Drug · FAERS side-effect profile with label screen

Carbidopa and Levodopa and Entacapone side effects: what 484 FDA adverse event reports show

Carbidopa, Levodopa, And Entacapone · 16 reaction terms · 198 drug–reaction co-reports · data 2026-09-14

Drug class

Aromatic Amino Acid Decarboxylation Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Carbidopa (Carbidopa)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

484 reports · 74% serious · 88 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

FDA label, Indications and Usage

What it is

DESCRIPTION Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (–)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate.

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 11 strongest signals

Labeled adverse reaction 3Reporting / coding artifact 5Not in label — unassessed 3

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.
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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Device occlusion	12	37.4 21.4–65.4ROR 38.3 · χ² 389 / p 5e-87	35.5 EB05 21.6 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Delusion	13	36.4 21.3–62.2ROR 37.4 · χ² 413 / p 5e-92	34.7 EB05 21.6 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.4	no trial data cached
Hallucination (hallucinations)	52	30.1 23.3–38.9ROR 33.6 · χ² 1,437 / p <1e-300	29.8 EB05 23.6 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.7	no trial data cached
Dyskinesia (involuntary movements)	28	29.9 20.9–42.9ROR 31.7 · χ² 755 / p 2e-166	29.4 EB05 21.3 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.9	no trial data cached
Hallucination, visual	14	28.9 17.3–48.5ROR 29.8 · χ² 350 / p 2e-78	27.9 EB05 17.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.9	no trial data cached
Hospice care	5	22.0 9.2–52.6ROR 22.2 · χ² 80 / p 2e-19	17.8 EB05 5.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.8	no trial data cached
Hip fracture	11	14.8 8.3–26.6ROR 15.2 · χ² 129 / p 4e-30	13.4 EB05 7.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Device dislocation	13	13.0 7.6–22.2ROR 13.3 · χ² 132 / p 7e-31	11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2	no trial data cached
Device issue	21	10.4 6.9–15.8ROR 10.9 · χ² 170 / p 3e-39	9.5 EB05 6.2 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 34.7 · 71% consumer	no trial data cached
Therapeutic response shortened	5	6.8 2.8–16.3ROR 6.9 · χ² 19 / p 6e-6	4.5 EB05 2.1 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.3	no trial data cached
Device leakage	6	6.1 2.8–13.6ROR 6.2 · χ² 21 / p 2e-6	4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious n=6	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
Hallucination (hallucinations)	52	30.1 23.3–38.9ROR 33.6 · χ² 1,437 / p <1e-300	29.8 EB05 23.6 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.7	no trial data cached
Dyskinesia (involuntary movements)	28	29.9 20.9–42.9ROR 31.7 · χ² 755 / p 2e-166	29.4 EB05 21.3 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.9	no trial data cached
Device issue	21	10.4 6.9–15.8ROR 10.9 · χ² 170 / p 3e-39	9.5 EB05 6.2 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 34.7 · 71% consumer	no trial data cached
Hallucination, visual	14	28.9 17.3–48.5ROR 29.8 · χ² 350 / p 2e-78	27.9 EB05 17.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.9	no trial data cached
Device dislocation	13	13.0 7.6–22.2ROR 13.3 · χ² 132 / p 7e-31	11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2	no trial data cached
Delusion	13	36.4 21.3–62.2ROR 37.4 · χ² 413 / p 5e-92	34.7 EB05 21.6 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.4	no trial data cached
Device occlusion	12	37.4 21.4–65.4ROR 38.3 · χ² 389 / p 5e-87	35.5 EB05 21.6 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Hip fracture	11	14.8 8.3–26.6ROR 15.2 · χ² 129 / p 4e-30	13.4 EB05 7.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Device leakage	6	6.1 2.8–13.6ROR 6.2 · χ² 21 / p 2e-6	4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Therapeutic response shortened	5	6.8 2.8–16.3ROR 6.9 · χ² 19 / p 6e-6	4.5 EB05 2.1 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.3	no trial data cached
Hospice care	5	22.0 9.2–52.6ROR 22.2 · χ² 80 / p 2e-19	17.8 EB05 5.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.8	no trial data cached
Device breakage	4	4.4 1.7–11.7ROR 4.4 · χ² 7 / p 0.003	3.2 EB05 1.4 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 7.2	no trial data cached
Dystonia	4	8.9 3.4–23.6ROR 9.0 · χ² 21 / p 3e-6	5.2 EB05 2.1 · IC025 +0.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Spinal operation	4	14.3 5.4–38.0ROR 14.4 · χ² 37 / p 5e-10	8.8 EB05 2.9 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1	no trial data cached
Device difficult to use	3	2.0 0.6–6.1ROR 2.0 · χ² 1 / p 0.215	1.8 EB05 0.7 · IC025 -1.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 8.3	no trial data cached

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.

✓ 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 Carbidopa and Levodopa and Entacapone?

In FDA FAERS, the most frequently co-reported reaction terms for Carbidopa and Levodopa and Entacapone are hallucination, dyskinesia, hallucination, visual, delusion, hip fracture, hospice care. 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 Carbidopa and Levodopa and Entacapone have an FDA boxed warning?

No. The FDA label retrieved for Carbidopa and Levodopa and Entacapone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Carbidopa and Levodopa and Entacapone 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 55b99f22-9eb2-4df6-9979-bc4c3af5e454, effective 20251217; matched on openfda.generic_name.exact:"CARBIDOPA")
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, field patient.drug.openfda.generic_name.exact, 16 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.