Rasagiline Side Effects
Applies to rasagiline: oral tablet.
Precautions
It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Do not use this medicine if you are using St. John's wort, cyclobenzaprine, dextromethorphan, meperidine, methadone, propoxyphene, tramadol, or used a MAO inhibitor within the past 14 days.
If you experience signs and symptoms of high blood pressure, you should seek immediate medical attention. Signs and symptoms include severe headache, blurred vision or visual disturbances, difficulty thinking, stupor or coma, seizures, chest pain, unexplained nausea or vomiting.
Make sure your doctor knows about all the other medicines you are using. Rasagiline may cause a serious condition called serotonin syndrome when used with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.
This medicine may make you dizzy or drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.
If you are taking this medicine with levodopa, you may experience increased dyskinesia (eg, twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs). Check with your doctor if you have any of these symptoms.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.
If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.
Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
Do not stop taking rasagiline without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.
It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.
Common side effects of rasagiline
Some side effects of rasagiline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- 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 side effects
- 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
Serious side effects of rasagiline
Along with its needed effects, rasagiline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking rasagiline:
Less common side effects
- 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
For healthcare professionals
Applies to rasagiline: oral tablet.
Cardiovascular adverse events
- 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]
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 (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]
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]
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References
1. (2006) "Product Information. Azilect (rasagiline)." Teva Pharmaceuticals USA
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Rasagiline side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.