Azilect Side Effects

Generic Name: rasagiline

Please note - some side effects for Azilect may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Azilect - for the Consumer

Azilect

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Azilect:

Diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms; headache; joint pain; lightheadedness; sleeplessness; stomach upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blood in the urine; blurred vision; changes in sexual ability or desire; chest pain; confusion; depression; enlarged pupils; fast or irregular heartbeat; fever; hallucinations; inability to sit still; numbness or tingling of the hands or feet; one-sided weakness; seizures; sensitivity to light; severe headache; skin changes; sore or stiff neck; tremor; trouble thinking or walking; unexplained nausea or vomiting; unusual sweating; vision or speech problems.

Azilect Side Effects - for the Professional

Azilect

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 events.  Therefore, most of the adverse events data in this section are presented separately for each population.

Patients receiving Azilect as initial monotherapy treatment

Adverse Events 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 events compared to  2% of the 151 patients who received placebo.

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

Adverse Event Incidence in Controlled Clinical Studies:

The most commonly observed adverse events that occurred in ≥ 5% of patients receiving Azilect 1 mg as monotherapy (n=149) participating in the double-blind, placebo-controlled trial and that were at least 1.5 times the incidence in the placebo group (n=151), were flu syndrome, arthralgia, depression, dyspepsia, and fall.

Table 6 lists treatment-emergent adverse events 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.

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 Events 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 events compared to 6% of the 159 patients who received placebo.  The AEs 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 Event Incidence in Controlled Clinical Studies:

The most commonly observed adverse events that occurred in ≥ 5% of patients receiving Azilect 1 mg (n=149) as adjunct to levodopa therapy participating in the double-blind, placebo-controlled trial (Study 1) and that were at least 1.5 times the incidence in the placebo group (n=159) in descending order of difference in incidence were dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, ecchymosis, somnolence and paresthesia.

Table 7 lists treatment-emergent adverse events 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.

Several of the more common adverse events seemed dose-related, including weight loss, postural hypotension, and dry mouth.

Other events 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 Events 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

Side Effects by Body System

General

General side effects have included accidental injury (10.1%), malaise, headache, fall, fever, flu syndrome, paresthesia, vertigo, hernia, sweating, somnolence, and weight loss.

Gastrointestinal

Gastrointestinal side effects have included nausea (7.2%), vomiting (3.7% to 6.7%), dyspepsia, gastroenteritis, diarrhea, anorexia, constipation, dry mouth, abdominal pain, and gingivitis.

Dermatologic

Dermatologic side effects have included ecchymosis, rash, pruritus, skin ulcer, eczema, urticaria, exfoliative dermatitis, leukoderma, and skin carcinoma.

Hematologic

Hematologic side effects have included hemorrhage, macrocytic anemia, purpura, and thrombocythemia.

Immunologic

Immunologic side effects have included infection (14.9%).

Cardiovascular

Cardiovascular side effects have included orthotopic hypertension (6%), postural hypotension, bundle branch block, heart failure, myocardial infarct, ventricular tachycardia, arterial thrombosis, atrial arrhythmia, complete AV block, second degree AV block, bigeminy, ventricular fibrillation, and peripheral edema.

Musculoskeletal

Musculoskeletal side effects have included dyskinesia (1%), arthralgia, myasthenia, tenosynovitis, neck pain, ataxia, dystonia, bone necrosis, muscle atrophy, and arthrosis.

Respiratory

Respiratory side effects have included dyspnea, increased cough, apnea, emphysema, laryngismus, pleural effusion, pneumothorax, interstitial pneumonia, larynx edema, lung fibrosis, and rhinitis.

Psychiatric

Psychiatric side effects have included hallucinations (1% to 3%) and abnormal dreams.

Genitourinary

Genitourinary side effects have included hematuria, urinary incontinence, dysmenorrhea, dysuria, nocturia, polyuria, scrotal edema, urinary retention, vaginal hemorrhage, vaginitis, vaginal moniliasis, abnormal ejaculation, amenorrhea, epididymitis, gynecomastia, hydroureter, leukorrhea, priapism, and urinary tract infection.

Metabolic

Metabolic side effects have included weight loss (2.4% to 9.4%) and hypocalcemia.

Nervous system

Nervous system side effects have included confusion (1%), headache, abnormal gait, anxiety, hyperkinesia, hypertonia, neuropathy, tremor, 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, and wrist drop. Apathy, delirium, hostility, manic depressive reaction, myelitis, neuralgia, psychotic depression and stupor have been reported rarely. Pain, back pain, dizziness, and balance difficulty have also been reported.

Oncologic

Oncologic side effects including melanoma have been reported.

Ocular

Ocular side effects including xerostomia and conjunctivitis have been reported.

Other

Other side effects have included asthenia (10.9%), accidental injury (10.1%), malaise, fall, flu syndrome, vertigo, and hernia.

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