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Azilect

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Azilect

Azilect Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Azilect (rasagiline)is used to treat the symptoms of Parkinson's disease. It is sometimes used with another drug called levodopa. Azilect is a monoamine oxidase-B (MAO-B) inhibitor. Common side effects include dizziness, joint pain, heartburn, nausea, fever, muscle pain, dry mouth, and stomach/abdominal pain.

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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Azilect in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Azilect Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, joint pain, heartburn, nausea, fever, muscle pain, dry mouth, and stomach/abdominal pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If you are also taking levodopa, you may experience more side effects from the levodopa when taking rasagiline. Tell your doctor immediately if any of these side effects occur: nausea, shakiness, muscle stiffness, mental/mood changes such as hallucinations/abnormal dreams. Your doctor may need to change your medication or dose. Do not stop or change the dose of your levodopa without talking with your doctor first.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, loss of balance, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, change in amount of urine, unusual weight gain/loss.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds.

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. (See also Drug Interactions section.) Seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (e.g., double/blurred vision), sudden sensitivity to light (photophobia).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Azilect (Rasagiline)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Azilect FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Azilect - User Reviews

Azilect User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Azilect sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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