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Azilect Side Effects

Generic Name: rasagiline

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

Not all side effects for Azilect may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to rasagiline: oral tablet

In addition to its needed effects, some unwanted effects may be caused by rasagiline (the active ingredient contained in Azilect). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking rasagiline:

Less common
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • black, tarry stools
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cloudy urine
  • cough
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • fever
  • hives, itching, or skin rash
  • loss of appetite
  • nausea
  • painful or difficult urination
  • persistent, non-healing sore
  • pink growth on the skin
  • puffiness or swelling of the eyelids or around the eyes
  • reddish patch or irritated area
  • redness, blistering, peeling, or loosening of the skin
  • seeing, hearing, or feeling things that are not there
  • shiny bump
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • sweating
  • swollen glands
  • tests that show problems with the liver
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness
  • white, yellow or waxy scar-like area

Some of the side effects that can occur with rasagiline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • headache
  • heartburn
  • indigestion
  • muscle pain or stiffness
  • pain in the joints
  • stomach discomfort or upset
Less common
  • Bruising
  • burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings
  • burning, dry, or itching eyes
  • decreased interest in sexual intercourse
  • difficulty breathing
  • difficulty with moving
  • discouragement
  • excessive tearing
  • eye discharge
  • fall
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • general feeling of discomfort or illness
  • hair loss
  • inability to have or keep an erection
  • irritability
  • joint pain
  • lack of appetite
  • large, flat, blue or purplish patches in the skin
  • lightheadedness
  • loss in sexual ability, desire, drive, or performance
  • loss of interest or pleasure
  • muscle aches
  • neck pain
  • noisy breathing
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • runny nose
  • sensation of spinning
  • shivering
  • sneezing
  • stuffy nose
  • swelling or redness in the joints
  • thinning of the hair
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to rasagiline: oral tablet

Cardiovascular

When used as an adjunct to levodopa, the risk for developing posttreatment high blood pressure, combined with a significant increase from baseline was higher for rasagiline (the active ingredient contained in Azilect) (2%) compared to placebo (1%).

Clinical trial data suggest that orthostatic hypotension occurs more frequently during the first 2 months of rasagiline treatment and tends to decrease over time.

Postmarketing reports of elevated blood pressure, including rare incidents of hypertensive crisis associated with the ingestion of unknown amounts of tyramine-rich foods, have been reported in patients taking recommended doses of rasagiline.[Ref]

Very common (10% or more): Orthostatic/postural hypotension
Common (1% to 10%): Angina pectoris, first degree AV block, hypertension, peripheral edema, peripheral vascular disorder
Uncommon (0.1% to 1%): Myocardial infarction
Postmarketing reports: Hypertensive crisis (after ingestion of unknown amounts of tyramine-rich foods)
Frequency not reported: Arrhythmia, blood pressure fluctuations, bradycardia, bundle branch block, cardiovascular disorder, complete AV block, heart arrest, pallor, palpitation, second degree AV block, thrombosis, vasodilatation, vascular disorder, ventricular arrhythmia, ventricular extrasystoles[Ref]

Nervous system

Very common (10% or more): Dizziness, dyskinesia, headache
Common (1% to 10%): Ataxia, balance disorder, carpal tunnel syndrome, dystonia, paresthesia
Uncommon (0.1% to 1%): Cerebrovascular accident, somnolence
Frequency not reported: Hyperkinesias, myoclonus, nystagmus, speech disorder, withdrawal-emergent hyperpyrexia and confusion resembling neuroleptic malignant syndrome
Postmarketing reports: Serotonin syndrome[Ref]

Dyskinesia or exacerbation of dyskinesia has been reported when rasagiline is used as an adjunct to levodopa. A dose reduction of levodopa may mitigate this effect.

Cases of patients treated with rasagiline and other dopaminergic medications falling asleep while engaged in activities of daily living including the operations of motor vehicles, have been reported and sometimes resulted in accidents. Some of these cases of somnolence have been reported more than 1 year after initiation of treatment.

The postmarketing reports of serotonin syndrome, associated with agitation, confusion, rigidity, pyrexia, and myoclonus have been reported by patients treated with antidepressants/SNRI concomitantly with rasagiline.

