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.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Azilect:Constipation, diarrhea; drowsiness; dry mouth; flu-like symptoms; headache; joint pain; loss of appetite, mild stomach pain; stomach upset; stuffy nose; weight loss.
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 or other vision changes; burning, numbness, or tingling; changes in sexual ability or desire; chest pain; confusion; decreased coordination; enlarged pupils; eye pain or inflammation; fainting; fast or irregular heartbeat; fever; hallucinations; inability to sit still; mental or mood changes (eg, agitation, depression, paranoia); one-sided weakness; seizures; sensitivity to light; severe or persistent headache, dizziness, or light-headedness; severe or persistent stomach pain or diarrhea; shortness of breath; skin changes; sore or stiff neck; speech problems; stiff muscles; tremor; trouble thinking or walking; unexplained nausea or vomiting; unusual sweating.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAzilect Side Effects - for the Professional
Azilect
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.
| 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 |
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.
| 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 |
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
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)]
TopSide Effects by Body System - for Healthcare Professionals
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.
TopMore Azilect resources
- Azilect Prescribing Information (FDA)
- Azilect Monograph (AHFS DI)
- Azilect Advanced Consumer (Micromedex) - Includes Dosage Information
- Azilect Consumer Overview
- Azilect MedFacts Consumer Leaflet (Wolters Kluwer)
- Rasagiline Professional Patient Advice (Wolters Kluwer)
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