Drug · FAERS side-effect profile with label screen
Pramipexole side effects: what 15,235 FDA adverse event reports show
Drug class
Non-ergot dopamine agonist
FDA label, Indications wording
Who reports
15,235 reports · 74% serious · 1,300 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PRAMIPEXOLE DIHYDROCHLORIDE tablets is a non-ergot dopamine agonist indicated for the treatment of • the signs and symptoms of idiopathic Parkinson's disease (PD) ( 1.1 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
FDA label, Indications and Usage
What it is
Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride a nonergot dopamine agonist.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 10Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 23
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,118 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Restless leg augmentation syndrome | 70 | 1,439.5 1,028.8–2,014.1ROR 1,446.1 · χ² 48,137 / p <1e-300 | 586.3 EB05 479.9 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=66 | not reported in cached trials |
| Dopamine agonist withdrawal syndrome | 24 | 1,163.3 674.6–2,006.3ROR 1,165.2 · χ² 14,388 / p <1e-300 | 417.5 EB05 295.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · ♀ 0% (drug 61%) · 100% clinician | not reported in cached trials |
| Parkinsonism hyperpyrexia syndrome | 45 | 455.8 325.3–638.6ROR 457.1 · χ² 14,948 / p <1e-300 | 298.2 EB05 232.0 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=45 · 100% clinician | not reported in cached trials |
| Encephalitis toxic | 17 | 366.2 214.4–625.6ROR 366.6 · χ² 4,593 / p <1e-300 | 218.1 EB05 144.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Gait spastic | 57 | 270.5 203.7–359.3ROR 271.5 · χ² 12,538 / p <1e-300 | 209.9 EB05 168.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 0% (drug 61%) | not reported in cached trials |
| Paraphilia | 17 | 204.2 122.7–339.9ROR 204.4 · χ² 2,814 / p <1e-300 | 148.4 EB05 98.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Dopamine dysregulation syndrome | 56 | 196.9 148.8–260.5ROR 197.6 · χ² 9,362 / p <1e-300 | 162.6 EB05 129.9 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=52 · ♀ 26% (drug 61%) · 100% clinician | not reported in cached trials |
| Restless arm syndrome | 19 | 192.4 119.1–311.1ROR 192.7 · χ² 3,004 / p <1e-300 | 144.5 EB05 97.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | not reported in cached trials |
| Needle fatigue | 56 | 191.9 145.2–253.8ROR 192.6 · χ² 9,152 / p <1e-300 | 159.2 EB05 127.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 0% (drug 61%) | not reported in cached trials |
| Jealous delusion | 32 | 174.4 120.8–251.9ROR 174.8 · χ² 4,737 / p <1e-300 | 141.8 EB05 105.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 35% (drug 61%) · 100% clinician | not reported in cached trials |
| Impulse-control disorder | 195 | 144.0 124.3–166.8ROR 145.8 · χ² 24,907 / p <1e-300 | 128.7 EB05 114.2 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=177 · ♀ 34% (drug 61%) | not reported in cached trials |
| Camptocormia | 22 | 139.5 90.0–216.3ROR 139.7 · χ² 2,619 / p <1e-300 | 114.3 EB05 79.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 80 | 131.6 104.7–165.5ROR 132.3 · χ² 9,334 / p <1e-300 | 116.8 EB05 96.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=80 · ♀ 88% (drug 61%) | not reported in cached trials |
| Congenital hiatus hernia | 18 | 121.5 75.1–196.8ROR 121.7 · χ² 1,866 / p <1e-300 | 100.1 EB05 67.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | not reported in cached trials |
| Relapsing-remitting multiple sclerosis | 62 | 106.5 82.3–137.9ROR 106.9 · χ² 5,912 / p <1e-300 | 96.0 EB05 77.6 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=62 · ♀ 0% (drug 61%) | not reported in cached trials |
| Malignant polyp | 13 | 101.4 57.7–178.1ROR 101.5 · χ² 1,111 / p 7e-244 | 83.3 EB05 51.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| On and off phenomenon | 356 | 99.8 89.7–111.0ROR 102.2 · χ² 32,354 / p <1e-300 | 92.6 EB05 84.8 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=332 | not reported in cached trials |
