FDA label 9eddc1b7-4b71-4145-b097-2b1cb1abee9e

5 WARNINGS AND PRECAUTIONS Enter section text here Risk of severe CNS toxicity (serotonin syndrome) when AZILECT is combined with antidepressants. ( 5.1 ) Concomitant use of ciprofloxacin or other CYP1A2 inhibitors: Increase in rasagiline plasma concentrations. 0.5 mg rasagiline once daily should not be exceeded ( 5.2 ) Patients with hepatic impairment: Increase in rasagiline plasma concentrations. Limit dose to 0.5 mg rasagiline in mild hepatic impairment. AZILECT should not be used in patients with moderate or severe hepatic impairment ( 5.3 ) Risk for Hypertensive Crisis and nonselective MAO inhibition above the recommended Doses ( 5.4 ) Melanoma ( 5.4 ) AZILECT may cause lower blood pressure, especially postural hypotension ( 5.7 ) or increase blood pressure in different patients ( 5.8 ) AZILECT may cause or exacerbate hallucinations or potentially other manifestations of psychotic-like behavior ( 5.9 ) 5.1 Coadministration with Antidepressants Severe CNS toxicity associated with hyperpyrexia has been reported with the combined treatment of an antidepressant (e.g., selective serotonin reuptake inhibitors-SSRIs, serotonin-norepinephrine reuptake inhibitors-SNRIs, tricyclic antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants) and a non-selective MAOI (e.g., phenelzine, tranylcypromine) or selective MAO-B inhibitors, such as selegiline (Eldepryl) and rasagiline (AZILECT). These adverse reactions are often described as "serotonin syndrome" which can result in death. In the post-marketing period, non-fatal cases of serotonin syndrome have been reported in patients treated with antidepressants concomitantly with AZILECT. The symptoms of serotonin syndrome have included behavioral and cognitive/mental status changes (e.g., confusion, hypomania, hallucinations, agitation, delirium, headache, and coma), autonomic effects (e.g., syncope, shivering, sweating, high fever/hyperthermia, hypertension, tachycardia, nausea, diarrhea), and somatic effects (e.g., muscular rigidity, myoclonus, muscle twitching, hyperreflexia manifested by clonus, and tremor). AZILECT clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with AZILECT, but the following antidepressants and doses were allowed in the AZILECT trials: amitriptyline ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily and paroxetine ≤ 30 mg/daily. Although a small number of rasagiline-treated patients were concomitantly exposed to antidepressants (tricyclics n=115; SSRIs n=141), the exposure, both in dose and number of subjects, was not adequate to rule out the possibility of an untoward reaction from combining these agents. Furthermore, because the mechanisms of these reactions are not fully understood, it seems prudent, in general, to avoid the combination of AZILECT with any antidepressant. At least 14 days should elapse between discontinuation of AZILECT and initiation of treatment with a SSRI, SNRI, tricyclic, tetracyclic, or triazolopyridine antidepressant. Because of the long half lives of certain antidepressants (e.g., fluoxetine and its active metabolite), at least five weeks (perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses) should elapse between discontinuation of fluoxetine and initiation of AZILECT [see Drug Interactions (7.5) ]. 5.2 Ciprofloxacin and Other CYP1A2 Inhibitors Rasagiline plasma concentrations may increase up to 2 fold in patients using concomitant ciprofloxacin and other CYP1A2 inhibitors [see Dosage and Administration (2.5) , Drug Interactions (7.7) , and Clinical Pharmacology (12.3) ] . 5.3 Hepatic Impairment Rasagiline plasma concentration may increase in patients with mild (up to 2 fold, Child-Pugh score 5-6), moderate (up to 7 fold, Child-Pugh score 7-9), and severe (Child-Pugh score 10-15) hepatic impairment. Patients with mild hepatic impairment should be given the dose of 0.5 mg/day. AZILECT should not be used in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] . 