Drug · FAERS side-effect profile with label screen
Pramipexole Dihydrochloride side effects: what 4,685 FDA adverse event reports show
Drug class
Non-ergot dopamine agonist
FDA label, Indications wording
Who reports
4,685 reports · 74% serious · 365 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pramipexole dihydrochloride extended- release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) ( 1 ) Pramipexole dihydrochloride extended- release tablets are indicated for the treatment of Parkinson's disease.
FDA label, Indications and Usage
What it is
Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot 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 5Labeled (related wording) 4Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 26
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.
- 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. 343 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 |
|---|---|---|---|---|---|---|
| Red blood cell sedimentation rate increased | 94 | 38.2 31.3–46.7ROR 39.0 · χ² 3,343 / p <1e-300 | 37.6 EB05 31.7 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 32.9 · ♀ 100% (drug 60%) | no trial data cached |
| Pulmonary fibrosis | 135 | 31.8 26.9–37.6ROR 32.7 · χ² 3,973 / p <1e-300 | 31.5 EB05 27.3 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.7 · ♀ 100% (drug 60%) | no trial data cached |
| Micturition urgency | 68 | 27.0 21.3–34.2ROR 27.4 · χ² 1,666 / p <1e-300 | 26.7 EB05 21.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 33.8 · ♀ 7% (drug 60%) | no trial data cached |
| Hypercalcaemia | 72 | 26.3 20.9–33.0ROR 26.7 · χ² 1,715 / p <1e-300 | 26.0 EB05 21.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 21.6 · ♀ 100% (drug 60%) | no trial data cached |
| Nocturia (night-time urination) | 66 | 24.5 19.3–31.2ROR 24.8 · χ² 1,457 / p <1e-300 | 24.2 EB05 19.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 32.4 · ♀ 0% (drug 60%) | no trial data cached |
| Restless legs syndrome | 92 | 22.7 18.5–27.8ROR 23.1 · χ² 1,880 / p <1e-300 | 22.5 EB05 18.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Sputum discoloured | 46 | 21.9 16.4–29.2ROR 22.1 · χ² 891 / p 4e-196 | 21.6 EB05 16.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 · ♀ 100% (drug 60%) | no trial data cached |
| Synovitis | 87 | 21.7 17.6–26.7ROR 22.1 · χ² 1,687 / p <1e-300 | 21.5 EB05 17.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 100% (drug 60%) | no trial data cached |
| Basal cell carcinoma | 74 | 21.3 17.0–26.7ROR 21.6 · χ² 1,405 / p <1e-300 | 21.1 EB05 17.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · ♀ 95% (drug 60%) | no trial data cached |
| Ulcer | 70 | 19.7 15.6–24.9ROR 20.0 · χ² 1,222 / p 6e-268 | 19.6 EB05 16.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · ♀ 100% (drug 60%) | no trial data cached |
| Drug eruption | 73 | 18.6 14.8–23.4ROR 18.9 · χ² 1,194 / p 6e-262 | 18.4 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 100% (drug 60%) | no trial data cached |
| Obstructive airways disorder | 46 | 18.5 13.9–24.7ROR 18.7 · χ² 742 / p 1e-163 | 18.3 EB05 14.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 91% (drug 60%) | no trial data cached |
| Aspiration | 44 | 18.2 13.6–24.5ROR 18.4 · χ² 697 / p 6e-154 | 18.0 EB05 13.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 95% (drug 60%) | no trial data cached |
| Prescribed underdose | 80 | 18.0 14.5–22.4ROR 18.3 · χ² 1,264 / p 4e-277 | 17.9 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 93% (drug 60%) | no trial data cached |
| Hallucination, visual | 84 | 18.0 14.5–22.2ROR 18.3 · χ² 1,325 / p 2e-290 | 17.8 EB05 14.8 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Ataxia | 42 | 15.8 11.7–21.4ROR 15.9 · χ² 566 / p 2e-125 | 15.6 EB05 11.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 6% (drug 60%) | no trial data cached |
| Delusion | 53 | 15.4 11.7–20.1ROR 15.5 · χ² 695 / p 2e-153 | 15.2 EB05 12.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · ♀ 29% (drug 60%) | no trial data cached |
| Dyskinesia (involuntary movements) | 136 | 15.0 12.7–17.8ROR 15.5 · χ² 1,767 / p <1e-300 | 14.9 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 | no trial data cached |
| Blood test abnormal | 45 | 14.4 10.7–19.2ROR 14.5 · χ² 545 / p 6e-121 | 14.1 EB05 10.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 16.6 · ♀ 95% (drug 60%) | no trial data cached |
| Diabetes mellitus inadequate control | 56 | 14.2 10.9–18.4ROR 14.3 · χ² 672 / p 2e-148 | 14.0 EB05 11.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 100% (drug 60%) · 93% clinician | no trial data cached |
| Muscle spasticity | 38 | 13.7 10.0–18.9ROR 13.8 · χ² 435 / p 6e-97 | 13.4 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 0% (drug 60%) | no trial data cached |
| Skin ulcer | 78 | 13.6 10.9–16.9ROR 13.8 · χ² 893 / p 2e-196 | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 97% (drug 60%) | no trial data cached |
| Muscle rigidity | 36 | 13.5 9.8–18.7ROR 13.6 · χ² 404 / p 5e-90 | 13.2 EB05 9.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.7 · ♀ 38% (drug 60%) | no trial data cached |
| Central nervous system lesion | 39 | 12.6 9.2–17.3ROR 12.7 · χ² 406 / p 2e-90 | 12.3 EB05 9.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 · ♀ 9% (drug 60%) | no trial data cached |
| C-reactive protein increased | 98 | 12.1 9.9–14.7ROR 12.3 · χ² 984 / p 2e-216 | 11.9 EB05 10.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 9.7 · ♀ 94% (drug 60%) | no trial data cached |
| Neuroleptic malignant syndrome | 32 | 12.1 8.5–17.0ROR 12.1 · χ² 313 / p 2e-70 | 11.6 EB05 8.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Adrenal insufficiency | 32 | 12.0 8.5–16.9ROR 12.1 · χ² 311 / p 8e-70 | 11.5 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · ♀ 0% (drug 60%) · 94% clinician | no trial data cached |
| Hallucination (hallucinations) | 189 | 11.3 9.8–13.0ROR 11.7 · χ² 1,767 / p <1e-300 | 11.2 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · ♀ 39% (drug 60%) | no trial data cached |
| Contraindicated product administered | 70 | 10.4 8.2–13.1ROR 10.5 · χ² 585 / p 2e-129 | 10.1 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · ♀ 100% (drug 60%) · 90% clinician | no trial data cached |
| Loss of personal independence in daily activities | 108 | 10.2 8.4–12.3ROR 10.4 · χ² 885 / p 1e-194 | 10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 90% (drug 60%) | no trial data cached |
| Dysarthria (slurred speech) | 85 | 10.1 8.2–12.5ROR 10.3 · χ² 690 / p 3e-152 | 9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 13% (drug 60%) | no trial data cached |
| Hyperthyroidism | 32 | 9.9 7.0–14.0ROR 10.0 · χ² 247 / p 5e-56 | 9.3 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 6% (drug 60%) · 100% clinician | no trial data cached |
| Infusion site pain | 27 | 9.5 6.5–13.8ROR 9.5 · χ² 196 / p 8e-45 | 8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=19 · ♀ 85% (drug 60%) · 78% consumer | no trial data cached |
| Hepatitis (liver inflammation) | 54 | 9.5 7.2–12.3ROR 9.6 · χ² 399 / p 4e-89 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 96% (drug 60%) | no trial data cached |
| Liver function test increased | 44 | 9.2 6.9–12.4ROR 9.3 · χ² 315 / p 9e-71 | 8.8 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · ♀ 100% (drug 60%) | no trial data cached |
| Musculoskeletal stiffness | 167 | 8.5 7.4–9.9ROR 8.8 · χ² 1,106 / p 9e-243 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 83% (drug 60%) | no trial data cached |
| Haemoptysis | 52 | 8.3 6.4–10.9ROR 8.4 · χ² 328 / p 1e-73 | 7.9 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 91% (drug 60%) | no trial data cached |
