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Azilect

  • Generic Name: rasagiline
  • Brand Name: Azilect

Azilect (Rasagiline) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Azilect Side Effects Center

What Is Azilect?

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.

What Are Side Effects of Azilect?

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.

Dosage for Azilect?

The recommended dose of Azilect for the treatment of Parkinson's disease patients is 1 mg administered orally once daily.

What Drugs, Substances, or Supplements Interact with Azilect?

Azilect may interact with ciprofloxacin, theophylline, or antidepressants. Other drugs may affect Azilect. Tell your doctor all medications you use.

Azilect During Pregnancy and Breastfeeding

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.

Additional Information

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

 

Azilect Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe headache, blurred vision, pounding in your neck or ears;
  • extreme drowsiness or falling asleep suddenly, even after feeling alert;
  • unusual changes in mood or behavior;
  • hallucinations;
  • a light-headed feeling, like you might pass out; or
  • worsening symptoms of Parkinson's disease (especially uncontrolled muscle movements).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Some people taking rasagiline with levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • depressed mood;
  • sleep problems (insomnia), strange dreams;
  • involuntary muscle movements;
  • loss of appetite, weight loss;
  • indigestion, stomach pain, nausea, vomiting, constipation;
  • joint pain or stiffness;
  • rash;
  • cough or other flu symptoms;
  • dry mouth; or
  • swelling in your hands or feet.

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:

  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
  • Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
  • Hypotension / Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Hallucinations / Psychotic-Like Behavior [see WARNINGS AND PRECAUTIONS]
  • Impulse Control /Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]

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)
% of Patients		Placebo
(N=151)
% of Patients
Headache1412
Arthralgia74
Dyspepsia74
Depression52
Fall53
Flu syndrome51
Conjunctivitis31
Fever31
Gastroenteritis31
Rhinitis31
Arthritis21
Ecchymosis20
Malaise20
Neck Pain20
Paresthesia21
Vertigo21
*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)
% of Patients		Placebo
(N=164)
% of Patients
Dizziness76
Peripheral edema74
Headache64
Nausea64
Fall61
Arthralgia52
Back pain43
Cough41
Insomnia41
Upper respiratory tract infection42
Orthostatic hypotension31
*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)
% of Patients		AZILECT 0.5 mg
(N=164)
% of Patients		Placebo
(N=159)
% of Patients
Dyskinesia181810
Accidental injury1285
Nausea12108
Headache11810
Fall11128
Weight loss923
Constipation945
Postural hypotension963
Arthralgia864
Vomiting741
Dry mouth623
Rash633
Somnolence644
Abdominal pain521
Anorexia521
Diarrhea574
Ecchymosis523
Dyspepsia544
Paresthesia523
Abnormal dreams411
Hallucinations453
Ataxia361
Dyspnea352
Infection322
Neck pain311
Sweating321
Tenosynovitis310
Dystonia321
Gingivitis211
Hemorrhage211
Hernia211
Myasthenia221
*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.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AZILECT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders: Melanoma

Read the entire FDA prescribing information for Azilect (Rasagiline)

&Copy; 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.