5.4 Risk for Hypertensive Crisis and Nonselective Monoamine Oxidase Inhibition Above The Recommended Doses AZILECT is a selective inhibitor of monoamine oxidase (MAO)-B at the recommended doses of 0.5 or 1 mg daily. AZILECT should not be used at daily doses exceeding 1 mg/day (or 0.5 mg/day for patients with mild hepatic impairment or in patients using concomitant ciprofloxacin or another CYP1A2 inhibitor) because of the risks of hypertensive crisis and other adverse reactions associated with nonselective inhibition of MAO [see Dosage and Administration (2) , Drug Interactions (7.9) , and Clinical Pharmacology (12.3) ] . Dietary tyramine restriction is not ordinarily required with ingestion of most foods and beverages that may contain tyramine, during treatment with recommended doses of AZILECT. However, certain foods (e.g., aged cheeses, such as Stilton cheese) may contain very high amounts (i.e., > 150 mg) of tyramine and could potentially cause a hypertensive "cheese" reaction in patients taking AZILECT even at the recommended doses due to mild increased sensitivity to tyramine. Patients should be advised to avoid foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of AZILECT because of the potential for large increases in blood pressure. Selectivity for inhibiting MAO-B diminishes in a dose-related manner as the dose is progressively increased above the recommended daily doses. There were no cases of hypertensive crisis in the clinical development program associated with 1 mg daily rasagiline treatment, in which most patients did not follow dietary tyramine restriction. Rare cases of hypertensive crisis have been reported in the post-marketing period in patients after ingesting unknown amounts of tyramine-rich foods while taking recommended doses of AZILECT. 5.5 Melanoma Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists). 5.6 Dyskinesia When used as an adjunct to levodopa, AZILECT may cause dyskinesia or potentiate dopaminergic side effects and exacerbate pre-existing dyskinesia (treatment-emergent dyskinesia occurred in about 18% of patients treated with 0.5 mg or 1 mg rasagiline as an adjunct to levodopa, and 10% of patients who received placebo as an adjunct to levodopa). Decreasing the dose of levodopa may ameliorate this side effect. 5.7 Lowering of Blood Pressure and Postural/Orthostatic Hypotension In placebo controlled studies of AZILECT given in combination with levodopa, the incidence of postural hypotension consisting of a systolic blood pressure decrease ( > 30 mm Hg) or a diastolic blood pressure decrease ( > 20 mm Hg) after standing was 13.4 % with AZILECT (1 mg/day) compared to 8.5 % with placebo. At the 1 mg dose, the frequency of orthostatic hypotension at any time during the study was approximately 44 % for AZILECT vs 33% for placebo for mild to moderate systolic blood pressure decrements ( > 20 mm Hg), 40 % for AZILECT vs 33 % for placebo for mild to moderate diastolic blood pressure decrements ( > 10 mm Hg), 7 % for AZILECT vs 3 % for placebo for severe systolic blood pressure decrements ( > 40 mm Hg), and 9 % for AZILECT vs 6 % for placebo for severe diastolic blood pressure decrements ( > 20 mm Hg). There was also an increased risk for some of these abnormalities at the lower 0.5 mg daily dose and for an individual patient having mild to moderate or severe postural hypotension for both systolic and diastolic blood pressure. Clinical trial data further suggest that postural hypotension occurs most frequently in the first two months of AZILECT treatment and tends to decrease over time. Some patients treated with AZILECT experienced a mildly increased risk for significant decreases in blood pressure unrelated to standing but while supine. The risk for post-treatment hypotension (e.g., systolic < 90 or diastolic < 50 mm Hg) combined with a significant decrease from baseline (e.g., systolic > 30 or diastolic > 20 mm Hg) was higher for AZILECT 1 mg (3.2 %) compared to placebo (1.3 %). There was no clear increased risk for lowering of blood pressure or postural hypotension associated with AZILECT 1 mg/day as monotherapy. When used as an adjunct to levodopa, postural hypotension was also reported as an adverse reaction in approximately 6% of patients treated with 0.5 mg rasagiline, 9% of patients treated with 1 mg rasagiline and 3% of patients treated with placebo. Postural hypotension led to drug discontinuation and premature withdrawal from clinical trials in one (0.7%) patient treated with rasagiline 1 mg/day, no patients treated with rasagiline 0.5 mg/day and no placebo-treated patients. 5.8 Elevation of Blood Pressure In studies in which AZILECT (1 mg/day) was given in conjunction with levodopa, AZILECT produced an increased incidence of a significant, high blood pressure (e.g., systolic > 180 or diastolic > 100 mm Hg) of 4% compared to 3% for placebo. The risk for developing post-treatment high blood pressure (e.g., systolic > 180 or diastolic >100 mm Hg) combined with a significant increase from baseline (e.g., systolic > 30 or diastolic > 20 mm Hg) was higher for AZILECT (2 %) compared to placebo (1 %). There was no increased frequency of the incidence of hypertension as an adverse reaction in the adjunctive treatment pivotal trials for AZILECT treatment vs placebo. There was no observed increased risk for increasing blood pressure or high blood pressure (based upon various measurements and analyses) or for the development of hypertension as an adverse reaction in the monotherapy study for 1 mg daily AZILECT treatment (vs placebo). 5.9 Hallucinations / Psychotic-Like Behavior In the monotherapy study, hallucinations were reported as an adverse event in 1.3% of patients treated with 1 mg rasagiline and in 0.7% of patients treated with placebo. In the monotherapy trial, hallucinations led to drug discontinuation and premature withdrawal from clinical trials in 1.3% of the 1 mg rasagiline-treated patients and in none of the placebo-treated patients. When used as an adjunct to levodopa, hallucinations were reported as an adverse reaction in approximately 5% of patients treated with 0.5 mg/day AZILECT, 4% of patients treated with 1 mg/day AZILECT and 3% of patients treated with placebo. Hallucinations led to drug discontinuation and premature withdrawal from clinical trials in about 1% of patients treated with 0.5 mg/day or 1 mg/day rasagiline and none of the placebo-treated patients. Patients should be informed of the possibility of developing hallucinations and instructed to report them to their health care provider promptly should they develop. Patients with a major psychotic disorder should ordinarily not be treated with AZILECT because of the risk of exacerbating the psychosis with an increase in central dopaminergic tone. In addition, many treatments for psychosis that decrease in central dopaminergic tone may decrease the effectiveness of AZILECT. AZILECT administration may cause or exacerbate psychotic-like behavior based upon post-marketing reports. This adverse reaction has been reported with many anti-Parkinsonian drugs that increase central dopaminergic tone. This abnormal behavior has been exhibited by one or more of a variety of manifestations including paranoia, confusional state/confusion, psychotic disorder, agitation, delusion, and hallucinations. 5.10 Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in drugs that increase central dopaminergic tone. [see Dosage and Administration (2.2) ] . Withdrawal emergent hyperpyrexia was not reported in the AZILECT clinical development program. 5.11 Laboratory Tests No specific laboratory tests are required for the treatment of patients on AZILECT.

6 ADVERSE REACTIONS Enter section text here Most common adverse reactions (treatment difference ≥ 3% greater than placebo); with monotherapy: flu syndrome, arthralgia, depression, dyspepsia. ( 6.1 ) Most common adverse reactions (treatment difference ≥ 3% greater than placebo); when 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TEVA at 1-800-221-4026 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience During the clinical development of AZILECT, 1361 Parkinson's disease patients received rasagiline as initial monotherapy or as adjunct therapy to levodopa. As these two populations differ, not only in the adjunct use of levodopa during rasagiline treatment, but also in the severity and duration of their disease, they may have differential risks for various adverse reactions. Therefore, most of the adverse reactions data in this section are presented separately for each population. 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 rates in the clinical trials of another drug and may not reflect the rates of adverse reactions observed in practice. Patients Receiving AZILECT as Initial Monotherapy Treatment Adverse Reactions Leading to Discontinuation in Controlled Clinical Studies In the double-blind, placebo-controlled trials conducted in patients receiving AZILECT as monotherapy, approximately 5% of the 149 patients treated with rasagiline 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. Adverse Reaction Incidence in Controlled Clinical Studies The most commonly observed adverse reactions were those in which the treatment difference for the incidence in AZILECT-treated patients was ≥ 3 % greater than the incidence in the placebo-treated patients and included flu syndrome, arthralgia, depression, and dyspepsia. Table 1 lists treatment-emergent adverse reactions that occurred in ≥ 2% of patients receiving AZILECT as monotherapy participating in the double-blind, placebo-controlled trial and were numerically more frequent than in the placebo group. Table 1. Treatment-Emergent * Adverse Reactions in AZILECT 1 mg-Treated Monotherapy Patients Placebo-Controlled Studies Without Levodopa Treatment AZILECT 1 mg (N=149) Placebo (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 * Incidence ≥ 2% in AZILECT 1 mg group and numerically more frequent than in placebo group Other events of potential clinical importance reported by 1% or more of patients receiving AZILECT as monotherapy, and at least as frequent as in the placebo group, in descending order of frequency include: dizziness, diarrhea, chest pain, albuminuria, allergic reaction, alopecia, angina pectoris, anorexia, asthma, hallucinations, impotence, leukopenia, libido decreased, liver function tests abnormal, skin carcinoma, syncope, vesiculobullous rash, vomiting. There were no significant differences in the safety profile based on age or gender. Patients Receiving AZILECT as Adjunct to Levodopa Therapy Adverse Reactions Leading to Discontinuation in Controlled Clinical Studies In a double-blind, placebo-controlled trial (Study 1) conducted in patients treated with AZILECT as adjunct to levodopa therapy, approximately 9% of the 164 patients treated with AZILECT 0.5 mg/day and 7% of the 149 patients treated with AZILECT 1 mg/day discontinued treatment due to adverse reactions compared to 6% of the 159 patients who received placebo. The adverse reactions that led to discontinuation of more than one rasagiline-treated patient were: diarrhea, weight loss, hallucination, and rash. Adverse event reporting was considered more reliable for Study 1 than for the second controlled trial (Study 2); therefore only the adverse event data from Study 1 are presented in this section of labeling. Adverse Reactions: Incidence in Controlled Clinical Studies The most commonly observed adverse reactions were those in which the treatment difference for the incidence in AZILECT-treated patients (n=149) was ≥ 3 % greater than the incidence in the placebo-treated patients (n=159) and included dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall. Table 2 lists treatment-emergent adverse reactions that occurred in ≥ 2% of patients treated with AZILECT 1 mg/day as adjunct to levodopa therapy participating in the double-blind, placebo-controlled trial (Study 1) and that were numerically more frequent than the placebo group. The table also shows the rates for the 0.5 mg group in Study 1. Table 2. Incidence of Treatment-Emergent * Adverse Reactions in Patients Receiving AZILECT as Adjunct to Levodopa Therapy in Study 1 AZILECT 1 mg + Levodopa (N=149) AZILECT 0.5 mg + Levodopa (N=164) Placebo + Levodopa (N=159) % of patients % of patients % 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 Sweating 3 2 1 Tenosynovitis 3 1 0 Dystonia 3 2 1 Gingivitis 2 1 1 Hemorrhage 2 1 1 Hernia 2 1 1 Myasthenia 2 2 1 * Incidence ≥ 2% in AZILECT 1 mg group and numerically more frequent than in placebo group Several of the more common adverse reactions seemed dose-related, including weight loss, postural hypotension, and dry mouth. Other adverse reactions of potential clinical importance reported in Study 1 by 1% or more of patients treated with rasagiline 1 mg/day as adjunct to levodopa therapy, and at least as frequent as in the placebo group, in descending order of frequency include : skin carcinoma, anemia, albuminuria, amnesia, arthritis, bursitis, cerebrovascular accident, confusion, dysphagia, epistaxis, leg cramps, pruritus, skin ulcer. There were no significant differences in the safety profile based on age or gender. Other Adverse Reactions Observed During All Phase 2/3 Clinical Trials Rasagiline was administered to approximately 1361 patients during all PD phase 2/3 clinical trials. About 283 patients received rasagiline for at least one year, approximately 410 patients received rasagiline for at least two years, 116 patients received rasagiline for at least 3 years, and 245 patients received rasagiline for more than 3 years, with some patients treated for more than 5 years. The long-term safety profile was similar to that observed with shorter duration exposure. The frequencies listed below represent the proportion of the 1361 individuals exposed to rasagiline who experienced events of the type cited. All events that occurred at least twice (or once for serious or potentially serious events), except those already listed above, trivial events, terms too vague to be meaningful, adverse events with no plausible relation to treatment, and events that would be expected in patients of the age studied, were reported without regard to determination of a causal relationship to rasagiline. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are defined as those occurring in at least 1/100 to 1/1000 patients and rare adverse events are defined as those occurring in fewer than 1/1000 patients. Body as a whole: Frequent: asthenia Infrequent: chills, face edema, flank pain, photosensitivity reaction Cardiovascular system: Frequent: bundle branch block Infrequent: deep thrombophlebitis, heart failure, migraine, myocardial infarct, phlebitis, ventricular tachycardia Rare: arterial thrombosis, atrial arrhythmia, AV block complete, AV block second degree, bigeminy, cerebral hemorrhage, cerebral ischemia, ventricular fibrillation Digestive system: Frequent: gastrointestinal hemorrhage Infrequent: colitis, esophageal ulcer, esophagitis, fecal incontinence, intestinal obstruction, mouth ulceration, stomach ulcer, stomatitis, tongue edema Rare: hematemesis, hemorrhagic gastritis, intestinal perforation, intestinal stenosis, jaundice, large intestine perforation, megacolon, melena Hemic and Lymphatic system: Infrequent: macrocytic anemia Rare: purpura, thrombocythemia Metabolic and Nutritional disorders: Infrequent: hypocalcemia Musculoskeletal system: Infrequent: bone necrosis, muscle atrophy Rare: arthrosis Nervous system: Frequent: abnormal gait, anxiety, hyperkinesia, hypertonia, neuropathy, tremor Infrequent: agitation, aphasia, circumoral paresthesia, convulsion, delusions, dementia, dysarthria, dysautonomia, dysesthesia, emotional lability, facial paralysis, foot drop, hemiplegia, hypesthesia, incoordination, manic reaction, myoclonus, neuritis, neurosis, paranoid reaction, personality disorder, psychosis, wrist drop Rare: apathy, delirium, hostility, manic depressive reaction, myelitis, neuralgia, psychotic depression, stupor Respiratory system: Frequent: cough increased Infrequent: apnea, emphysema, laryngismus, pleural effusion, pneumothorax Rare: interstitial pneumonia, larynx edema, lung fibrosis Skin and Appendages: Infrequent: eczema, urticaria Rare: exfoliative dermatitis, leukoderma Special senses: Infrequent: blepharitis, deafness, diplopia, eye hemorrhage, eye pain, glaucoma, keratitis, ptosis, retinal degeneration, taste perversion, visual field defect Rare: blindness, parosmia, photophobia, retinal detachment, retinal hemorrhage, strabismus, taste loss, vestibular disorder Urogenital system: Frequent: hematuria, urinary incontinence Infrequent: acute kidney failure, dysmenorrhea, dysuria, kidney calculus, nocturia, polyuria, scrotal edema, sexual function abnormal, urinary retention, urination impaired, vaginal hemorrhage, vaginal moniliasis, vaginitis Rare: abnormal ejaculation, amenorrhea, anuria, epididymitis, gynecomastia, hydroureter, leukorrhea, priapism 6.2 Post-marketing Experience The following adverse events not described in sections 4 and 5 have been identified during the post-marketing/post-approval use of AZILECT. Because these adverse events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency nor to establish unequivocally a causal relationship to drug exposure: Increased libido including hypersexuality, impulse control symptoms, pathological gambling [see Patient Counseling Information (17.11) ]

<table width="80%" ID="i5dca6a1b-f4bc-4194-80ac-ff9c7bf748cb"> <caption>Table 1. Treatment-Emergent<linkHtml href="#footnote-1">*</linkHtml> Adverse Reactions in AZILECT 1 mg-Treated Monotherapy Patients</caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="30%"/> <col align="center" valign="top" width="30%"/> <thead> <tr> <th>Placebo-Controlled Studies Without Levodopa Treatment</th> <th>AZILECT 1 mg (N=149)</th> <th>Placebo (N=151)</th> </tr> <tr> <th> </th> <th>% of Patients</th> <th>% of Patients</th> </tr> </thead> <tbody> <tr> <td>Headache</td> <td>14</td> <td>12</td> </tr> <tr> <td>Arthralgia</td> <td>7</td> <td>4</td> </tr> <tr> <td>Dyspepsia</td> <td>7</td> <td>4</td> </tr> <tr> <td>Depression</td> <td>5</td> <td>2</td> </tr> <tr> <td>Fall</td> <td>5</td> <td>3</td> </tr> <tr> <td>Flu syndrome</td> <td>5</td> <td>1</td> </tr> <tr> <td>Conjunctivitis</td> <td>3</td> <td>1</td> </tr> <tr> <td>Fever</td> <td>3</td> <td>1</td> </tr> <tr> <td>Gastroenteritis</td> <td>3</td> <td>1</td> </tr> <tr> <td>Rhinitis</td> <td>3</td> <td>1</td> </tr> <tr> <td>Arthritis</td> <td>2</td> <td>1</td> </tr> <tr> <td>Ecchymosis</td> <td>2</td> <td>0</td> </tr> <tr> <td>Malaise</td> <td>2</td> <td>0</td> </tr> <tr> <td>Neck Pain</td> <td>2</td> <td>0</td> </tr> <tr> <td>Paresthesia</td> <td>2</td> <td>1</td> </tr> <tr> <td>Vertigo</td> <td>2</td> <td>1</td> </tr> </tbody> </table>

<table width="80%" ID="iedc81b62-9946-416d-8400-27d77e9ccba5"> <caption>Table 2. Incidence of Treatment-Emergent<linkHtml href="#footnote-2">*</linkHtml> Adverse Reactions in Patients Receiving AZILECT as Adjunct to Levodopa Therapy in Study 1</caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <thead> <tr> <th> </th> <th>AZILECT 1 mg + Levodopa (N=149)</th> <th>AZILECT 0.5 mg + Levodopa (N=164)</th> <th>Placebo + Levodopa (N=159)</th> </tr> <tr> <th> </th> <th>% of patients</th> <th>% of patients</th> <th>% of patients</th> </tr> </thead> <tbody> <tr> <td>Dyskinesia</td> <td>18</td> <td>18</td> <td>10</td> </tr> <tr> <td>Accidental injury</td> <td>12</td> <td>8</td> <td>5</td> </tr> <tr> <td>Nausea</td> <td>12</td> <td>10</td> <td>8</td> </tr> <tr> <td>Headache</td> <td>11</td> <td>8</td> <td>10</td> </tr> <tr> <td>Fall</td> <td>11</td> <td>12</td> <td>8</td> </tr> <tr> <td>Weight loss</td> <td>9</td> <td>2</td> <td>3</td> </tr> <tr> <td>Constipation</td> <td>9</td> <td>4</td> <td>5</td> </tr> <tr> <td>Postural hypotension</td> <td>9</td> <td>6</td> <td>3</td> </tr> <tr> <td>Arthralgia</td> <td>8</td> <td>6</td> <td>4</td> </tr> <tr> <td>Vomiting</td> <td>7</td> <td>4</td> <td>1</td> </tr> <tr> <td>Dry mouth</td> <td>6</td> <td>2</td> <td>3</td> </tr> <tr> <td>Rash</td> <td>6</td> <td>3</td> <td>3</td> </tr> <tr> <td>Somnolence</td> <td>6</td> <td>4</td> <td>4</td> </tr> <tr> <td>Abdominal pain</td> <td>5</td> <td>2</td> <td>1</td> </tr> <tr> <td>Anorexia</td> <td>5</td> <td>2</td> <td>1</td> </tr> <tr> <td>Diarrhea</td> <td>5</td> <td>7</td> <td>4</td> </tr> <tr> <td>Ecchymosis</td> <td>5</td> <td>2</td> <td>3</td> </tr> <tr> <td>Dyspepsia</td> <td>5</td> <td>4</td> <td>4</td> </tr> <tr> <td>Paresthesia</td> <td>5</td> <td>2</td> <td>3</td> </tr> <tr> <td>Abnormal dreams</td> <td>4</td> <td>1</td> <td>1</td> </tr> <tr> <td>Hallucinations</td> <td>4</td> <td>5</td> <td>3</td> </tr> <tr> <td>Ataxia</td> <td>3</td> <td>6</td> <td>1</td> </tr> <tr> <td>Dyspnea</td> <td>3</td> <td>5</td> <td>2</td> </tr> <tr> <td>Infection</td> <td>3</td> <td>2</td> <td>2</td> </tr> <tr> <td>Neck pain</td> <td>3</td> <td>1</td> <td>1</td> </tr> <tr> <td>Sweating</td> <td>3</td> <td>2</td> <td>1</td> </tr> <tr> <td>Tenosynovitis</td> <td>3</td> <td>1</td> <td>0</td> </tr> <tr> <td>Dystonia</td> <td>3</td> <td>2</td> <td>1</td> </tr> <tr> <td>Gingivitis</td> <td>2</td> <td>1</td> <td>1</td> </tr> <tr> <td>Hemorrhage</td> <td>2</td> <td>1</td> <td>1</td> </tr> <tr> <td>Hernia</td> <td>2</td> <td>1</td> <td>1</td> </tr> <tr> <td>Myasthenia</td> <td>2</td> <td>2</td> <td>1</td> </tr> </tbody> </table>