Azilect

Azilect Adverse Reactions

rasagiline

Manufacturer:

Lundbeck

Distributor:

Metro Drug
Full Prescribing Info
Adverse Reactions
In the rasagiline clinical program, overall 1,361 patients were treated with rasagiline for 3,076.4 patient years. In the double-blind, placebo-controlled studies, 529 patients were treated with rasagiline 1 mg/day for 212 patient years and 539 patients received placebo for 213 patient years.
Monotherapy: The following list includes adverse reactions which were reported with a higher incidence in placebo-controlled studies in patients receiving rasagiline 1 mg/day (rasagiline group n=149, placebo group n=151).
Adverse reactions are ranked under headings of frequency using the following conventions: Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000). In parentheses is the adverse reaction incidence (% of patients) in rasagiline versus placebo, respectively.
Infections and Infestations: Common: Influenza* (4.7% vs 0.7%).
Benign, Malignant and Unspecified Neoplasms (Including Cysts and Polyps): Common: Skin carcinoma (1.3% vs 0.7%).
Blood and Lymphatic System Disorders: Common: Leucopenia (1.3% vs 0%).
Immune System Disorders: Common: Allergy (1.3% vs 0.7%).
Metabolism and Nutrition Disorders: Uncommon: Decreased appetite (0.7% vs 0%).
Psychiatric Disorders: Common: Depression* (5.4% vs 2%), hallucinations (1.3% vs 0.7%).
Nervous System Disorders: Very Common: Headache* (14.1% vs 11.9%). Uncommon: Cerebrovascular accident (0.7% vs 0%).
Eye Disorders: Common: Conjunctivitis* (2.7% vs 0.7%).
Ear and Labyrinth Disorders: Common: Vertigo (2.7% vs 1.3%).
Cardiac Disorders: Common: Angina pectoris (1.3% vs 0%). Uncommon: Myocardial infarction (0.7% vs 0%).
Respiratory, Thoracic and Mediastinal Disorders: Common: Rhinitis* (3.4% vs 0.7%).
Gastrointestinal Disorders: Common: Flatulence (1.3% vs 0%).
Skin and Subcutaneous Tissue Disorders: Common: Dermatitis* (2% vs 0%). Uncommon: Vesiculobullous rash (0.7% vs 0%).
Musculoskeletal and Connective Tissue Disorders: Common: Musculoskeletal pain* (6.7% vs 2.6%), neck pain* (2.7% vs 0%), arthritis (1.3% vs 0.7%).
Renal and Urinary Disorders: Common: Urinary urgency (1.3% vs 0.7%).
General Disorders and Administration Site Conditions: Common: Fever (2.7% vs 1.3%), malaise* (2% vs 0%).
*Adverse reactions with at least 2% difference over placebo.
Adjunct Therapy: The list as follows includes adverse reactions which were reported with a higher incidence in placebo-controlled studies in patients receiving rasagiline 1 mg/day (rasagiline group n=380, placebo group n=388).
Adverse reactions are ranked under headings of frequency using the following conventions: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000). In parentheses is the adverse reaction incidence (% of patients) in rasagiline versus placebo, respectively.
Benign, Malignant and Unspecified Neoplasms: Uncommon: Skin melanoma (0.5% vs 0.3%).
Metabolism and Nutrition Disorders: Common: Decreased appetite (2.4% vs 0.8%).
Psychiatric Disorders: Common: Hallucinations (2.9% vs 2.1%), abnormal dreams (2.1% vs 0.8%). Uncommon: Confusion (0.8% vs 0.5%).
Nervous System Disorders: Very Common: Dyskinesia* (10.5% vs 6.2%). Common: Dystonia (2.4% vs 0.8%), carpal tunnel syndrome (1.3% vs 0%), balance disorder (1.6% vs 0.3%). Uncommon: Cerebrovascular accident (0.5% vs 0.3%).
Cardiac Disorders: Uncommon: Angina pectoris (0.5% vs 0%).
Vascular Disorders: Common: Orthostatic hypotension* (3.9% vs 0.8%).
Gastrointestinal Disorders: Common: Abdominal pain* (4.2% vs 1.3%), constipation* (4.2% vs 2.1%), nausea and vomiting* (8.4% vs 6.2%), dry mouth (3.4% vs 1.8%).
Skin and Subcutaneous Tissue Disorders: Common: Rash (1.1% vs 0.3%).
Musculoskeletal and Connective Tissue Disorders: Common: Arthralgia (2.4% vs 2.1%), neck pain (1.3% vs 0.5%).
Investigations: Common: Decreased weight* (4.5% vs 1.5%).
Injury, Poisoning and Procedural Complications: Common: Fall (4.7% vs 3.4%).
*Adverse reactions with at least 2% difference over placebo.
Parkinson's disease is associated with symptoms of hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic, tetracyclic antidepressants and MAO inhibitors. In the post-marketing period, cases of serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants/SNRI concomitantly with rasagiline.
Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: Amitriptyline <50 mg daily, trazodone <100 mg daily, citalopram <20 mg daily, sertraline <100 mg daily and paroxetine <30 mg daily. There were no cases of serotonin syndrome in the rasagiline clinical program in which 115 patients were exposed concomitantly to rasagiline and tricyclics and 141 patients were exposed to rasagiline and SSRIs/SNRIs.
In the post-marketing period, cases of elevated blood pressure, including rare cases of hypertensive crisis associated with ingestion of unknown amounts of tyramine-rich foods, have been reported in patients taking rasagiline.
With MAO inhibitors there have been reports of drug interactions with the concomitant use of sympathomimetic medicinal products.
In post-marketing period, there was 1 case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in