Rasagiline Side Effects

6 ADVERSE REACTIONS The 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 Torrent Pharma Inc.

at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the rates of adverse reactions observed in practice.

During the clinical development of rasagiline tablets, Parkinson's disease patients received rasagiline tablets as initial monotherapy (Study 1) and as adjunct therapy (Study 2, Study 3, Study 4).

As the populations in these studies differ, not only in the adjunct use of dopamine agonists or levodopa during rasagiline treatment, but also in the severity and duration of their disease, the adverse reactions are presented separately for each study.

Monotherapy Use of Rasagiline Tablets In Study 1, approximately 5% of the 149 patients treated with rasagiline tablets discontinued treatment due to adverse reactions compared to 2% of the 151 patients who received placebo.

The only adverse reaction that led to the discontinuation of more than one patient was hallucinations.

The most commonly observed adverse reactions in Study 1 (incidence in rasagiline tablets -treated patients 3% or greater than the incidence in placebo-treated patients) included flu syndrome, arthralgia, depression, and dyspepsia.

Table 1 lists adverse reactions that occurred in 2% or greater of patients receiving rasagiline tablets as monotherapy and were numerically more frequent than in the placebo group in Study

Table 1: Adverse Reactions* in Study 1 *Incidence 2% or greater in rasagiline tablets 1 mg group and numerically more frequent than in placebo group Rasagiline tablets 1 mg (N=149) P l acebo (N=151) % of Patients % of Patients Headache 14 12 Arthralgia 7 4 Dyspepsia 7 4 Depression 5 2 Fall 5 3 Flu syndrome 5 1 Conjunctivitis 3 1 Fever 3 1 Gastroenteritis 3 1 Rhinitis 3 1 Arthritis 2 1 Ecchymosis 2 0 Malaise 2 0 Neck Pain 2 0 Paresthesia 2 1 Vertigo 2 1 There were no significant differences in the safety profile based on age or gender.