| Granuloma skin | 55 | 97.8 74.4–128.6ROR 98.2 · χ² 4,827 / p <1e-300 | 88.6 EB05 70.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Freezing phenomenon | 234 | 95.8 84.0–109.2ROR 97.3 · χ² 20,414 / p <1e-300 | 88.9 EB05 79.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=195 | not reported in cached trials |
| Hypersexuality | 115 | 92.0 76.2–111.1ROR 92.7 · χ² 9,613 / p <1e-300 | 85.1 EB05 72.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=103 · ♀ 22% (drug 61%) | not reported in cached trials |
| Pleurothotonus | 45 | 71.4 53.0–96.4ROR 71.6 · χ² 2,902 / p <1e-300 | 66.1 EB05 51.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | not reported in cached trials |
| Stereotypy | 46 | 71.0 52.8–95.5ROR 71.2 · χ² 2,952 / p <1e-300 | 65.8 EB05 51.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 35% (drug 61%) · 100% clinician | not reported in cached trials |
| Drug-genetic interaction | 16 | 70.5 42.7–116.5ROR 70.6 · χ² 977 / p 8e-215 | 62.3 EB05 40.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Stoma site reaction | 33 | 70.4 49.6–99.9ROR 70.6 · χ² 2,082 / p <1e-300 | 64.6 EB05 48.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=33 | not reported in cached trials |
| Stoma site erythema | 88 | 67.9 54.9–84.1ROR 68.3 · χ² 5,464 / p <1e-300 | 63.9 EB05 53.5 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=82 | not reported in cached trials |
| Penis injury | 17 | 67.5 41.5–109.8ROR 67.5 · χ² 998 / p 2e-219 | 60.2 EB05 39.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Cerebral hypoperfusion | 21 | 66.0 42.6–102.2ROR 66.1 · χ² 1,220 / p 1e-267 | 59.7 EB05 41.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Binge eating | 47 | 63.0 47.0–84.3ROR 63.2 · χ² 2,680 / p <1e-300 | 58.9 EB05 46.0 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=45 | not reported in cached trials |
| Total lung capacity decreased | 70 | 62.9 49.5–79.9ROR 63.2 · χ² 4,015 / p <1e-300 | 59.2 EB05 48.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 100% (drug 61%) | not reported in cached trials |
| Parkinsonian gait | 27 | 62.4 42.5–91.8ROR 62.5 · χ² 1,502 / p <1e-300 | 57.4 EB05 41.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=27 · 100% clinician | not reported in cached trials |
| Gambling | 49 | 59.6 44.8–79.4ROR 59.8 · χ² 2,651 / p <1e-300 | 56.0 EB05 44.0 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=45 · ♀ 35% (drug 61%) · 71% consumer | NCT01061567: 1/1,814 (0.1%) on Pramipexole (serious AE) |
| Compulsive shopping | 86 | 59.6 48.1–74.0ROR 60.0 · χ² 4,694 / p <1e-300 | 56.5 EB05 47.2 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=80 | not reported in cached trials |
| Euthanasia | 13 | 58.8 33.8–102.5ROR 58.9 · χ² 654 / p 2e-144 | 52.3 EB05 32.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Gambling disorder | 109 | 57.5 47.5–69.7ROR 57.9 · χ² 5,756 / p <1e-300 | 54.7 EB05 46.6 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=103 | NCT01061567: 1/1,814 (0.1%) on Pramipexole (serious AE) |
| Anticoagulant therapy | 11 | 56.8 31.1–103.7ROR 56.8 · χ² 526 / p 1e-116 | 50.1 EB05 29.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Reduced facial expression | 39 | 55.7 40.5–76.7ROR 55.9 · χ² 1,961 / p <1e-300 | 52.3 EB05 39.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 24% (drug 61%) | not reported in cached trials |
| Dropped head syndrome | 15 | 55.2 32.9–92.4ROR 55.2 · χ² 715 / p 6e-158 | 49.9 EB05 32.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Blood parathyroid hormone decreased | 57 | 54.7 42.0–71.2ROR 54.9 · χ² 2,836 / p <1e-300 | 51.7 EB05 41.4 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=57 · ♀ 100% (drug 61%) · 91% clinician | not reported in cached trials |
