Apomorphine

Short answer

Apomorphine is FDA-approved for "off" spells in advanced Parkinson's disease, as Apokyn shots and the Onapgo pump. For that use the evidence grade is strong-human. It is not approved for erectile dysfunction in the US. Taken with ondansetron, it can drop blood pressure and cause fainting.

Our assessment, drawn from the sources below.

What it is

Where it stands legally

What the evidence shows

Evidence grade: strong-human · our assessment

Known risks

• Taken with ondansetron or other 5-HT3 drugs for nausea, blood pressure can drop sharply and people have passed out. The labels say never to combine them ^{[1] [2]}.
• Nausea and vomiting are common and can be severe. The labels advise a drug for nausea before the first dose ^{[1] [2]}.
• People have fallen asleep during daily activities with no warning. Many feel sleepy on it ^{[1] [2]}.
• Blood pressure can drop on standing, and people can faint or fall. Alcohol and blood pressure drugs make the drop larger ^{[1] [2]}.
• It can change the heart's rhythm, measured as the QT interval. The labels warn this can lead to a deadly rhythm or sudden death ^{[1] [2]}.
• In the Apokyn studies, 4% of people had chest pain, a heart attack, cardiac arrest or sudden death ^[1].
• Given into a vein by mistake, it has caused blood clots that traveled to the lungs. It is only for use under the skin ^{[1] [2]}.
• It may cause hallucinations. Some people get strong urges to gamble, spend or have sex that they cannot control ^{[1] [2]}.
• It may cause hemolytic anemia, where red blood cells break down. Some people needed a hospital stay ^{[1] [3]}.
• It can cause jerky moves a person cannot stop, called dyskinesia. It can also make them worse ^{[1] [2]}.
• Some men have had painful erections that last too long, called priapism ^[1].
• The Onapgo pump can cause lumps, redness and infection where the needle goes in ^[2].
• The Kynmobi film often caused mouth and throat sores or swelling ^{[3] [14]}.
• Its sulfite can cause allergic reactions, which can be life-threatening in some people ^[1].
• Based on animal studies, it may harm an unborn baby ^{[1] [2]}.

What nobody knows yet

• It is not known if it is a good choice for erectile dysfunction. A 2020 review said more trials are needed on its effects and harms ^[17].
• A 2022 study of 40 people found the film did not change the QT interval much. The labels still warn about it, so the size of the risk is not settled ^{[16] [1]}.
• In long rat studies, it damaged the retina of the eye. The label says no one knows if this matters for people ^[1].
• The 2018 pump trial compared it with salt water for only 12 weeks. Its 52-week phase was open-label, and that paper reports only the first 12 weeks ^[15].
• Nobody knows yet how the Onapgo pump does in daily US life. A US study of people using it at home is still running ^[20].

Legitimate ways to get it

• Approved product

  Approved by FDA as a prescription shot under the skin, used as needed for "off" spells in advanced Parkinson's disease.

  Brand names: Apokyn

  Manufacturer: MDD US

  Indication: Acute, intermittent treatment of "off" episodes in advanced Parkinson's disease.

  accessdata.fda.gov

• Approved product

  Approved by FDA in 2025 as a prescription infusion under the skin by pump, through the waking day.

  Brand names: Onapgo

  Manufacturer: MDD US

  Indication: Treatment of motor fluctuations in adults with advanced Parkinson's disease.

  accessdata.fda.gov

• Lawful compounding

  Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.

  fda.gov

Sources

1. [1]Apokyn (apomorphine) injection label, revised January 2025Label · primary
2. [2]Onapgo (apomorphine) infusion label, revised May 2026Label · primary
3. [3]Kynmobi (apomorphine) sublingual film label, revised May 2022Label · primary
4. [4]Drugs@FDA: Apokyn (apomorphine) injection, application 021264Regulatory · primary
5. [5]Drugs@FDA: Onapgo (apomorphine) infusion, application 214056Regulatory · primary
6. [6]Drugs@FDA: Kynmobi (apomorphine) sublingual film, application 210875Regulatory · primary
7. [7]Federal Register: withdrawal of approval of 12 new drug applications, Kynmobi among them, 2025Regulatory · primary
8. [8]Federal Register: advisory subcommittee meeting on an apomorphine tablet for erectile dysfunction, 2000Regulatory · primary
9. [9]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
10. [10]FDA: 503A bulk drug substances category listRegulatory · primary
11. [11]21 CFR 1308.12: Schedule II, opiates excluding apomorphineRegulatory · primary
12. [12]FDA: understanding the risks of compounded drugsRegulatory · primary
13. [13]Randomized trial: apomorphine shots for "off" episodes in Parkinson's disease, 2001Rct · peer-reviewed
14. [14]Randomized phase 3 trial: apomorphine sublingual film for "off" episodes, 2020Rct · peer-reviewed
15. [15]Randomized trial (TOLEDO): apomorphine infusion in Parkinson's disease, 2018Rct · peer-reviewed
16. [16]Randomized thorough QT study of apomorphine sublingual film in Parkinson's disease, 2022Human trial · peer-reviewed
17. [17]Systematic review and meta-analysis: apomorphine for erectile dysfunction, 2020Systematic review · peer-reviewed
18. [18]Randomized crossover trial: sublingual apomorphine against sildenafil, 2008Rct · peer-reviewed
19. [19]Rat study: apomorphine, dopamine signaling in the brain and erection, 1999Animal · peer-reviewed
20. [20]ClinicalTrials.gov NCT07219927: patient experience with apomorphine infusion in the USReference · primary
21. [21]Pharmaceutical Technology: FDA approves an apomorphine infusion pump, February 2025Reference · established-news