Generic name
Apomorphine hydrochloride: adverse event reports filed with FDA
750 reports list it as a suspect or interacting product, 2005–2026. Class: Dopaminergic agonist.
- 750
- reports as suspect product
- 0% of all reports · about 35 a year
- 46
- reports, 12 months to June 2026
- 63 in the 12 months before
- 98.7%
- marked serious by the reporter
- 33.2% across the class
- 8.3%
- record death among outcomes, as reported
- 62 reports · not verified by FDA
750 adverse event reports received by FDA list apomorphine hydrochloride, a generic name as a suspect or interacting product, from April 2005 to June 2026. A further 81 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 46 reports listed it, down 27% from 63 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 35 reports a year and 0% of the 20,646,523 reports in the database, and 11.4% of the reports for the dopaminergic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are hypotension (11.5%), cerebral hypoperfusion (8.8%) and speech disorder (8.4%). A report can list several reactions, so shares add to more than 100%; 278 different terms appear across these reports. Hypotension is recorded in 11.5% of these reports, a larger share than in the median dopaminergic agonist drug (5.2%).
98.7% of the reports are marked serious by the reporter (33.2% across the class); 8.3% record death among the outcomes and 47.1% record hospitalisation, as reported. 44.8% of the reports came from other health professionals, and the largest patient age group is 65 to 74 (24%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Apomorphine hydrochloride reports recording the termmedian drug in dopaminergic agonist
- Hypotensionlow blood pressure11.5%86
- Cerebral hypoperfusion8.8%66
- Speech disordera speech problem8.4%63
- Gait disturbancedifficulty walking8.3%62
- Constipationconstipation8.1%61
- Feeling coldfeeling cold7.3%55
- Injection site nodule6.8%51
- Falla fall5.9%44
- Dizzinesslight-headedness or unsteadiness5.1%38
- Injection site necrosisdeath of tissue where the injection was given5.1%38
- Balance disorderproblems with balance4.9%37
- Haemolytic anaemia4.5%34
- Depressionlow mood4.3%32
- Somnolencedrowsiness4.3%32
- Dysarthria4.1%31
- Presyncope3.9%29
- Abdominal distensiona bloated abdomen3.7%28
- Dyskinesiainvoluntary movements3.7%28
- Hallucinationseeing or hearing things that are not there3.6%27
- Nauseafeeling sick3.6%27
- Binocular eye movement disorder3.5%26
- Cerebellar stroke3.5%26
- Diplopiadouble vision3.5%26
- Dysphoniaa hoarse voice3.5%26
- Micturition urgency3.5%26
- Neuralgia3.5%26
- Neuropathy peripheralnerve damage in hands or feet3.5%26
- Nocturia3.5%26
- On and off phenomenon3.2%24
Top 30 of 278 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the dopaminergic agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 6,603 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 5.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Parkinson's disease | 382 | 50.9% |
| Parkinson's disease | 28 | 3.7% |
| On and off phenomenon | 8 | 1.1% |
| Pain | 5 | 0.7% |
| Parkinsonism | 4 | 0.5% |
| Erectile dysfunction | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 750 reports.
In context
| Measure | Apomorphine hydrochloride | Dopaminergic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 750 | 6,603 | 20,646,523 |
| Share of that pool | — | 11.4% | 0% |
| Reports, latest 12 months | 46 | — | 1,332,454 |
| Marked serious | 98.7% | 33.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 83 | 58 | 91 |
| Hospitalisation recorded, per 1,000 reports | 471 | 163 | 213 |
| Consumer-filed share | 27.5% | 67.9% | 45.8% |
| Top term, share of reports | Hypotension 11.5% | median 5.2% | 1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the dopaminergic agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Apokyn | brand | 5,274 | 188 | 24.1% |
| Onapgo | brand | 579 | 568 | 32% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Apomorphine hydrochloride reports
How many adverse event reports has FDA received for Apomorphine hydrochloride?
750 reports list Apomorphine hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 46 of them arrived in the latest 12 months. Another 81 list it only as a concomitant medication.
What reactions are recorded in Apomorphine hydrochloride reports?
hypotension (11.5%), cerebral hypoperfusion (8.8%), speech disorder (8.4%), gait disturbance (8.3%) and constipation (8.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Apomorphine hydrochloride was responsible.
How serious are the reports?
98.7% are marked serious by the reporter. Among the outcomes recorded, 8.3% of reports include death and 47.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (44.8%), consumer or non-health professional (27.5%) and physician (17.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Apomorphine hydrochloride rising?
46 reports in the 12 months to June 2026, down 27% from 63 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Apomorphine hydrochloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Apomorphine hydrochloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Apomorphine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (81) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.