Azilect Side Effects

Generic name: rasagiline

Note: This document contains side effect information about rasagiline. Some of the dosage forms listed on this page may not apply to the brand name Azilect.

Some side effects of Azilect may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rasagiline: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking rasagiline (the active ingredient contained in Azilect) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rasagiline and call your doctor at once if you have a serious side effect such as:

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);

• sudden numbness or weakness (especially on one side of the body), problems with speech or balance;

• unusual thoughts or behavior,

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• tremor, muscle twitching or stiffness; or

• feeling like you might pass out.

Less serious side effects of rasagiline may include:

• joint pain;

• mild headache, depressed mood;

• dizziness, spinning sensation;

• hair loss;

• mild skin rash;

• numbness or tingly feeling;

• dry mouth, loss of appetite;

• constipation, diarrhea, stomach pain or upset, vomiting, weight loss;

• impotence, loss of interest in sex, or trouble having an orgasm;

• strange dreams; or

• flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rasagiline: oral tablet

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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