| Sleep attacks | 18 | 54.3 33.9–86.9ROR 54.4 · χ² 855 / p 3e-188 | 49.7 EB05 33.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pneumococcal infection | 22 | 53.6 35.0–82.1ROR 53.7 · χ² 1,043 / p 5e-229 | 49.5 EB05 34.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 61%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Pramipexole as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT01061567 — Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in (N=1814, phase n/a; 4 AE terms posted; arms: All Patients)
- NCT01100073 — Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Qualit (N=1703, phase n/a; 3 AE terms posted; arms: Mirapexin® (Pramipexole))
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,422 | 1.5 1.4–1.6ROR 1.5 · χ² 241 / p 1e-54 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Fall | 1,130 | 4.7 4.4–5.0ROR 5.0 · χ² 3,319 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | not reported in cached trials |
| Fatigue (tiredness) | 1,108 | 2.0 1.9–2.1ROR 2.0 · χ² 543 / p 2e-120 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | not reported in cached trials |
| Nausea | 870 | 1.5 1.4–1.6ROR 1.5 · χ² 159 / p 8e-37 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Pain | 831 | 1.9 1.7–2.0ROR 1.9 · χ² 339 / p 5e-76 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Condition aggravated | 824 | 3.8 3.5–4.0ROR 3.9 · χ² 1,689 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | not reported in cached trials |
| Hallucination (hallucinations) | 807 | 15.0 14.0–16.0ROR 15.8 · χ² 10,429 / p <1e-300 | 14.8 EB05 14.0 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 | not reported in cached trials |
| Off label use (used outside approved label) | 781 | 1.2 1.2–1.3ROR 1.3 · χ² 37 / p 5e-10 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Dizziness | 771 | 2.1 2.0–2.3ROR 2.2 · χ² 474 / p 3e-105 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 726 | 1.8 1.6–1.9ROR 1.8 · χ² 248 / p 4e-56 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Dyskinesia (involuntary movements) | 690 | 23.8 22.1–25.6ROR 24.9 · χ² 14,822 / p <1e-300 | 23.4 EB05 22.0 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.6 | not reported in cached trials |
| Gait disturbance | 669 | 4.8 4.5–5.2ROR 5.0 · χ² 2,027 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | not reported in cached trials |
| Headache | 621 | 1.4 1.3–1.5ROR 1.4 · χ² 62 / p 2e-15 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Tremor (shaking) | 612 | 5.1 4.7–5.5ROR 5.3 · χ² 2,011 / p <1e-300 | 5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | not reported in cached trials |
| Death | 606 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.216 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.8 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Restless leg augmentation syndrome — n=70, PRR 1,439.5
- Gait spastic — n=57, PRR 270.5
- Needle fatigue — n=56, PRR 191.9
- Jealous delusion — n=32, PRR 174.4
- Impulse-control disorder — n=195, PRR 144.0
- Camptocormia — n=22, PRR 139.5
- Bronchopulmonary aspergillosis allergic — n=80, PRR 131.6
- Granuloma skin — n=55, PRR 97.8
- Freezing phenomenon — n=234, PRR 95.8
- Hypersexuality — n=115, PRR 92.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Pramipexole (dopamine agonists) ↔ Impulse-control disorder.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pramipexole?
In FDA FAERS, the most frequently co-reported reaction terms for Pramipexole are fall, fatigue, nausea, pain, hallucination, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pramipexole have an FDA boxed warning?
No. The FDA label retrieved for Pramipexole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pramipexole causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID a7405a56-de1c-4875-b57f-210c991474ba, effective 20161013; matched on
openfda.generic_name.exact:"PRAMIPEXOLE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,158 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
PRAMIPEXOLE, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.