What the label lists and what reports show
Selegiline side effects
Selegiline's FDA label lists its adverse reactions in its own words. FAERS holds 3,527 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 hallucination (230 reports).
- Generic listed
Check it at the source: the selegiline FDA label on DailyMed (effective August 7, 2024, Rising Pharma Holdings, Inc.); 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 EMSAM?EMSAM may cause serious side effects, including: • See “What is the most important information I should know about EMSAM?” • serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you use EMSAM while you take certain medicines called MAOIs. Symptoms of serotonin syndrome include: o agitation o coma o dizziness o fever o stiff muscles o nausea o seeing things that are not there (hallucinations) o rapid pulse o sweating o seizures o muscle twitching o vomiting o confusion o low blood pressure o flushing o tremors o become unstable o diarrhea If you suddenly have these symptoms, stop using EMSAM immediately by removing the patch and go to the nearest hospital emergency room right away. • a sudden, severe increase in blood pressure (hypertensive crisis). […]
Source: FDA drug label (EMSAM), Viatris Specialty LLC, effective May 15, 2020 (SPL set b891bd9f-fdb8-4862-89c5-ecdd700398a3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIntroduction The number of patients who received selegiline in prospectively monitored pre-marketing studies is limited. While other sources of information about the use of selegiline are available (e.g., literature reports, foreign post-marketing reports, etc.) they do not provide the kind of information necessary to estimate the incidence of adverse events. Thus, overall incidence figures for adverse reactions associated with the use of selegiline cannot be provided. Many of the adverse reactions seen have also been reported as symptoms of dopamine excess. Moreover, the importance and severity of various reactions reported often cannot be ascertained. One index of relative importance, however, is whether or not a reaction caused treatment discontinuation. …
Table 1: Adverse Reactions Patients may have reported multiple adverse experiences during the study or at discontinuation; thus patients may be included in more than one category. in Double-Blind, Placebo-Controlled…
This table is printed in the ZELAPAR label published by Bausch Health US, LLC of June 1, 2021; the label quoted above does not print one.
| Body System/ Adverse Event | ZELAPAR 1.25/2.5 mg N=194 % | Placebo N=98 % |
|---|---|---|
| Pain | 8 | 7 |
| Back Pain | 5 | 3 |
| Chest Pain | 2 | 0 |
| Hypertension | 3 | 2 |
| Nausea | 11 | 9 |
| Stomatitis | 5 | 4 |
| Dyspepsia | 5 | 3 |
| Constipation | 4 | 0 |
| Vomiting | 3 | 0 |
| Diarrhea | 2 | 1 |
| Dysphagia | 2 | 1 |
| Flatulence | 2 | 1 |
| Tooth Disorder | 2 | 1 |
| Ecchymosis | 2 | 0 |
| Hypokalemia | 2 | 0 |
| Leg Cramps | 3 | 1 |
| Myalgia | 3 | 0 |
| Dizziness | 11 | 8 |
| Headache | 7 | 6 |
| Insomnia | 7 | 4 |
| Dyskinesia | 6 | 3 |
| Dry Mouth | 4 | 2 |
| Hallucinations | 4 | 2 |
| Somnolence | 3 | 2 |
| Tremor | 3 | 1 |
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.
Source: FDA drug label, Rising Pharma Holdings, Inc., effective August 7, 2024 (SPL set 23c4481f-d150-40c6-addb-b3e454ca914f), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,527 reports list selegiline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 233 are coded as a death and 834 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 18 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?
- Selegiline: 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