Drug · FAERS side-effect profile with label screen
Levodopa side effects: what 12,012 FDA adverse event reports show
Brand names
Inbrija
openFDA label
Who reports
12,012 reports · 50% serious · 1,359 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa ( 1 )
FDA label, Indications and Usage
What it is
INBRIJA consists of a dry powder formulation of levodopa for oral inhalation with the INBRIJA inhaler. The inhalation powder is packaged in white hypromellose capsules.
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
Likely indication confounding 2Reporting / coding artifact 5Not in label — unassessed 33
What the badges mean
- 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.
- 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. 998 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 |
|---|---|---|---|---|---|---|
| Saliva discolouration | 92 | 676.8 532.1–860.9ROR 682.1 · χ² 44,081 / p <1e-300 | 441.3 EB05 370.7 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=6 · 87% consumer | no trial data cached |
| Dopamine dysregulation syndrome | 83 | 398.0 313.7–505.0ROR 400.8 · χ² 26,376 / p <1e-300 | 301.0 EB05 250.5 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 14% (drug 44%) · 100% clinician | no trial data cached |
| Paraphilia | 15 | 224.5 131.1–384.5ROR 224.8 · χ² 2,759 / p <1e-300 | 158.9 EB05 102.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Product residue present | 562 | 207.1 190.1–225.7ROR 217.2 · χ² 102,746 / p <1e-300 | 183.8 EB05 171.4 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=66 · 94% consumer | no trial data cached |
| Nasal mucosal discolouration | 17 | 201.8 122.2–333.5ROR 202.1 · χ² 2,864 / p <1e-300 | 150.5 EB05 99.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Patient dissatisfaction with device | 23 | 186.8 121.5–287.1ROR 187.1 · χ² 3,668 / p <1e-300 | 148.1 EB05 103.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Camptocormia | 23 | 185.9 120.9–285.7ROR 186.2 · χ² 3,652 / p <1e-300 | 147.5 EB05 103.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 · 91% clinician | no trial data cached |
| Therapeutic product effect variable | 327 | 163.6 146.3–183.0ROR 168.1 · χ² 48,119 / p <1e-300 | 148.2 EB05 135.2 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=51 · 89% consumer | no trial data cached |
| Deep brain stimulation | 45 | 146.4 108.1–198.4ROR 147.0 · χ² 5,857 / p <1e-300 | 127.8 EB05 99.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=39 · 78% consumer | no trial data cached |
| Nasal discharge discolouration | 88 | 118.7 95.7–147.2ROR 119.6 · χ² 9,501 / p <1e-300 | 108.6 EB05 90.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | 93% consumer | no trial data cached |
| Jealous delusion | 18 | 117.8 73.1–189.9ROR 118.0 · χ² 1,844 / p <1e-300 | 99.0 EB05 66.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| On and off phenomenon | 328 | 116.0 103.9–129.5ROR 119.2 · χ² 34,927 / p <1e-300 | 108.0 EB05 98.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=265 | no trial data cached |
| Parkinsonism hyperpyrexia syndrome | 11 | 112.7 61.3–207.4ROR 112.8 · χ² 1,041 / p 1e-228 | 89.8 EB05 53.5 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Mucosal discolouration | 38 | 110.3 79.5–153.1ROR 110.7 · χ² 3,766 / p <1e-300 | 98.7 EB05 75.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=6 · 84% consumer | no trial data cached |
| Vascular encephalopathy | 16 | 103.2 62.3–170.8ROR 103.3 · χ² 1,432 / p <1e-300 | 87.5 EB05 57.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Device colour issue | 22 | 101.5 66.1–156.0ROR 101.7 · χ² 1,974 / p <1e-300 | 88.8 EB05 61.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=7 · 86% consumer | no trial data cached |
| Freezing phenomenon | 197 | 101.1 87.7–116.6ROR 102.8 · χ² 18,358 / p <1e-300 | 94.7 EB05 84.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=128 | no trial data cached |
| Stoma site irritation | 29 | 97.7 67.2–142.0ROR 97.9 · χ² 2,536 / p <1e-300 | 87.3 EB05 63.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Pleurothotonus | 46 | 92.7 69.0–124.7ROR 93.1 · χ² 3,874 / p <1e-300 | 85.0 EB05 66.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 65% (drug 44%) · 100% clinician | no trial data cached |
| Progressive supranuclear palsy | 10 | 91.6 48.5–172.9ROR 91.6 · χ² 767 / p 5e-169 | 75.0 EB05 43.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Expulsion of medication | 24 | 88.3 58.6–133.0ROR 88.5 · χ² 1,888 / p <1e-300 | 78.9 EB05 55.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=9 · ♀ 68% (drug 44%) · 100% consumer | no trial data cached |
| Impulse-control disorder | 97 | 86.3 70.4–105.7ROR 86.9 · χ² 7,704 / p <1e-300 | 80.9 EB05 68.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=88 | no trial data cached |
| Dropped head syndrome | 17 | 79.7 49.1–129.6ROR 79.9 · χ² 1,189 / p 7e-261 | 70.5 EB05 46.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Fibroma | 40 | 78.5 57.2–107.7ROR 78.8 · χ² 2,854 / p <1e-300 | 72.6 EB05 55.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Reduced facial expression | 43 | 78.3 57.7–106.2ROR 78.5 · χ² 3,063 / p <1e-300 | 72.6 EB05 56.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial data cached |
| Stoma site reaction | 27 | 72.4 49.3–106.4ROR 72.6 · χ² 1,757 / p <1e-300 | 66.4 EB05 47.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 78% (drug 44%) | no trial data cached |
| Stoma site erythema | 67 | 64.8 50.8–82.7ROR 65.2 · χ² 3,997 / p <1e-300 | 61.5 EB05 50.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=65 | no trial data cached |
| Stoma site discharge | 87 | 57.2 46.2–70.8ROR 57.6 · χ² 4,595 / p <1e-300 | 54.8 EB05 45.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=84 | no trial data cached |
| Akinesia | 63 | 54.8 42.7–70.4ROR 55.1 · χ² 3,173 / p <1e-300 | 52.3 EB05 42.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=62 | no trial data cached |
| Product packaging difficult to open | 69 | 50.1 39.5–63.6ROR 50.4 · χ² 3,181 / p <1e-300 | 48.1 EB05 39.3 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=5 · 90% consumer | no trial data cached |
| Intentional underdose | 202 | 49.7 43.3–57.2ROR 50.6 · χ² 9,334 / p <1e-300 | 48.2 EB05 42.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=21 · 95% consumer | no trial data cached |
| Device use issue | 456 | 47.2 43.1–51.7ROR 49.0 · χ² 20,045 / p <1e-300 | 45.9 EB05 42.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=43 · 93% consumer | no trial data cached |
| Stoma site extravasation | 10 | 45.8 24.4–85.8ROR 45.8 · χ² 384 / p 8e-86 | 41.4 EB05 24.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hypersexuality | 46 | 44.9 33.5–60.1ROR 45.0 · χ² 1,880 / p <1e-300 | 43.0 EB05 33.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 7% (drug 44%) | no trial data cached |
| Rapid eye movement sleep behaviour disorder | 10 | 44.8 23.9–84.0ROR 44.9 · χ² 376 / p 5e-84 | 40.6 EB05 23.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Hyperkinesia | 52 | 44.5 33.8–58.6ROR 44.7 · χ² 2,113 / p <1e-300 | 42.8 EB05 33.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=51 | no trial data cached |
| Bradykinesia | 143 | 43.9 37.2–51.7ROR 44.4 · χ² 5,801 / p <1e-300 | 42.6 EB05 37.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=127 | no trial data cached |
| Pathological gambling | 41 | 43.6 32.0–59.4ROR 43.7 · χ² 1,622 / p <1e-300 | 41.8 EB05 32.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 8% (drug 44%) | no trial data cached |
