Drug · FAERS side-effect profile with label screen
Foscarbidopa and Foslevodopa side effects: what 7,378 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Foscarbidopa/Foslevodopa (Vyalev)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
7,378 reports · 84% serious · 1,155 with death outcome · 41% female
openFDA FAERS counts, all years, deduplication not applied
Used for
VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a combination of foscarbidopa (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. ( 1 )
FDA label, Indications and Usage
What it is
VYALEV injection is a solution that is a combination of foscarbidopa (carbidopa-4´-monophosphate) and foslevodopa (levodopa-4´-monophosphate). Foscarbidopa and foslevodopa are prodrugs that undergo enzymatic bioconversion via intrinsic alkaline phosphatase to carbidopa and levodopa, respectively, in vivo .
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 8Labeled (related wording) 3Reporting / coding artifact 6Not 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.
- 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.
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. 247 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 |
|---|---|---|---|---|---|---|
| Infusion site pain | 281 | 63.9 56.9–71.8ROR 66.4 · χ² 16,969 / p <1e-300 | 62.3 EB05 56.4 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=187 · 71% consumer | no trial data cached |
| Hypokinesia | 247 | 49.1 43.4–55.6ROR 50.8 · χ² 11,408 / p <1e-300 | 48.1 EB05 43.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 41.8 · 83% consumer | no trial data cached |
| Dyskinesia (involuntary movements) | 585 | 41.6 38.4–45.0ROR 45.1 · χ² 22,836 / p <1e-300 | 40.9 EB05 38.2 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.0 | no trial data cached |
| Muscle rigidity | 145 | 34.9 29.7–41.0ROR 35.6 · χ² 4,685 / p <1e-300 | 34.3 EB05 29.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 | no trial data cached |
| Hallucination (hallucinations) | 741 | 28.4 26.5–30.4ROR 31.4 · χ² 19,412 / p <1e-300 | 28.1 EB05 26.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.2 | no trial data cached |
| Hallucination, visual | 180 | 24.6 21.3–28.4ROR 25.2 · χ² 4,018 / p <1e-300 | 24.3 EB05 21.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 | no trial data cached |
| Delusion | 108 | 20.0 16.5–24.1ROR 20.2 · χ² 1,913 / p <1e-300 | 19.8 EB05 16.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 | no trial data cached |
| Movement disorder | 186 | 16.5 14.3–19.0ROR 16.9 · χ² 2,676 / p <1e-300 | 16.4 EB05 14.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 84% consumer | no trial data cached |
| Motor dysfunction | 56 | 15.8 12.2–20.5ROR 15.9 · χ² 758 / p 3e-167 | 15.6 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Skin infection | 61 | 15.6 12.2–20.1ROR 15.7 · χ² 816 / p 1e-179 | 15.4 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Mobility decreased | 368 | 14.7 13.3–16.2ROR 15.4 · χ² 4,667 / p <1e-300 | 14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · 77% consumer | no trial data cached |
| Gait inability | 148 | 12.8 10.9–15.0ROR 13.0 · χ² 1,588 / p <1e-300 | 12.6 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 80% consumer | no trial data cached |
| Psychotic disorder | 129 | 12.5 10.5–14.8ROR 12.7 · χ² 1,344 / p 1e-294 | 12.3 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 | no trial data cached |
| Device issue | 375 | 12.3 11.1–13.5ROR 12.9 · χ² 3,867 / p <1e-300 | 12.2 EB05 11.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 31.2 · 82% consumer | no trial data cached |
| Device occlusion | 57 | 11.7 9.0–15.1ROR 11.8 · χ² 545 / p 9e-121 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=50 · 81% consumer | no trial data cached |
| Therapeutic product effect incomplete | 287 | 11.6 10.3–13.0ROR 12.0 · χ² 2,761 / p <1e-300 | 11.5 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · 74% consumer | no trial data cached |
| Dystonia | 75 | 11.0 8.8–13.8ROR 11.1 · χ² 669 / p 8e-148 | 10.7 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 73% consumer | no trial data cached |
| Nodule | 50 | 10.9 8.3–14.4ROR 11.0 · χ² 440 / p 7e-98 | 10.5 EB05 8.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Paranoia | 66 | 10.9 8.5–13.8ROR 11.0 · χ² 580 / p 2e-128 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · 71% consumer | no trial data cached |
| Unresponsive to stimuli | 98 | 10.9 8.9–13.2ROR 11.0 · χ² 866 / p 1e-190 | 10.7 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 79% consumer | no trial data cached |
| Poor quality sleep | 77 | 10.3 8.2–12.8ROR 10.4 · χ² 633 / p 7e-140 | 10.0 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 77% consumer | no trial data cached |
| General physical health deterioration | 371 | 9.2 8.3–10.2ROR 9.6 · χ² 2,711 / p <1e-300 | 9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Cognitive disorder | 150 | 9.2 7.8–10.8ROR 9.4 · χ² 1,086 / p 2e-238 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Hip fracture | 101 | 9.0 7.4–10.9ROR 9.1 · χ² 706 / p 8e-156 | 8.7 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 77% consumer | no trial data cached |
| Musculoskeletal disorder | 60 | 8.9 6.9–11.5ROR 9.0 · χ² 414 / p 3e-92 | 8.6 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · 77% consumer | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 54 | 8.8 6.8–11.5ROR 8.9 · χ² 366 / p 8e-82 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Knee operation | 30 | 8.8 6.2–12.6ROR 8.8 · χ² 199 / p 2e-45 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 97% consumer | no trial data cached |
