Prescription medicine
Apomorphine Brand names: Onapgo, Apokyn
Apomorphine (Onapgo) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the apomorphine FDA label on DailyMed (effective February 24, 2022, TruPharma, LLC); the NDA 21264 record on Drugs@FDA; every apomorphine label on DailyMed.
Highlights of the record
FDA label of February 24, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageApomorphine 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.
Forms and strengths
- 4.9 mg/ml
- 30 mg/3ml
Injection; injection (solution).
On the market
- Earliest approval on file
- April 20, 2004 Apokyn, Mdd Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first February 23, 2022; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 19, 2036 Kynmobi film; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2016 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 804 through July 30, 2026
What is apomorphine used for?
From the label: indications and usageApomorphine 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 [see Clinical Studies (14) ]. Apomorphine hydrocloride injection is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease
Conditions named in the indications of apomorphine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Dopaminergic Agonist.
Source: FDA drug label (apomorphine hydrocloride), ANDA212025 (Tp Anda Holdings), as published by TruPharma, LLC, effective February 24, 2022 (SPL set aedf70e4-1949-44bc-bf1b-0f282c4f0705), via openFDA; the full label on DailyMed
What does the patient leaflet for apomorphine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using apomorphine hydrocloride injection?Do not drink alcohol while you are using apomorphine hydrocloride injection. It can increase your chance of developing serious side effects. Do not take medicines that make you sleepy while you are using apomorphine hydrocloride injection. Do not drive, operate machinery, or do other dangerous activities until you know how apomorphine hydrocloride injection affects you. Do not change your body position too fast. Get up slowly from sitting or lying. apomorphine hydrocloride injection can lower your blood pressure and cause dizziness or fainting.
From the patient leaflet: How should I store apomorphine hydrocloride injection?Store apomorphine hydrocloride injection at room temperature, 68°F to 77°F (20°C to 25°C). Safely throw away medicine that is out of date or no longer needed. Keep apomorphine hydrocloride injection and all medicines out of the reach of children.
Source: FDA drug label (apomorphine hydrocloride), ANDA212025 (Tp Anda Holdings), as published by TruPharma, LLC, effective February 24, 2022 (SPL set aedf70e4-1949-44bc-bf1b-0f282c4f0705), via openFDA; the full label on DailyMed
Is there a generic for apomorphine (Onapgo)?
The FDA approved the first generic apomorphine on February 23, 2022. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists apomorphine from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Onapgo injection; a patent listed only for Kynmobi film runs to April 19, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2022 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has apomorphine been recalled?
The FDA's Enforcement Report lists 2 recalls naming apomorphine since 2016: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of apomorphine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| July 26, 2016 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the apomorphine label say about other medicines?
The apomorphine label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name apomorphine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alosetron | contraindications | CONTRAINDICATIONS Apomorphine hydrocloride is contraindicated in patients: Using concomitant drugs of the 5HT 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1) ]. |
| Chlorpromazine | warnings and precautions | Antiemetics with anti-dopaminergic actions (e.g., haloperidol, chlorpromazine, promethazine, prochlorperazine, metaclopramide) have the potential to worsen the symptoms in patients with Parkinson's disease and should be avoided. |
| Granisetron | contraindications | CONTRAINDICATIONS Apomorphine hydrocloride is contraindicated in patients: Using concomitant drugs of the 5HT 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1) ]. |
| Haloperidol | warnings and precautions | Antiemetics with anti-dopaminergic actions (e.g., haloperidol, chlorpromazine, promethazine, prochlorperazine, metaclopramide) have the potential to worsen the symptoms in patients with Parkinson's disease and should be avoided. |
| Metoclopramide | drug interactions | DRUG INTERACTIONS Concomitant use of antihypertensive medications and vasodilators: increased risk for hypotension, myocardial infarction, pneumonia, falls, and injuries ( 7.2 ) Dopamine antagonists such as neuroleptics or metoclopramide, may diminish the effectiveness of apomorphine hydrocloride ( 7.4 ) 7.1 5HT 3 … |
| Nitroglycerin | drug interactions | Concomitant administration of 0.4 mg sublingual nitroglycerin with apomorphine hydrocloride in healthy subjects causes greater decreases in blood pressure compared to apomorphine hydrocloride alone. |
| Ondansetron | contraindications | CONTRAINDICATIONS Apomorphine hydrocloride is contraindicated in patients: Using concomitant drugs of the 5HT 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1) ]. |
| Palonosetron | contraindications | CONTRAINDICATIONS Apomorphine hydrocloride is contraindicated in patients: Using concomitant drugs of the 5HT 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1) ]. |
| Prochlorperazine | warnings and precautions | Antiemetics with anti-dopaminergic actions (e.g., haloperidol, chlorpromazine, promethazine, prochlorperazine, metaclopramide) have the potential to worsen the symptoms in patients with Parkinson's disease and should be avoided. |
| Promethazine | warnings and precautions | Antiemetics with anti-dopaminergic actions (e.g., haloperidol, chlorpromazine, promethazine, prochlorperazine, metaclopramide) have the potential to worsen the symptoms in patients with Parkinson's disease and should be avoided. |
| Trimethobenzamide | warnings and precautions | The effect of trimethobenzamide on reducing nausea and vomiting during treatment with apomorphine hydrocloride was evaluated in a 12-week, placebo-controlled study in 194 patients. |
Other labels that name apomorphine
Source: FDA drug label (apomorphine hydrocloride), ANDA212025 (Tp Anda Holdings), as published by TruPharma, LLC, effective February 24, 2022 (SPL set aedf70e4-1949-44bc-bf1b-0f282c4f0705), via openFDA; the full label on DailyMed
What do FAERS reports show for apomorphine?
The FDA Adverse Event Reporting System holds 804 reports that list apomorphine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 78 are coded as a death and 378 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as apomorphine?
1 other medicine is given the same way (subcutaneous) and in the same FDA class as apomorphine or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Foscarbidopa and foslevodopa | Parkinson's disease | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Apomorphine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other