| Parkinsonian gait | 15 | 43.1 25.8–71.9ROR 43.2 · χ² 562 / p 2e-124 | 40.1 EB05 25.8 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Sputum discoloured | 225 | 42.5 37.3–48.5ROR 43.3 · χ² 8,872 / p <1e-300 | 41.4 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 87% 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 |
|---|---|---|---|---|---|---|
| Cough | 2,270 | 14.3 13.7–14.8ROR 17.4 · χ² 28,146 / p <1e-300 | 14.2 EB05 13.7 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 93% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 1,422 | 1.9 1.8–2.0ROR 2.0 · χ² 630 / p 2e-139 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 · 76% consumer | no trial data cached |
| Dyskinesia (involuntary movements) | 760 | 33.3 31.1–35.7ROR 35.5 · χ² 23,387 / p <1e-300 | 32.7 EB05 30.8 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.1 | no trial data cached |
| Death | 716 | 1.5 1.4–1.6ROR 1.5 · χ² 104 / p 9e-25 | 1.5 EB05 1.4 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 1.7 · 71% consumer | no trial data cached |
| Fall | 705 | 3.7 3.5–4.0ROR 3.9 · χ² 1,411 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Device issue | 694 | 14.0 13.0–15.0ROR 14.8 · χ² 8,323 / p <1e-300 | 13.9 EB05 13.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 · 90% consumer | no trial data cached |
| Condition aggravated | 687 | 4.0 3.7–4.3ROR 4.2 · χ² 1,547 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 72% consumer | no trial data cached |
| Hallucination (hallucinations) | 656 | 15.4 14.3–16.6ROR 16.2 · χ² 8,774 / p <1e-300 | 15.3 EB05 14.3 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 | no trial data cached |
| Product residue present | 562 | 207.1 190.1–225.7ROR 217.2 · χ² 102,746 / p <1e-300 | 183.8 EB05 171.4 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=66 · 94% consumer | no trial data cached |
| Tremor (shaking) | 533 | 5.6 5.2–6.1ROR 5.8 · χ² 2,025 / p <1e-300 | 5.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Device difficult to use | 509 | 13.5 12.4–14.7ROR 14.1 · χ² 5,873 / p <1e-300 | 13.4 EB05 12.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 21.6 · 92% consumer | no trial data cached |
| Device use issue | 456 | 47.2 43.1–51.7ROR 49.0 · χ² 20,045 / p <1e-300 | 45.9 EB05 42.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=43 · 93% consumer | no trial data cached |
| Dizziness | 455 | 1.6 1.5–1.7ROR 1.6 · χ² 103 / p 2e-24 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Fatigue (tiredness) | 452 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.377 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Nausea | 417 | 0.9 0.8–1.0ROR 0.9 · χ² 3 / p 0.049 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 · ♀ 64% (drug 44%) | 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.
- Saliva discolouration — n=92, PRR 676.8
- Dopamine dysregulation syndrome — n=83, PRR 398.0
- Patient dissatisfaction with device — n=23, PRR 186.8
- Camptocormia — n=23, PRR 185.9
- Deep brain stimulation — n=45, PRR 146.4
- Nasal discharge discolouration — n=88, PRR 118.7
- On and off phenomenon — n=328, PRR 116.0
- Mucosal discolouration — n=38, PRR 110.3
- Freezing phenomenon — n=197, PRR 101.1
- Stoma site irritation — n=29, PRR 97.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Levodopa ↔ Dyskinesia.
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 Levodopa?
In FDA FAERS, the most frequently co-reported reaction terms for Levodopa are cough, dyskinesia, fall, hallucination, tremor, 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 Levodopa have an FDA boxed warning?
No. The FDA label retrieved for Levodopa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Levodopa 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 077c0f39-a3a2-4b2b-a184-09131889dcfb, effective 20260720; matched on
openfda.generic_name.exact:"LEVODOPA") - 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, 1,038 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.