Overall, 1361 patients participated in the rasagiline clinical trial program, which was 3,076.4 patient-years. In double-blind, placebo-controlled trials, 529 patients rasagiline at a dose of 1 mg / day, which was 212 patient-years, and 539 patients received placebo, which was 213 patient-years.
Monotherapy
The following list describes unwanted reactions reported with an increased incidence in placebo-controlled studies in patients who received 1 mg / day rasagiline (rasagiline group-n = 149, placebo-p = 151 group).
Undesirable reactions with differences greater than 2% compared with the placebo group were isolated italics.
The frequency of adverse reactions (% of patients) is indicated in parentheses: rasagiline / placebo. Undesired reactions are distributed according to the following frequency: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1/10000 up to <1/1000), very rarely (<1/10000).
Infectious and parasitic diseases: often - the flu (4.7% / 0.7%). Benign, malignant and unspecified neoplasms (including cysts and polyps): often - skin cancer (1.3% / 0.7%).
From the side of the blood and lymphatic system: often - leukopenia (1.3% / 0%).
From the immune system: often - allergy (1.3% / 0.7%).
From the side of metabolism and nutrition: infrequently, a decrease in appetite (0.7% / 0%).
From the side of the psyche: often - depression (5.4% / 2%), hallucinations (1.3% / 0.7%).
From the nervous system: very often - headache (4.1% / 11.9%); infrequently - impaired cerebral circulation (0.7% / 0%).
From the side of the organ of vision: often -
conjunctivitis (2.7% / 0.7%).
From the side of the hearing organ and labyrinthine disorders: often - vertigo (2.7% / 1.3%).
From the heart: often - angina (1.3% / 0%); infrequently, myocardial infarction (0.7% / 0%).
From the gastrointestinal tract: bloating (1.3% / 0%).
On the part of the respiratory system: often - rhinitis (3.4% / 0.7%).
From the skin and subcutaneous tissues: often - dermatitis (2.0% / 0%); infrequently, a vesiculo-bullous rash (0.7% / 0%).
From the musculoskeletal system and connective tissue: often - musculoskeletal pain (6.7% / 2.6%), neck pain (2.7% / 0%), arthritis (1.3% / 0.7%).
From the side of the kidneys and urinary tract: often - the urge to urinate (1.3% / 0.7%).
General violations and violations at the place of introduction:
Often - fever (2.7% / 1.3%), malaise
(2% o / 0%).
When used as placebo-controlled trials in patients receiving 1 mg / day rasagiline (group controlled studies in patients who received 1 mg / day rasagiline (rasagiline group - n = 380, placebo group - n = 388). The frequency of adverse reactions (% of patients) is indicated in parentheses: rasagiline / placebo.
Undesirable reactions with differences greater than 2% compared with the placebo group were isolated italics.
The frequency of adverse reactions (% of patients) is indicated in parentheses: rasagiline / placebo. Undesired reactions are distributed according to the following frequency: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1/10000 up to <1/1000), very rarely (<1/10000).
Benign, malignant and unspecified neoplasms (including cysts and polyps):
infrequently, melanoma of the skin (0.5% / 0.3%).
From the side of metabolism and nutrition: often - a decrease in appetite (2.4% / 0.8%).
From the side of the psyche:
often - hallucinations (2.9% / 2.1%), nightmarish dreams (2.1% / 0.8%). infrequently - confusion (0.8% / 0.5%).
From the nervous system:
Often - dyskinesia (10.5% / 6.2%).
often - dystonia (2.4% / 0.8%), the syndrome
carpal tunnel (1.3% / 0%), violation
equilibrium (1.6% / 0.3%).
infrequently - a disorder of the brain
blood circulation (0.5% / 0.3%).
From the heart:
infrequently - angina (0.5% / 0%).
From the side of the vessels:
often - orthostatic hypotension (3,9%/ 0,8%).
From the digestive system: often - abdominal pain (4,2%>/ 1,3%), constipation (4,2%/ 2,1%>), nausea and vomiting (8.4%> / 6.2% o), dry mouth (3.4% / 1.8%).
From the skin and subcutaneous tissues: often - a rash (1.1% / 0.3%).
From the side of the musculoskeletal and connective tissue:
According to the post-experience experience, these symptoms were noted in patients with Parkinson's disease,
who received rasagiline.
About serious undesirable reactions arising at simultaneous these symptoms were noted in patients with Parkinson's disease,
who received rasagiline.
About serious undesirable reactions arising at simultaneous
application of SSRIs, SSRIs,
tricyclic / tetracyclic antidepressants and MAO inhibitors are well known.In the post-marketing period, cases of the development of serotonin syndrome, manifested in agitation, confusion,
rigidity, fever, and myoclonus, in patients concomitantly taking antidepressants / SSRIs and rasagiline.
In clinical studies of rasagiline, the simultaneous use of it with fluoxetine or fluvoxamine was not allowed. However, the following antidepressants were allowed in these doses: amitriptyline not more than 50 mg / day, trazodone not more than 100 mg / day, citalopram not more than 20 mg / day, sertraline not more than 100 mg / day and paroxetine not more than 30 mg / day. In a clinical research program in which rasagiline simultaneously applied with tricyclic
antidepressants (115 patients) and SSRIs / SSRIs (141 patients), cases of serotonin syndrome were not observed. When rasagiline was used during the postgistribution period, it was reported that blood pressure (BP) increased, including rare cases of hypertensive crises, in patients using an undefined diet in the diet
number of products rich in tyramine. There are cases of drug
interaction with the simultaneous use of MAO inhibitors with sympathomimetic drug preparations.