Drug · FAERS side-effect profile with label screen
Rotigotine side effects: what 4,587 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
4,587 reports · 92% serious · 1,312 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 1No label text to screen 39
What the badges mean
- 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.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 999 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 |
|---|---|---|---|---|---|---|
| Dopamine agonist withdrawal syndrome | 12 | 431.5 226.4–822.3ROR 431.8 · χ² 3,640 / p <1e-300 | 217.6 EB05 132.6 · IC025 +3.6 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Parkinsonian crisis | 20 | 355.1 217.7–579.1ROR 355.6 · χ² 5,383 / p <1e-300 | 224.2 EB05 153.2 · IC025 +4.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Neuroprosthesis implantation | 19 | 248.4 152.7–404.1ROR 248.7 · χ² 3,784 / p <1e-300 | 175.0 EB05 118.4 · IC025 +4.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Restless leg augmentation syndrome | 20 | 248.0 154.3–398.4ROR 248.3 · χ² 3,988 / p <1e-300 | 176.3 EB05 120.5 · IC025 +4.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site extravasation | 36 | 147.9 105.0–208.4ROR 148.3 · χ² 4,631 / p <1e-300 | 125.4 EB05 94.7 · IC025 +5.0 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site induration | 11 | 147.9 79.5–274.9ROR 148.0 · χ² 1,325 / p 2e-290 | 109.3 EB05 65.1 · IC025 +3.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site odour | 20 | 142.4 90.0–225.4ROR 142.6 · χ² 2,428 / p <1e-300 | 115.6 EB05 79.0 · IC025 +4.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Dropped head syndrome | 33 | 135.2 94.7–193.1ROR 135.5 · χ² 3,897 / p <1e-300 | 115.6 EB05 86.1 · IC025 +4.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Parkinsonism hyperpyrexia syndrome | 15 | 131.5 77.5–223.1ROR 131.7 · χ² 1,663 / p <1e-300 | 104.9 EB05 67.5 · IC025 +3.8 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site hypergranulation | 49 | 122.6 91.6–164.0ROR 123.0 · χ² 5,333 / p <1e-300 | 108.3 EB05 85.2 · IC025 +5.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| On and off phenomenon | 383 | 114.4 103.2–126.8ROR 117.5 · χ² 39,792 / p <1e-300 | 105.5 EB05 96.9 · IC025 +6.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site inflammation | 50 | 105.1 78.9–140.0ROR 105.5 · χ² 4,709 / p <1e-300 | 94.6 EB05 74.6 · IC025 +5.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Dopamine dysregulation syndrome | 29 | 101.0 69.3–147.1ROR 101.2 · χ² 2,590 / p <1e-300 | 89.0 EB05 65.0 · IC025 +4.6 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Deep brain stimulation | 37 | 99.1 71.0–138.2ROR 99.3 · χ² 3,270 / p <1e-300 | 88.6 EB05 67.2 · IC025 +4.8 3/3 methods agree | No label text to screen | – | NCT00501969: 3/395 (0.8%) on Rotigotine (serious AE) |
| Stoma site erythema | 115 | 95.5 79.2–115.3ROR 96.3 · χ² 10,001 / p <1e-300 | 88.4 EB05 75.6 · IC025 +5.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Reduced facial expression | 61 | 94.5 73.0–122.4ROR 94.9 · χ² 5,210 / p <1e-300 | 86.4 EB05 69.7 · IC025 +5.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site reaction | 40 | 91.5 66.5–125.8ROR 91.7 · χ² 3,280 / p <1e-300 | 82.8 EB05 63.4 · IC025 +4.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site discharge | 156 | 88.0 74.9–103.3ROR 88.9 · χ² 12,562 / p <1e-300 | 82.2 EB05 71.9 · IC025 +5.8 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site pain | 83 | 87.7 70.3–109.4ROR 88.2 · χ² 6,625 / p <1e-300 | 81.2 EB05 67.6 · IC025 +5.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Freezing phenomenon | 202 | 86.8 75.4–99.9ROR 88.0 · χ² 16,074 / p <1e-300 | 81.3 EB05 72.3 · IC025 +5.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Sleep attacks | 26 | 84.6 57.0–125.6ROR 84.8 · χ² 1,950 / p <1e-300 | 75.7 EB05 54.3 · IC025 +4.3 3/3 methods agree | No label text to screen | – | NCT00522379: 1/108 (0.9%) control (serious AE) |
| Product adhesion issue | 1,911 | 83.1 79.6–86.8ROR 95.7 · χ² 146,692 / p <1e-300 | 78.5 EB05 75.6 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Hyperkinesia | 85 | 61.8 49.7–76.7ROR 62.1 · χ² 4,815 / p <1e-300 | 58.5 EB05 48.8 · IC025 +5.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site infection | 50 | 58.7 44.2–77.8ROR 58.9 · χ² 2,668 / p <1e-300 | 55.3 EB05 43.6 · IC025 +4.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Impulse-control disorder | 74 | 54.3 43.1–68.5ROR 54.6 · χ² 3,682 / p <1e-300 | 51.7 EB05 42.6 · IC025 +4.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Akinesia | 74 | 54.1 42.9–68.2ROR 54.4 · χ² 3,665 / p <1e-300 | 51.5 EB05 42.4 · IC025 +4.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site irritation | 19 | 52.4 33.2–82.9ROR 52.5 · χ² 876 / p 7e-193 | 48.3 EB05 32.7 · IC025 +3.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Saliva discolouration | 11 | 50.2 27.5–91.6ROR 50.3 · χ² 466 / p 1e-103 | 45.0 EB05 26.8 · IC025 +3.0 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Rapid eye movement sleep behaviour disorder | 13 | 49.1 28.2–85.3ROR 49.1 · χ² 546 / p 4e-121 | 44.6 EB05 27.7 · IC025 +3.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Application site reaction | 221 | 46.9 41.0–53.5ROR 47.6 · χ² 9,566 / p <1e-300 | 45.3 EB05 40.5 · IC025 +5.1 3/3 methods agree | No label text to screen | – | NCT00522379: 7/94 (7.4%) on Rotigotine; 2/108 (1.9%) control |
| Orthostatic intolerance | 22 | 46.4 30.4–70.9ROR 46.5 · χ² 903 / p 1e-198 | 43.4 EB05 30.2 · IC025 +3.8 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Application site hypersensitivity | 37 | 46.1 33.3–63.9ROR 46.2 · χ² 1,539 / p <1e-300 | 43.8 EB05 33.2 · IC025 +4.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Bradykinesia | 173 | 44.6 38.3–51.8ROR 45.1 · χ² 7,107 / p <1e-300 | 43.1 EB05 37.9 · IC025 +5.0 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Parkinsonian gait | 18 | 43.4 27.2–69.4ROR 43.5 · χ² 684 / p 5e-151 | 40.5 EB05 27.1 · IC025 +3.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Stoma site haemorrhage | 40 | 39.3 28.8–53.8ROR 39.5 · χ² 1,418 / p <1e-300 | 37.7 EB05 28.9 · IC025 +4.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Sexually inappropriate behaviour | 12 | 39.0 22.0–69.3ROR 39.1 · χ² 397 / p 1e-88 | 36.1 EB05 22.0 · IC025 +3.0 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Sudden onset of sleep | 36 | 38.7 27.8–53.8ROR 38.8 · χ² 1,250 / p 4e-274 | 37.0 EB05 27.9 · IC025 +4.1 3/3 methods agree | No label text to screen | – | NCT00501969: 1/395 (0.3%) on Rotigotine (serious AE) |
| Fibroma | 24 | 38.7 25.8–58.0ROR 38.7 · χ² 821 / p 7e-181 | 36.7 EB05 25.9 · IC025 +3.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Hypersexuality | 46 | 37.5 28.0–50.2ROR 37.6 · χ² 1,557 / p <1e-300 | 36.1 EB05 28.1 · IC025 +4.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Sleep talking | 42 | 36.7 27.1–49.9ROR 36.8 · χ² 1,389 / p <1e-300 | 35.3 EB05 27.2 · IC025 +4.2 3/3 methods agree | No label text to screen | – | 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 Rotigotine 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 (4 of 40 signal terms matched).