| Cognitive disorder | 86 | 8.3 6.7–10.2ROR 8.4 · χ² 544 / p 2e-120 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Therapeutic product effect decreased | 82 | 8.3 6.7–10.3ROR 8.4 · χ² 518 / p 7e-115 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.4 · ♀ 93% (drug 60%) | no trial data cached |
| Seasonal allergy | 26 | 8.3 5.6–12.1ROR 8.3 · χ² 158 / p 1e-36 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=19 · ♀ 88% (drug 60%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Headache | 298 | 2.1 1.9–2.4ROR 2.2 · χ² 183 / p 6e-42 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.6 · ♀ 86% (drug 60%) | no trial data cached |
| Pain | 298 | 2.2 1.9–2.4ROR 2.2 · χ² 192 / p 7e-44 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Fall | 283 | 3.8 3.4–4.3ROR 4.0 · χ² 593 / p 3e-131 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Insomnia (trouble sleeping) | 261 | 4.4 3.9–4.9ROR 4.6 · χ² 685 / p 2e-151 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Condition aggravated | 260 | 3.9 3.4–4.3ROR 4.0 · χ² 554 / p 8e-123 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Pneumonia (lung infection) | 253 | 3.5 3.1–3.9ROR 3.6 · χ² 457 / p 1e-101 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · ♀ 84% (drug 60%) | no trial data cached |
| Dizziness | 247 | 2.2 2.0–2.5ROR 2.3 · χ² 168 / p 9e-39 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Hypertension (high blood pressure) | 219 | 4.6 4.1–5.3ROR 4.8 · χ² 624 / p 5e-138 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 83% (drug 60%) | no trial data cached |
| Asthenia (weakness) | 206 | 2.5 2.1–2.8ROR 2.5 · χ² 179 / p 5e-41 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Arthralgia (joint pain) | 197 | 2.1 1.9–2.4ROR 2.2 · χ² 119 / p 6e-28 | 2.1 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.6 · ♀ 84% (drug 60%) | no trial data cached |
| Hallucination (hallucinations) | 189 | 11.3 9.8–13.0ROR 11.7 · χ² 1,767 / p <1e-300 | 11.2 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · ♀ 39% (drug 60%) | no trial data cached |
| Peripheral swelling | 184 | 5.4 4.7–6.2ROR 5.5 · χ² 654 / p 2e-144 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 89% (drug 60%) | no trial data cached |
| Tremor (shaking) | 178 | 4.8 4.1–5.5ROR 4.9 · χ² 534 / p 2e-118 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 176 | 6.4 5.6–7.4ROR 6.7 · χ² 807 / p 6e-178 | 6.3 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Product dose omission issue | 172 | 2.7 2.3–3.1ROR 2.8 · χ² 185 / p 2e-42 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial data cached |
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.
- Micturition urgency — n=68, PRR 27.0
- Hypercalcaemia — n=72, PRR 26.3
- Nocturia — n=66, PRR 24.5
- Restless legs syndrome — n=92, PRR 22.7
- Sputum discoloured — n=46, PRR 21.9
- Synovitis — n=87, PRR 21.7
- Basal cell carcinoma — n=74, PRR 21.3
- Ulcer — n=70, PRR 19.7
- Drug eruption — n=73, PRR 18.6
- Obstructive airways disorder — n=46, PRR 18.5
✓ 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 Dihydrochloride?
In FDA FAERS, the most frequently co-reported reaction terms for Pramipexole Dihydrochloride are headache, pain, fall, insomnia, pneumonia, 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 Dihydrochloride have an FDA boxed warning?
No. The FDA label retrieved for Pramipexole Dihydrochloride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pramipexole Dihydrochloride 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 1d2b1d2c-ae22-424a-bad7-ce24a817b042, effective 20250424; matched on
openfda.generic_name.exact:"PRAMIPEXOLE DIHYDROCHLORIDE") - 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, 383 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
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.