Drug · FAERS side-effect profile with label screen
Apomorphine side effects: what 804 FDA adverse event reports show
Drug class
Non-ergoline dopamine agonist
FDA label, Indications wording of the closest related product
Label matched
Apomorphine Hydrochloride (Apomorphine Hydrocloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
804 reports · 98% serious · 78 with death outcome · 38% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications .
FDA label, Indications and Usage
What it is
apomorphine hydrocloride (apomorphine hydrochloride injection) contains apomorphine hydrochloride, a non-ergoline dopamine agonist. Apomorphine hydrochloride is chemically designated as 6aβ-Aporphine-10,11-diol hydrochloride hemihydrate with a molecular formula of C 17 H 17 NO 2 ∙ HCl ∙ ½ H 2 O.
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 7Labeled (related wording) 9Reporting / coding artifact 5Not in label — unassessed 19
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. 37 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 |
|---|---|---|---|---|---|---|
| Injection site nodule | 89 | 122.9 100.4–150.4ROR 131.2 · χ² 10,554 / p <1e-300 | 118.8 EB05 99.5 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=53 | no trial data cached |
| Injection site irritation | 59 | 70.5 54.9–90.5ROR 73.5 · χ² 3,955 / p <1e-300 | 68.6 EB05 55.2 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Dyskinesia (involuntary movements) | 164 | 61.1 52.9–70.5ROR 69.1 · χ² 9,609 / p <1e-300 | 60.4 EB05 53.0 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.7 | no trial data cached |
| Nodule | 37 | 42.8 31.1–58.8ROR 43.9 · χ² 1,464 / p <1e-300 | 41.8 EB05 31.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 34.6 | no trial data cached |
| Micturition urgency | 30 | 39.9 28.0–56.9ROR 40.8 · χ² 1,097 / p 8e-241 | 38.9 EB05 28.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 64.9 · ♀ 0% (drug 38%) | no trial data cached |
| Nocturia (night-time urination) | 29 | 36.1 25.2–51.8ROR 36.8 · χ² 953 / p 1e-209 | 35.3 EB05 25.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 63.2 · ♀ 0% (drug 38%) | no trial data cached |
| Feeling cold | 55 | 29.7 22.9–38.5ROR 30.9 · χ² 1,497 / p <1e-300 | 29.4 EB05 23.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.9 · ♀ 0% (drug 38%) | no trial data cached |
| Device occlusion | 27 | 29.3 20.1–42.5ROR 29.8 · χ² 708 / p 3e-156 | 28.7 EB05 20.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Hallucination (hallucinations) | 120 | 24.1 20.3–28.6ROR 26.3 · χ² 2,641 / p <1e-300 | 24.0 EB05 20.6 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.2 · ♀ 17% (drug 38%) | no trial data cached |
| Speech disorder | 83 | 23.9 19.4–29.4ROR 25.3 · χ² 1,797 / p <1e-300 | 23.7 EB05 19.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.3 · ♀ 7% (drug 38%) | no trial data cached |
| Presyncope (near-fainting) | 35 | 21.8 15.7–30.2ROR 22.3 · χ² 673 / p 1e-148 | 21.5 EB05 16.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · ♀ 0% (drug 38%) | no trial data cached |
| Hallucination, visual | 30 | 21.5 15.1–30.7ROR 22.0 · χ² 567 / p 1e-125 | 21.2 EB05 15.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Neuralgia | 30 | 18.6 13.1–26.5ROR 19.0 · χ² 483 / p 2e-107 | 18.4 EB05 13.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.2 · ♀ 0% (drug 38%) | no trial data cached |
| Salivary hypersecretion | 12 | 18.1 10.3–31.8ROR 18.2 · χ² 177 / p 1e-40 | 17.1 EB05 9.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.9 | no trial data cached |
| Diplopia (double vision) | 30 | 17.4 12.2–24.8ROR 17.8 · χ² 447 / p 1e-99 | 17.1 EB05 12.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · ♀ 3% (drug 38%) | no trial data cached |
| Device defective | 18 | 16.7 10.6–26.5ROR 17.0 · χ² 251 / p 8e-57 | 16.2 EB05 10.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Dystonia | 21 | 16.2 10.6–24.8ROR 16.5 · χ² 285 / p 3e-64 | 15.8 EB05 10.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Dysarthria (slurred speech) | 39 | 15.6 11.5–21.3ROR 16.0 · χ² 519 / p 3e-115 | 15.4 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 15% (drug 38%) | no trial data cached |
| Infusion site pain | 13 | 15.3 8.9–26.3ROR 15.5 · χ² 160 / p 6e-37 | 14.2 EB05 8.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Muscle rigidity | 12 | 15.1 8.6–26.6ROR 15.2 · χ² 144 / p 2e-33 | 13.9 EB05 7.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Somnolence (drowsiness) | 195 | 14.6 12.8–16.6ROR 16.8 · χ² 2,479 / p <1e-300 | 14.6 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Brain fog | 13 | 13.4 7.8–23.0ROR 13.5 · χ² 137 / p 6e-32 | 12.1 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Injection site induration | 11 | 12.8 7.1–23.0ROR 12.9 · χ² 108 / p 1e-25 | 11.0 EB05 5.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 14 | 12.1 7.2–20.3ROR 12.2 · χ² 131 / p 1e-30 | 10.7 EB05 6.2 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Injection site erythema (redness where injected) | 98 | 12.0 9.9–14.5ROR 12.8 · χ² 977 / p 7e-215 | 11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 | no trial data cached |
| Movement disorder | 22 | 10.3 6.8–15.5ROR 10.4 · χ² 175 / p 3e-40 | 9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Balance disorder | 58 | 10.1 7.8–13.0ROR 10.5 · χ² 467 / p 7e-104 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.1 · ♀ 5% (drug 38%) | no trial data cached |
| Incorrect route of product administration | 11 | 9.9 5.5–17.8ROR 9.9 · χ² 79 / p 3e-19 | 8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 | no trial data cached |
| Pallor | 17 | 9.4 5.8–15.0ROR 9.5 · χ² 119 / p 5e-28 | 8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Psychotic disorder | 18 | 9.2 5.8–14.5ROR 9.3 · χ² 123 / p 7e-29 | 8.0 EB05 5.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Injection site swelling | 46 | 9.1 6.9–12.1ROR 9.4 · χ² 326 / p 3e-73 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Hypotension (low blood pressure) | 118 | 8.9 7.5–10.5ROR 9.6 · χ² 823 / p 3e-181 | 8.7 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · ♀ 8% (drug 38%) | no trial data cached |
| Device issue | 46 | 7.9 6.0–10.5ROR 8.2 · χ² 273 / p 1e-61 | 7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Dysphonia | 29 | 7.5 5.2–10.7ROR 7.6 · χ² 156 / p 3e-36 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 4% (drug 38%) | no trial data cached |
| Gait disturbance | 95 | 7.4 6.1–9.0ROR 7.9 · χ² 529 / p 3e-117 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 3% (drug 38%) | no trial data cached |
| Device breakage | 19 | 7.3 4.7–11.4ROR 7.4 · χ² 97 / p 4e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Injection site pruritus | 32 | 7.2 5.1–10.2ROR 7.4 · χ² 166 / p 2e-38 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Unresponsive to stimuli | 12 | 7.0 4.0–12.3ROR 7.1 · χ² 56 / p 3e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Fall | 151 | 6.8 5.9–7.9ROR 7.5 · χ² 758 / p 4e-167 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Injection site mass | 16 | 6.5 4.0–10.6ROR 6.6 · χ² 70 / p 4e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.9 | 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 |
|---|---|---|---|---|---|---|
| Somnolence (drowsiness) | 195 | 14.6 12.8–16.6ROR 16.8 · χ² 2,479 / p <1e-300 | 14.6 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Dyskinesia (involuntary movements) | 164 | 61.1 52.9–70.5ROR 69.1 · χ² 9,609 / p <1e-300 | 60.4 EB05 53.0 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.7 | no trial data cached |
| Fall | 151 | 6.8 5.9–7.9ROR 7.5 · χ² 758 / p 4e-167 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Hallucination (hallucinations) | 120 | 24.1 20.3–28.6ROR 26.3 · χ² 2,641 / p <1e-300 | 24.0 EB05 20.6 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.2 · ♀ 17% (drug 38%) | no trial data cached |
| Hypotension (low blood pressure) | 118 | 8.9 7.5–10.5ROR 9.6 · χ² 823 / p 3e-181 | 8.7 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · ♀ 8% (drug 38%) | no trial data cached |
| Injection site erythema (redness where injected) | 98 | 12.0 9.9–14.5ROR 12.8 · χ² 977 / p 7e-215 | 11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 | no trial data cached |
| Gait disturbance | 95 | 7.4 6.1–9.0ROR 7.9 · χ² 529 / p 3e-117 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 3% (drug 38%) | no trial data cached |
| Injection site nodule | 89 | 122.9 100.4–150.4ROR 131.2 · χ² 10,554 / p <1e-300 | 118.8 EB05 99.5 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=53 | no trial data cached |
| Speech disorder | 83 | 23.9 19.4–29.4ROR 25.3 · χ² 1,797 / p <1e-300 | 23.7 EB05 19.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.3 · ♀ 7% (drug 38%) | no trial data cached |
| Injection site irritation | 59 | 70.5 54.9–90.5ROR 73.5 · χ² 3,955 / p <1e-300 | 68.6 EB05 55.2 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Balance disorder | 58 | 10.1 7.8–13.0ROR 10.5 · χ² 467 / p 7e-104 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.1 · ♀ 5% (drug 38%) | no trial data cached |
| Feeling cold | 55 | 29.7 22.9–38.5ROR 30.9 · χ² 1,497 / p <1e-300 | 29.4 EB05 23.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.9 · ♀ 0% (drug 38%) | no trial data cached |
| Device issue | 46 | 7.9 6.0–10.5ROR 8.2 · χ² 273 / p 1e-61 | 7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Injection site swelling | 46 | 9.1 6.9–12.1ROR 9.4 · χ² 326 / p 3e-73 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Dysarthria (slurred speech) | 39 | 15.6 11.5–21.3ROR 16.0 · χ² 519 / p 3e-115 | 15.4 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 15% (drug 38%) | 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.
- Nodule — n=37, PRR 42.8
- Micturition urgency — n=30, PRR 39.9
- Nocturia — n=29, PRR 36.1
- Feeling cold — n=55, PRR 29.7
- Speech disorder — n=83, PRR 23.9
- Presyncope — n=35, PRR 21.8
- Hallucination, visual — n=30, PRR 21.5
- Neuralgia — n=30, PRR 18.6
- Diplopia — n=30, PRR 17.4
- Dystonia — n=21, PRR 16.2
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 Apomorphine?
In FDA FAERS, the most frequently co-reported reaction terms for Apomorphine are somnolence, dyskinesia, fall, hallucination, hypotension, injection site erythema. 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 Apomorphine have an FDA boxed warning?
No. The FDA label retrieved for Apomorphine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Apomorphine 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 aedf70e4-1949-44bc-bf1b-0f282c4f0705, effective 20220224; matched on
openfda.generic_name.exact:"APOMORPHINE HYDROCHLORIDE") - 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, 77 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.