| Aspiration | 33 | 8.7 6.2–12.2ROR 8.7 · χ² 216 / p 3e-49 | 8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Aggression | 151 | 8.6 7.3–10.0ROR 8.7 · χ² 1,003 / p 2e-220 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Delirium | 104 | 8.6 7.1–10.4ROR 8.7 · χ² 687 / p 1e-151 | 8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Pneumonia aspiration | 73 | 8.3 6.6–10.5ROR 8.4 · χ² 464 / p 3e-103 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Loss of personal independence in daily activities | 135 | 8.1 6.8–9.6ROR 8.2 · χ² 831 / p 5e-183 | 7.9 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 70% consumer | no trial data cached |
| Restlessness | 104 | 8.1 6.7–9.8ROR 8.2 · χ² 638 / p 5e-141 | 7.9 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Speech disorder | 146 | 7.9 6.8–9.3ROR 8.1 · χ² 878 / p 3e-193 | 7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 75% consumer | no trial data cached |
| Hallucination, auditory | 44 | 7.9 5.9–10.6ROR 7.9 · χ² 257 / p 4e-58 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 77% consumer | no trial data cached |
| Abscess | 44 | 7.9 5.9–10.6ROR 7.9 · χ² 256 / p 6e-58 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Unintentional medical device removal | 32 | 7.8 5.5–11.0ROR 7.8 · χ² 183 / p 7e-42 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=31 · 84% consumer | no trial data cached |
| Fall | 906 | 7.8 7.3–8.3ROR 8.7 · χ² 5,403 / p <1e-300 | 7.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 75% consumer | no trial data cached |
| Hypophagia | 69 | 7.7 6.1–9.8ROR 7.8 · χ² 398 / p 7e-89 | 7.4 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 61% (drug 41%) · 77% consumer | no trial data cached |
| Musculoskeletal stiffness | 225 | 7.3 6.4–8.3ROR 7.5 · χ² 1,221 / p 7e-268 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 81% consumer | 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 |
|---|---|---|---|---|---|---|
| Fall | 906 | 7.8 7.3–8.3ROR 8.7 · χ² 5,403 / p <1e-300 | 7.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 75% consumer | no trial data cached |
| Hallucination (hallucinations) | 741 | 28.4 26.5–30.4ROR 31.4 · χ² 19,412 / p <1e-300 | 28.1 EB05 26.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.2 | no trial data cached |
| Death | 587 | 1.9 1.8–2.1ROR 2.0 · χ² 277 / p 2e-62 | 1.9 EB05 1.8 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 1.3 | no trial data cached |
| Dyskinesia (involuntary movements) | 585 | 41.6 38.4–45.0ROR 45.1 · χ² 22,836 / p <1e-300 | 40.9 EB05 38.2 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.0 | no trial data cached |
| Tremor (shaking) | 403 | 6.9 6.3–7.6ROR 7.2 · χ² 2,040 / p <1e-300 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 79% consumer | no trial data cached |
| Device issue | 375 | 12.3 11.1–13.5ROR 12.9 · χ² 3,867 / p <1e-300 | 12.2 EB05 11.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 31.2 · 82% consumer | no trial data cached |
| General physical health deterioration | 371 | 9.2 8.3–10.2ROR 9.6 · χ² 2,711 / p <1e-300 | 9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Mobility decreased | 368 | 14.7 13.3–16.2ROR 15.4 · χ² 4,667 / p <1e-300 | 14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · 77% consumer | no trial data cached |
| Malaise (feeling unwell) | 335 | 2.2 2.0–2.4ROR 2.2 · χ² 214 / p 1e-48 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.3 · 80% consumer | no trial data cached |
| Confusional state (confusion) | 314 | 5.5 5.0–6.2ROR 5.7 · χ² 1,165 / p 1e-255 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Asthenia (weakness) | 309 | 2.3 2.1–2.6ROR 2.4 · χ² 239 / p 3e-54 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 · 81% consumer | no trial data cached |
| Urinary tract infection (bladder infection) | 294 | 4.9 4.4–5.5ROR 5.1 · χ² 920 / p 2e-202 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 74% consumer | no trial data cached |
| Pneumonia (lung infection) | 288 | 2.5 2.3–2.8ROR 2.6 · χ² 270 / p 6e-61 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 · 71% consumer | no trial data cached |
| Therapeutic product effect incomplete | 287 | 11.6 10.3–13.0ROR 12.0 · χ² 2,761 / p <1e-300 | 11.5 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · 74% consumer | no trial data cached |
| Infusion site pain | 281 | 63.9 56.9–71.8ROR 66.4 · χ² 16,969 / p <1e-300 | 62.3 EB05 56.4 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=187 · 71% consumer | 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.
- Hypokinesia — n=247, PRR 49.1
- Muscle rigidity — n=145, PRR 34.9
- Hallucination, visual — n=180, PRR 24.6
- Movement disorder — n=186, PRR 16.5
- Motor dysfunction — n=56, PRR 15.8
- Mobility decreased — n=368, PRR 14.7
- Gait inability — n=148, PRR 12.8
- Dystonia — n=75, PRR 11.0
- Unresponsive to stimuli — n=98, PRR 10.9
- Cognitive disorder — n=150, PRR 9.2
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 Foscarbidopa and Foslevodopa?
In FDA FAERS, the most frequently co-reported reaction terms for Foscarbidopa and Foslevodopa are fall, hallucination, dyskinesia, tremor, mobility decreased, malaise. 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 Foscarbidopa and Foslevodopa have an FDA boxed warning?
No. The FDA label retrieved for Foscarbidopa and Foslevodopa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Foscarbidopa and Foslevodopa 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 28e806e4-951c-40a9-9f0c-d0929caf054c, effective 20260319; matched on
openfda.generic_name.exact:"FOSCARBIDOPA/FOSLEVODOPA") - 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, 287 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.