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Azilect

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Azilect

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

Clinical Studies Experience

During the clinical development of AZILECT, 1361 Parkinson's disease patients received rasagiline as initial monotherapy or as adjunct therapy to levodopa. As these two populations differ, not only in the adjunct use of levodopa during rasagiline treatment, but also in the severity and duration of their disease, they may have differential risks for various adverse reactions. Therefore, most of the adverse reactions data in this section are presented separately for each population.

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

Patients Receiving AZILECT (rasagiline) as Initial Monotherapy Treatment

Adverse Reactions Leading to Discontinuation in Controlled Clinical Studies

In the double-blind, placebo-controlled trials con ducted in patients receiving AZILECT (rasagiline) as monotherapy, approximately 5% of the 149 patients treated with rasagiline 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.

Adverse Reaction Incidence in Controlled Clinical Studies

The most commonly observed adverse reactions were those in which the treatment difference for the incidence in AZILECT (rasagiline) -treated patients was ≥ 3 % greater than the incidence in the placebo-treated patients and included flu syndrome, arthralgia, depression, and dyspepsia. Table 1 lists treatment-emergent adverse reactions that occurred in ≥ 2% of patients receiving AZILECT (rasagiline) as monotherapy participating in the double -blind, placebo-controlled trial and were numerically more frequent than in the placebo group.

Table 1 :Treatment-Emergent* Adverse Reactions in AZILECT (rasagiline) 1 mg-Treated Monotherapy Patients

Placebo-Controlled Studies Without Levodopa Treatment AZILECT (rasagiline) 1 mg
(N=149)
% of Patients
Placebo
(N=151)
% of Patients
Headache 14 12
Arthralgia 7 4
Dyspepsia 7 4
Depression 5 2
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% in AZILECT 1 mg group and numerically more frequent than in placebo group

Other events of potential clinical importance reported by 1% or more of patients receiving AZILECT (rasagiline) as monotherapy, and at least as frequent as in the placebo group, in descending order of frequency include: dizziness, diarrhea, chest pain, albuminuria, allergic reaction, alopecia, angina pectoris, anorexia, asthma, hallucinations, impotence, leukopenia, libido decreased, liver function tests abnormal, skin carcinoma, syncope, vesiculobullous rash, vomiting.

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

Patients Receiving AZILECT (rasagiline) as Adjunct to Levodopa Therapy

Adverse Reactions Leading to Discontinuation in Controlled Clinical Studies

In a double-blind, placebo-controlled trial (Study 1) conducted in patients treated with AZ ILECT as adjunct to levodopa therapy, approximately 9% of the 164 patients treated with AZILECT (rasagiline) 0.5 mg /day and 7% of the 149 patients treated with AZILECT (rasagiline) 1 mg/day discontinued treatment due to adverse react ions compared to 6% of the 159 patients who received placebo. The adverse reactions that led to discontinuation of more than one rasagiline-treated patient were: diarrhea, weight loss, hallucination, and rash. Adverse event reporting was considered more reliable for Study 1 than for the second controlled trial (Study 2); therefore only the adverse event data from Study 1 are presented in this section of labeling.

Adverse Reactions: Incidence in Controlled Clinical Studies

The most commonly observed adverse reactions were those in which the treatment difference for the incidence in AZILECT (rasagiline) -treated patients (n=149) was ≥ 3 % greater than the incidence in the placebo-treated patients (n=159) and included dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.

Table 2 lists treatment-emergent adverse reactions that occurred in ≥ 2% of patients treated with AZILECT (rasagiline) 1 mg/day as adjunct to levodopa therapy participating in the double-blind, placebo-controlled trial (Study 1) and that were numerically more frequent than t he placebo group. The table also shows the rates for the 0.5 mg group in Study 1 .

Table 2: Incidence of Treatment-Emergent* Adverse Reactions in Patients Receiving AZILECT (rasagiline) as Adjunct to Levodopa Therapy in Study 1

  AZILECT (rasagiline)
1 mg + Levodopa
(N=149)
% of patients
AZILECT (rasagiline)
0.5 mg + Levodopa
(N=164)
% of patient
Placebo
+ Levodopa
(N=159)
% 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
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% 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.

Other adverse reactions s of potential clinical importance reported in Study 1 by 1% or more of patients treated with rasagiline 1 mg/day as adjunct to levodopa therapy, and at least as frequent as in the placebo group, in descending order of frequency include : skin carcinoma, anemia, albuminuria, amnesia, arthritis, bursitis, cerebrovascular accident, confusion, dysphagia, epistaxis, leg cramps, pruritus, skin ulcer.

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

Other Adverse Reactions Observed During All Phase 2/3 Clinical Trials

Rasagiline was administered to approximately 1361 patients during all PD phase 2/3 clinical trials. About 283 patients received rasagiline for at least one year, approximately 410 patients received rasagiline for at least two years, 116 patients received rasagiline for at least 3 years, and 245 patients received rasagiline for more than 3 years, with some patients treated for more than 5 years. The long-term safety profile was similar to that observed with shorter duration exposure.

The frequencies listed below represent the proportion of the 1361 individuals exposed to rasagiline who experienced events of the type cited.

All events that occurred at least twice (or once for serious or potentially serious events), except those already listed above, trivial events, terms too vague to be meaningful, adverse events with no plausible relation to treatment, and events that would be expected in patients of the age studied, w ere reported without regard to determination of a causal relationship to rasagiline.

Events are further classified within body system categories and enumerated in order of decreasing frequency using t he following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are defined as those occurring in at least 1/100 to 1/1000 patients and rare adverse events are defined as those occurring in fewer than 1/1000 patients.

Body as a whole: Frequent: asthenia Infrequent: chills, face edema, flank pain, photosensitivity reaction

Cardiovascular system: Frequent: bundle branch block Infrequent: deep thrombophlebitis, heart failure, migraine, myocardial infarct, phlebitis, ventricular tachycardia Rare: arterial thrombosis, atrial arrhythmia, AV block complete, AV block second degree, bigeminy, cerebral hemorrhage, cerebral ischemia, ventricular fibrillation

Digestive system: Frequent: gastrointestinal hemorrhage Infrequent: colitis, esophageal ulcer, esophagitis, fecal incontinence, intestinal obstruction, mouth ulceration, stomach ulcer, stomatitis, tongue edema Rare: hematemesis, hemorrhagic gastritis, intestinal perforation, intestinal stenosis, jaundice, large intestine perforation, megacolon, melena

Hemic and Lymphatic system: Infrequent: macrocytic anemia Rare: purpura, thrombocythemia

Metabolic and Nutritional disorders: Infrequent: hypocalcemia

Musculoskeletal system: Infrequent: bone necrosis, muscle atrophy Rare: arthrosis

Nervous system: Frequent: abnormal gait, anxiety, hyperkinesia, hypertonia, neuropathy, tremor Infrequent: 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, wrist drop Rare: apathy, delirium, hostility, manic depressive reaction, myelitis, neuralgia, psychotic depression, stupor

Respiratory system: Frequent: cough increased Infrequent: apnea, emphysema, laryngismus, pleural effusion, pneumothorax Rare: interstitial pneumonia, larynx edema, lung fibrosis

Skin and Appendages: Infrequent: eczema, urticaria Rare: exfoliative dermatitis, leukoderma

Special senses: Infrequent: blepharitis, deafness, diplopia, eye hemorrhage, eye pain, glaucoma, keratitis, ptosis, retinal degeneration, taste perversion, visual field defect Rare: blindness, parosmia, photophobia, retinal detachment, retinal hemorrhage, strabismus, taste loss, vestibular disorder

Urogenital system: Frequent: hematuria, urinary incontinence Infrequent: acute kidney failure, dysmenorrhea, dysuria, kidney calculus, nocturia, polyuria, scrotal edema, sexual function abnormal, urinary retention, urination impaired, vaginal hemorrhage, vaginal moniliasis, vaginitis Rare: abnormal ejaculation, amenorrhea, anuria, epididymitis, gynecomastia, hydroureter, leukorrhea, priapism

Post-marketing Experience

The following adverse events not described in sections 4 and 5 have been identified during the postmarketing/post-approval use of AZILECT (rasagiline) . Because these adverse events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency nor to establish unequivocally a causal relationship to drug exposure: Increased libido including hypersexuality, impulse control symptoms, pathological gambling [see PATIENT INFORMATION]

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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