The symptom complex resembling neuroleptic malignant syndrome, with symptoms included elevated temperature, muscular rigidity, altered consciousness, and autonomic instability, has been reported with rapid dose reduction, and withdrawal of, or changes in, drugs that increase central dopaminergic tone.[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, depression, hallucinations, insomnia, sleep disorder
Uncommon (0.1% to 1%): Confusion
Frequency not reported: Paranoid reactions, personality disorder
Postmarketing reports: Impulse control disorders, new or worsening mental status and behavioral changes including psychotic-like behavior[Ref]

When studied as an adjunct to levodopa, the incidence of hallucinations was approximately 5% at a rasagiline dose of 0.5 mg per day, 4% at 1 mg per day, and 3% with placebo. Dose reduction or treatment discontinuation should be considered if hallucinations or psychotic-like behaviors develop.

Reduced impulse control or increased compulsive behaviors include intense urges to gamble, increased sexual urges, intense urges to spend money, and binge eating. Patients may not recognize these behaviors as abnormal. Dose reduction or treatment discontinuation should be considered if such urges develop.[Ref]

Other

Very common (10% or more): Accidental injury, fall
Common (1% to 10%): Fever, hernia, infection, malaise, otitis media, pain, sweating, vertigo
Frequency not reported: Chills, dysautonomia, prolonged immobilization[Ref]

Dermatologic

Common (1% to 10%): Alopecia, cellulitis, contact dermatitis, dermatitis, ecchymosis, rash
Uncommon (0.1% to 1%): Vesiculobullous rash
Frequency not reported: Abscesses, dry skin, gangrene, nail disorder, pruritus, psoriasis, skin ulcer, urticaria[Ref]

Oncologic

Common (1% to 10%): Benign skin neoplasm, melanoma, skin carcinoma
Frequency not reported: Bladder carcinoma, breast neoplasm, cyst, Kaposi's sarcoma[Ref]

Endocrine

Frequency not reported: Goiter, inappropriate antidiuretic hormone secretion[Ref]

Gastrointestinal

Very common (10% or more): Nausea
Common (1% to 10%): Abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, gingivitis, tooth disorder, vomiting
Frequency not reported: Colitis, dysphagia, eructation, esophagitis, fecal impaction, gastritis, gastrointestinal disorder, gastrointestinal hemorrhage, halitosis, intestinal obstruction, megacolon, mouth ulceration, periodontitis[Ref]

Genitourinary

Common (1% to 10%): Albuminuria, decreased libido, impotence, urinary urgency
Frequency not reported: Anuria, breast pain, dysmenorrhea, dysuria, nocturia, prostate-specific antigen increase, testis disorder, urogenital anomaly, vaginal hemorrhage[Ref]

Hematologic

Common (1% to 10%): Hemorrhage, leucopenia
Uncommon (0.1% to 1%): Anemia
Frequency not reported: Eosinophilia, leukocytosis, megaloblastic anemia, thrombocytopenia[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests[Ref]

Hypersensitivity

Common (1% to 10%): Allergy[Ref]

Immunologic

Common (1% to 10%): Flu syndrome, influenza, fungal infection
Frequency not reported: Sepsis, herpes simplex[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite, weight loss
Frequency not reported: Gout, hyperphosphatemia, hypokalemia, hypolipemia, increased lactic dehydrogenase, weight gain[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, arthritis, back pain, joint disorder, musculoskeletal pain, myasthenia, neck pain, tendon disorder, tenosynovitis
Frequency not reported: Bursitis, leg cramps, myositis, rhabdomyolysis following fall, spinal stenosis, tendinous contracture[Ref]

Ocular

Common (1% to 10%): Abnormal vision, conjunctivitis
Frequency not reported: Blindness, diplopia, eye disorder, eye hemorrhage, glaucoma, vitreous disorder[Ref]

Renal

Frequency not reported: Increased blood urea nitrogen, kidney pain[Ref]

Respiratory

Common (1% to 10%): Asthma, cough, dyspnea, pharyngitis, rhinitis, upper respiratory infection
Frequency not reported: Allergic rhinitis, epistaxis, pneumothorax, pulmonary embolus[Ref]

References

1. "Product Information. Azilect (rasagiline)." Teva Pharmaceuticals USA, North Wales, PA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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