What the label lists and what reports show
Apomorphine side effects
Apomorphine's FDA label: “Most common adverse reactions (incidence at least 10% greater on apomorphine hydrocloride than on placebo) were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucination/confusion, and …” FAERS holds 804 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypotension (88 reports).
- Generic listed
Check it at the source: the apomorphine FDA label on DailyMed (effective February 24, 2022, TruPharma, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of apomorphine hydrocloride injection?Apomorphine hydrocloride injection may cause serious side effects. Call your healthcare provider right away if you have any of the serious side effects, including: allergic reaction. An allergic reaction with side effects of hives, itching, rash, swelling (e.g., eyes, tongue, etc.); trouble breathing and/or swallowing may occur after injecting apomorphine hydrocloride injection. blood clots. Injecting apomorphine hydrocloride injection into a vein (intravenous) can cause blood clots. Do not inject apomorphine hydrocloride injection in your vein. nausea and vomiting. Severe nausea and vomiting can happen with apomorphine hydrocloride injection. Your healthcare provider may prescribe a medicine called trimethobenzamide (Tigan ® ) to help prevent nausea and vomiting. Some patients can stop taking Tigan after using apomorphine hydrocloride injection for several months. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (incidence at least 10% greater on apomorphine hydrocloride than on placebo) were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucination/confusion, and edema/swelling of extremities ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TruPharma, LLC at 877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Adverse Reactions Occurring in Two or More Apomorphine Hydrocloride-Treated Patients in Study 1
| Reaction | Apomorphine Hydrocloride (n = 20) % | PLACEBO (n = 9) % |
|---|---|---|
| Yawning | 40 | 0 |
| Dyskinesias | 35 | 11 |
| Drowsiness or Somnolence | 35 | 0 |
| Nausea and/or Vomiting | 30 | 11 |
| Dizziness or Postural Hypotension | 20 | 0 |
| Rhinorrhea | 20 | 0 |
| Chest Pain/Pressure/Angina | 15 | 11 |
| Hallucination or Confusion | 10 | 0 |
| Edema/Swelling of Extremities | 10 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling: Serious Adverse Reactions After Intravenous Administration [see Warnings and Precautions (5.1) ] Nausea and Vomiting [see Warnings and Precautions (5.2) ] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.3) ] Syncope/Hypotension/Orthostatic Hypotension [see Warnings and Precautions (5.4) ] Falls [see Warnings and Precautions (5.5) ] Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.6) ] Dyskinesias [see Warnings and Precautions (5.7) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.8) ] Coronary Events [see Warnings and Precautions (5.9) ] QTc Prolongation and Potential for Proarrhythymic Effects [see Warnings and Precautions (5.10) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.11) ] Hypersensitivity [see Warnings and Precautions (5.12) ] Fibrotic Complications [see Warnings and Precautions (5.13) ] Priapism [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence at least 10% greater on apomorphine hydrocloride than on placebo) were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucination/confusion, and edema/swelling of extremities ( 6.1 …
Source: FDA drug label, 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?
804 reports list apomorphine among the medicines taken, 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. Of the 24 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Apomorphine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions