What the label lists and what reports show
Rasagiline side effects
Rasagiline's FDA label: “Most common adverse reactions (incidence 3% or greater than placebo): Rasagiline monotherapy: flu syndrome, arthralgia, depression, dyspepsia ( 6.1 ) Rasagiline used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia ( 6.1 ) …” FAERS holds 11,067 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 fall (1,066 reports).
- Generic listed
Check it at the source: the rasagiline FDA label on DailyMed (effective June 30, 2020, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence 3% or greater than placebo): Rasagiline monotherapy: flu syndrome, arthralgia, depression, dyspepsia ( 6.1 ) Rasagiline used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia ( 6.1 ) Rasagiline used as adjunct to levodopa: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis
Table 3: Adverse Reactions* in Study 3
| Reaction | Rasagiline 1 mg (N=149) % of Patients | Rasagiline 0.5 mg (N=164) % of Patients | Placebo (N=159) % of Patients |
|---|---|---|---|
| Dyskinesia | 18 | 18 | 10 |
| Accidental injury | 12 | 8 | 5 |
| Nausea | 12 | 10 | 8 |
| Headache | 11 | 8 | 10 |
| Fall | 11 | 12 | 8 |
| Weight loss | 9 | 2 | 3 |
| Constipation | 9 | 4 | 5 |
| Postural hypotension | 9 | 6 | 3 |
| Arthralgia | 8 | 6 | 4 |
| Vomiting | 7 | 4 | 1 |
| Dry mouth | 6 | 2 | 3 |
| Rash | 6 | 3 | 3 |
| Somnolence | 6 | 4 | 4 |
| Abdominal pain | 5 | 2 | 1 |
| Anorexia | 5 | 2 | 1 |
| Diarrhea | 5 | 7 | 4 |
| Ecchymosis | 5 | 2 | 3 |
| Dyspepsia | 5 | 4 | 4 |
| Paresthesia | 5 | 2 | 3 |
| Abnormal dreams | 4 | 1 | 1 |
| Hallucinations | 4 | 5 | 3 |
| Ataxia | 3 | 6 | 1 |
| Dyspnea | 3 | 5 | 2 |
| Infection | 3 | 2 | 2 |
| Neck pain | 3 | 1 | 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.
From the label: adverse reactions, continuedThe following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Hypertension [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.3 )] Hypotension / Orthostatic Hypotension [see Warnings and Precautions ( 5.6 )] Dyskinesia [see Warnings and Precautions ( 5.7 )] Hallucinations / Psychotic-Like Behavior [see Warnings and Precautions ( 5.8 )] Impulse Control /Compulsive Behaviors [see Warnings and Precautions ( 5.9 )] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence 3% or greater than placebo): Rasagiline monotherapy: flu syndrome, arthralgia, depression, dyspepsia ( 6.1 ) Rasagiline used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia ( 6.1 ) Rasagiline used as adjunct to levodopa: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective June 30, 2020 (SPL set e802c83c-e581-4a11-b83d-1df47120078d), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,067 reports list rasagiline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,236 are coded as a death and 3,592 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 21 reactions below, 9 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?
- Rasagiline: 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