Peripheral edema | 5 | 4 |
| Decreased weight | 2 | 0 |
| Vision abnormalities | 3 | 0 |
| Impotence | 2 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency ( 6.1 ) RLS: nausea, somnolence, fatigue, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h. The following adverse reactions are discussed in greater detail in other sections of the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.1 )]. Symptomatic Orthostatic Hypotension [see Warnings and Precautions ( 5.2 )]. Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.3 )]. Hallucinations and Psychotic-like Behavior [see Warnings and Precautions ( 5.4 )]. Dyskinesia [see Warnings and Precautions ( 5.5 )]. Postural Deformity [see Warnings and Precautions ( 5.6 )]. Rhabdomyolysis [see Warnings and Precautions ( 5.8 )]. Retinal Pathology [see Warnings and Precautions ( 5.9 )]. …
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective March 31, 2026 (SPL set 60167d7c-469f-455a-a113-561841af5e59), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,752 reports list pramipexole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,654 are coded as a death and 7,004 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pramipexole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions