Slideshows Images Quizzes

Azilect

Last reviewed on RxList: 1/30/2017
Azilect Side Effects Center

Last reviewed on RxList 11/30/2016

Azilect (rasagiline) is a monoamine oxidase-B (MAO-B) inhibitor used to treat the symptoms of Parkinson's disease. Azilect is sometimes used with another drug called levodopa. Common side effects of Azilect include:

If you are also taking levodopa, you may experience more side effects from the levodopa when taking Azilect. Tell your doctor if any of these side effects occur:

  • nausea,
  • shakiness,
  • muscle stiffness,
  • mental/mood changes such as hallucinations/abnormal dreams.

The recommended dose of Azilect for the treatment of Parkinson's disease patients is 1 mg administered orally once daily. Azilect may interact with ciprofloxacin, theophylline, or antidepressants. Other drugs may affect Azilect. Tell your doctor all medications you use. During pregnancy, Azilect should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Azilect (rasagiline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Azilect Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azilect (Rasagiline)

Azilect Professional Information

SIDE EFFECTS

The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

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 the incidence of adverse reactions in the clinical trials of another drug and may not reflect the rates of adverse reactions observed in practice.

During the clinical development of AZILECT, Parkinson's disease patients received AZILECT as initial monotherapy (Study 1) and as adjunct therapy (Study 2, Study 3, Study 4). As the populations in these studies differ, not only in the adjunct use of dopamine agonists or levodopa during AZILECT treatment, but also in the severity and duration of their disease, the adverse reactions are presented separately for each study.

Monotherapy Use of AZILECT

In Study 1, approximately 5% of the 149 patients treated with AZILECT 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.

The most commonly observed adverse reactions in Study 1 (incidence in AZILECT-treated patients 3% or greater than the incidence in placebo-treated patients) included flu syndrome, arthralgia, depression, and dyspepsia. Table 1 lists adverse reactions that occurred in 2% or greater of patients receiving AZILECT as monotherapy and were numerically more frequent than in the placebo group in Study 1.

Table 1: Adverse Reactions* in Study 1

  AZILECT 1 mg
(N=149)
Placebo
(N=151)
% of Patients % of Patients
Headache 14 12
Arthralgia 7 4
Dyspepsia 7 4
Depression 5 2
  AZILECT 1 mg (N=149) Placebo (N=151)
  % of Patients % of Patients
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
*Incidence 2% or greater in AZILECT 1 mg group and numerically more frequent than in placebo group

There were no significant differences in the safety profile based on age or gender.

Adjunct Use of AZILECT

AZILECT was studied as an adjunct therapy without levodopa (Study 2), or as an adjunct therapy to levodopa, with some patients also taking dopamine agonists, COMT inhibitors, anticholinergics, or amantadine (Study 3 and Study 4).

In Study 2, approximately 8% of the 162 patients treated with AZILECT discontinued treatment due to adverse reactions compared to 4% of the 164 patients who received placebo.

Adverse reactions that led to the discontinuation of more than one patient were nausea and dizziness.

The most commonly observed adverse reactions in Study 2 (incidence in AZILECT-treated patients 3% or greater than incidence in placebo-treated patients) included peripheral edema, fall, arthralgia, cough, and insomnia. Table 2 lists adverse reactions that occurred in 2% or greater in patients receiving AZILECT as adjunct therapy without levodopa and numerically more frequent than in the placebo group in Study 2.

Table 2: Adverse Reactions* in Study 2

  AZILECT 1 mg
(N=162)
Placebo
(N=164)
% of Patients % of Patients
Dizziness 7 6
Peripheral edema 7 4
Headache 6 4
Nausea 6 4
Fall 6 1
Arthralgia 5 2
Back pain 4 3
Cough 4 1
Insomnia 4 1
Upper respiratory tract infection 4 2
Orthostatic hypotension 3 1
*Incidence 2% or greater in AZILECT 1 mg group and numerically more frequent than in placebo group

There were no significant differences in the safety profile based on age or gender.

In Study 3, adverse event reporting was considered more reliable than Study 4; therefore, only the adverse event data from Study 3 are presented below.

In Study 3, 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 AZILECT-treated patient were diarrhea, weight loss, hallucination, and rash.

The most commonly observed adverse reactions in Study 3 (incidence in AZILECT-treated patients 3% or greater than the incidence in placebo-treated patients) included dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall and tenosynovitis.

Table 3 lists adverse reactions that occurred in 2% or greater of patients treated with AZILECT 1 mg/day and that were numerically more frequent than the placebo group in Study 3.

Table 3: Adverse Reactions* in Study 3

  AZILECT 1 mg
(N=149)
AZILECT 0.5 mg
(N=164)
Placebo
(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
  AZILECT 1 mg (N=149) AZILECT 0.5 mg (N=164) Placebo
(N=159)
  % of patients % of patients % of patients
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
*Incidence 2% or greater in AZILECT 1 mg group and numerically more frequent than in placebo group Several of the more common adverse reactions seemed dose-related, including weight loss, postural hypotension, and dry mouth. There were no significant differences in the safety profile based on age or gender. During all Parkinson's disease phase 2/3 clinical trials, the long-term safety profile was similar to that observed with shorter duration exposure.

Read the entire FDA prescribing information for Azilect (Rasagiline)

Related Resources for Azilect

Read the Azilect User Reviews »

© Azilect Patient Information is supplied by Cerner Multum, Inc. and Azilect Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors