Eldepryl Side Effects

Generic Name: selegiline

Please note - some side effects for Eldepryl may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Eldepryl - for the Consumer

Eldepryl

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eldepryl:

Dizziness; dry mouth; lightheadedness; nausea; stomach pain; vivid dreams.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; changes in sexual ability or desire; chest pain; confusion; dark or unusual growths on the skin or any skin changes; enlarged pupils; fast, slow, or irregular heartbeat; fever; hallucinations; increased sweating; memory loss; nausea; neck stiffness or soreness; new or worsening agitation, aggressiveness, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, or sleeplessness; rigid muscles; sensitivity to light; severe or persistent dizziness or headache; suicidal thought or actions; swelling of the arms or legs; tremor; unusual or intense urges (eg, gambling, sexual); vomiting.

Side Effects by Body System

Other

The most hazardous consequence of inhibition of MAO A is the potential for hypertensive crises. Such crises may be precipitated by ingestion of foods containing large amounts of exogenous amines (like tyramine) or concomitant use of medications containing indirect or mixed-acting sympathomimetic amines. At the usual therapeutic dose (10 mg per day), inhibition of MAO A generally does not occur and the manufacturer reports that patients may safely take selegiline without dietary restrictions. (For a list of foods which contain a large amount of tyramine, please see the "Interactions" section of this program). Patients should be instructed, however, to avoid over-the-counter cold remedies and other preparations which may contain vasoactive amines.

Selegiline is generally well tolerated. At the usual therapeutic dose (10 mg per day), selegiline provides selective inhibition of MAO B. At higher doses, loss of selectivity may occur and patients may be at risk of side effects related to inhibition of MAO A.

Gastrointestinal

Exacerbation of preexisting ulcer disease with severe upper gastrointestinal bleeding has been reported.

Gastrointestinal side effects have been reported the most frequently. These have included constipation, flatulence, anorexia, gastroenteritis, vomiting, increased appetite, thirst, periodontal abscess, eructation, gastritis, colitis, dysphagia, tongue edema, glossitis, increased salivation, melena, tongue disorder, tooth caries. Gastrointestinal neoplasia and rectal hemorrhage have also been reported rarely. Irritation of the buccal mucosa has been reported with the use of the orally disintegrating tablet.

Nervous system

Nervous system side effects have included agitation, paresthesia, thinking abnormal, amnesia, lag cramps, tremor, vertigo, hypertonia, twitching, emotional lability, confusion, manic reaction, depersonalization, hyperkinesias, hostility, myoclonus, circumoral paresthesia, hyperesthesia, increased libido, euphoria, neurosis, paranoid reaction. Ataxia has also been reported rarely. Data from postmarketing spontaneous reporting include a seizure in a dialyzed chronic renal failure patient. A clear causal relationship to selegiline was not established.

Patients taking levodopa-carbidopa may experience worsening of side effects attributable to levodopa. Dosage reduction of levodopa-carbidopa may be necessary.

Muscle twitch and myoclonic jerks have been reported at doses greater than 10 mg/day.

Psychiatric

Impaired memory, transient high, and increase energy have been reported at doses greater than 10 mg/day.

Psychiatric side effects have included hallucinations, confusion, anxiety, mania, hypomania, psychosis, depression, other mood changes, nightmares, and hypersexuality. Reversible transvestic fetishism has been reported in a 72-year-old man with Parkinson's disease after selegiline 5 mg oral twice daily was added to his therapy for motor fluctuations. After the selegiline was stopped, his urge to wear women's clothing stopped.

Cardiovascular

Cardiovascular side effects have included hypertension, vasodilation, tachycardia, migraine, syncope, atrial fibrillation, peripheral vascular disorder, and myocardial infarct.

Inhibition of MAO A may cause hypertensive crises if foods containing large amounts of exogenous amines (like tyramine) are consumed. Tyramine-rich foods and beverages should be avoided beginning on the first day of therapy with the transdermal system of selegiline 9 mg/24 hours or 12 mg/24 hours, and should continue to be avoided for two weeks after a dose reduction to 6 mg/24 hours or following the discontinuation of the 9 mg/24 hours or 12 mg/24 hours treatment. Patients receiving the higher doses should follow the recommended "Dietary Modifications Required for Patients Taking EMSAM 9 mg/24 hours and 12 mg/24 hours." If a hypertensive crisis occurs, the drug should be discontinued immediately and therapy to lower blood pressure should be instituted.

Other

Anticholinergic effects have been reported and include dry mouth, blurred vision, urinary retention and constipation.

Hepatic

Hepatic side effects have included transient and persistent abnormalities of liver function tests after chronic administration.

Some investigators have recommended baseline and annual measurements of liver function tests during selegiline therapy. Others have discounted the need for such monitoring.

Dermatologic

Dermatologic side effects have included pruritus, sweating, acne, dry skin, maculopapular rash, contact dermatitis, urticaria, herpes simplex, alopecia, vesiculobullous rash, herpes zoster, skin hypertrophy, fungal dermatitis, and skin benign neoplasm. Eczema has also been reported rarely.

Genitourinary

Genitourinary side effects have included urinary tract infection, urinary frequency, dysmenorrhea, metrorrhagia, vaginitis, cystitis (female), hematuria (female), unintended pregnancy, dysuria (female), urinary urgency (male and female), vaginal moniliasis, menorrhagia, urination impaired (male), breast neoplasm (female), kidney calculus (female), vaginal hemorrhage, amenorrhea, breast pain and polyuria (female).

Ocular

Ocular side effects have included diplopia and blurred vision.

Respiratory

Respiratory side effects have bronchitis, increased cough, dyspnea, asthma, pneumonia, and laryngismus. Epistaxis, laryngitis, and yawn have also been reported rarely.

Local

Most of the application site reactions were described as erythema and most resolved spontaneously, requiring no treatment.

Local side effects have included application site reaction. It was the adverse event associated with discontinuation of the transdermal system.

Hematologic

Hematologic side effects have included ecchymosis, anemia, and lymphadenopathy. Leukocytosis, leukopenia, and petechiae have also been reported rarely.

Musculoskeletal

Musculoskeletal side effects have included myalgia, pathological fracture, arthralgia, generalized spasm, arthritis, myasthenia, arthrosis, and tenosynovitis. Osteoporosis has also been reported rarely.

Metabolic

Metabolic side effects have included peripheral edema, hyperglycemia, increased SGPT, hypercholesterolemia, increased SGOT, dehydration, alcohol intolerance, hyponatremia, and increased lactic dehydrogenase. Hypoglycemic reactions, bilirubinemia, and increased alkaline phosphatase have also been reported rarely.

General

General side effects have included neck pain, chest pain, bacterial infections, fever, cyst, fungal infection, chills, viral infection, suicide attempt, neck rigidity, pelvic pain, photosensitivity reaction, face edema, flank pain, hernia, intentional injury, neoplasm, generalized edema, and overdose. Body odor, halitosis, heat stroke, parasitic infection, malaise, and moniliasis have also been reported rarely.

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