- NCT00522379 — Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch (N=514, PHASE3; 41 AE terms posted; arms: Rotigotine 2 mg/24 hr; Rotigotine 4 mg/24 hr; Rotigotine 6 mg/24 hr; Rotigotine 8 mg/24 hr)
- NCT00501969 — An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Park (N=395, PHASE3; 182 AE terms posted; arms: Rotigotine)
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 |
|---|---|---|---|---|---|---|
| Product adhesion issue | 1,911 | 83.1 79.6–86.8ROR 95.7 · χ² 146,692 / p <1e-300 | 78.5 EB05 75.6 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,148 | 1.3 1.2–1.3ROR 1.3 · χ² 71 / p 2e-17 | 1.3 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | – | not reported in cached trials |
| Fall | 982 | 4.3 4.1–4.6ROR 4.6 · χ² 2,533 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen | – | NCT00522379: 1/104 (1.0%) on Rotigotine (serious AE) |
| Death | 945 | 1.6 1.5–1.7ROR 1.6 · χ² 221 / p 2e-50 | 1.6 EB05 1.5 · IC025 +0.6 | Outcome field, not a reaction | – | not reported in cached trials |
| Off label use (used outside approved label) | 875 | 1.5 1.4–1.6ROR 1.5 · χ² 137 / p 6e-32 | 1.5 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | – | not reported in cached trials |
| Hallucination (hallucinations) | 729 | 14.3 13.3–15.4ROR 15.0 · χ² 8,958 / p <1e-300 | 14.2 EB05 13.3 · IC025 +3.7 3/3 methods agree | No label text to screen | – | NCT00501969: 4/395 (1.0%) on Rotigotine (serious AE) |
| Dyskinesia (involuntary movements) | 668 | 24.4 22.7–26.3ROR 25.5 · χ² 14,752 / p <1e-300 | 24.0 EB05 22.5 · IC025 +4.4 3/3 methods agree | No label text to screen | – | NCT00522379: 14/94 (14.9%) on Rotigotine; 3/108 (2.8%) control |
| Tremor (shaking) | 637 | 5.6 5.2–6.0ROR 5.8 · χ² 2,416 / p <1e-300 | 5.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | – | NCT00522379: 5/94 (5.3%) on Rotigotine; 3/108 (2.8%) control |
| Nausea | 539 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.475 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | No label text to screen | – | NCT00522379: 11/94 (11.7%) on Rotigotine; 8/108 (7.4%) control |
| Dizziness | 509 | 1.5 1.4–1.6ROR 1.5 · χ² 84 / p 3e-20 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen | – | NCT00522379: 6/94 (6.4%) on Rotigotine; 9/108 (8.3%) control |
| Somnolence (drowsiness) | 470 | 3.4 3.1–3.7ROR 3.5 · χ² 806 / p 1e-177 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen | – | NCT00522379: 4/94 (4.3%) on Rotigotine; 9/108 (8.3%) control |
| Insomnia (trouble sleeping) | 456 | 2.5 2.3–2.7ROR 2.5 · χ² 412 / p 8e-92 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen | – | NCT00522379: 6/94 (6.4%) on Rotigotine; 7/108 (6.5%) control |
| Fatigue (tiredness) | 449 | 0.8 0.8–0.9ROR 0.8 · χ² 13 / p 1e-4 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | No label text to screen | – | NCT00522379: 4/94 (4.3%) on Rotigotine; 6/108 (5.6%) control |
| Application site erythema | 445 | 25.1 22.9–27.5ROR 25.8 · χ² 10,098 / p <1e-300 | 24.6 EB05 22.8 · IC025 +4.4 3/3 methods agree | No label text to screen | – | NCT00522379: 5/94 (5.3%) on Rotigotine; 2/108 (1.9%) control |
| Gait disturbance | 442 | 3.4 3.1–3.7ROR 3.4 · χ² 737 / p 1e-162 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen | – | NCT00501969: 2/395 (0.5%) on Rotigotine (serious AE) |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Rotigotine?
In FDA FAERS, the most frequently co-reported reaction terms for Rotigotine are fall, hallucination, dyskinesia, tremor, nausea, 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 Rotigotine have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Rotigotine 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,039 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
ROTIGOTINE, 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.