Zelapar Side Effects

Generic Name: selegiline

Please note - some side effects for Zelapar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Zelapar - for the Consumer

Zelapar Orally Disintegrating Tablets

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 Zelapar Orally Disintegrating Tablets:

Back pain; constipation; dizziness; drowsiness; dry mouth; headache; mild sores, pain, or irritation in the mouth; nausea; runny or stuffy nose; sore throat; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Zelapar Orally Disintegrating Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior or mood changes (eg, depression); change in the amount of urine produced; chest pain; confusion; dark growths on the skin; fainting; fast or irregular heartbeat; fever; hallucinations; increased sweating; memory loss; neck or muscle stiffness or soreness; pain when swallowing; severe or persistent dizziness or drowsiness; severe or persistent headache or nausea; swelling of the arms or legs; unusual or intense urges (eg, gambling, sexual urges); unusual muscle movements or loss of muscle control; unusual weakness or fatigue; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Zelapar Side Effects - for the Professional

Zelapar

A total of 578 patients received Zelapar® in clinical trials. Because the controlled trials performed during premarketing development both used a titration design (1.25 mg per day for 6 weeks, followed by 2.5 mg per day for 6 weeks), with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse events.

The most commonly observed adverse events, which were greater than placebo, reported in the double-blind, placebo-controlled trials during Zelapar® treatment were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis, and dyspepsia.

Of the 194 patients treated with Zelapar® in the double-blind, placebo-controlled trials, 5.2% discontinued due to adverse events compared to 1.0% of the 98 patients who received placebo. Events causing discontinuation of treatment included dizziness, chest pain, accidental injury, and myasthenia.

INCIDENCE IN CONTROLLED CLINICAL TRIALS

Table 1 lists the adverse events reported in the placebo-controlled trials after at least one dose of Zelapar® (incidence ≥ 2%). The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients may differ.

Table 1

Treatment- Emergent Adverse Events* Incidence in Double-Blind, Placebo- Controlled Trials (Events ≥ 2% of Patients Treated with Zelapar® and Numerically More Frequent than the Placebo Group)
Body System/Adverse Event	Zelapar®† 1.25/2.5 mg N=194 %	Placebo † N=98 %
* Patients may have reported multiple adverse experiences during the study or at discontinuation; thus patients may be included in more than one category. † Patients received concomitant levodopa. ‡ Skin disorders represent any new skin abnormality that would not be characterized as rash or neoplastic lesion.
Body as a Whole
Back Pain	5	3
Chest Pain	2	0
Pain	8	7
Cardiovascular System
Hypertension	3	2
Digestive System
Constipation	4	0
Diarrhea	2	1
Dysphagia	2	1
Dyspepsia	5	3
Flatulence	2	1
Nausea	11	9
Stomatitis	5	4
Tooth Disorder	2	1
Vomiting	3	0
Hemic and Lymphatic System
Ecchymosis	2	0
Metabolic and Nutritional Disorders
Hypokalemia	2	0
Musculoskeletal System
Leg Cramps	3	1
Myalgia	3	0
Nervous System
Ataxia	3	1
Depression	2	1
Dizziness	11	8
Dry Mouth	4	2
Dyskinesia	6	3
Hallucinations	4	2
Headache	7	6
Insomnia	7	4
Somnolence	3	2
Tremor	3	1
Respiratory System
Dyspnea	3	0
Pharyngitis	4	2
Rhinitis	7	6
Skin and Appendages
Rash	4	1
Skin Disorders‡	6	2

Treatment emergent adverse events were reported at a higher frequency by patients ≥ 65 years of age compared to patients <65 years old. Analysis of adverse event incidence in each group was conducted to calculate and compare relative risk Zelapar® % / Placebo%) for each treatment. The relative risk was ≥ 2 fold higher for Zelapar® treatment in the geriatric patients compared to the non-geriatric patients for hypertension, orthostatic/postural hypotension, dizziness, somnolence, ECG abnormality, nausea, dyspepsia, abnormal dreams, anxiety, cheilitis, diarrhea, hyperkalemia, pharyngitis, flu syndrome, and infection.

No consistent differences in the incidences of adverse events were observed between male and female patients.

There were insufficient data to assess the impact of race on the incidence of adverse events.

Other Adverse Events Observed During all Clinical Trials

Zelapar® has been administered to 578 patients for whom complete adverse event data was captured during all clinical trials, only some of which were placebo controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. Similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. All reported events are included below except those already listed elsewhere in labeling, those too general to be informative, and those not reasonably associated with the use of the drug.

Body as a Whole: allergic reaction, cellulitis, cyst, face edema, fever, hernia, infection fungal, infection superimposed, infection viral, neck pain, neoplasm, pain flank, cyanosis.

Nervous System: abnormal gait, agitation, akinesia, aphasia, CNS neoplasia, dementia, dystonia, emotional lability, encephalopathy, hyperkinesias, hypertonia, hypokinesia, hypotonia, incoordination, increased salivation, myclonus, nervousness, neuralgia, neuropathy, paranoid reaction, paresthesia, peripheral neuritis, personality disorder, psychosis, reflexes decreased, sleep disorder, subdural hematoma, thinking abnormal, vertigo, migraine.

Digestive System: anorexia, cholecystitis, cholelithiasis, colitis, esophageal ulcer, esophagitis, gamma glutamyl transpeptidase increased, gastritis, gastroenteritis, gingivitis, hepatitis, intestinal obstruction, liver function test abnormal, peptic ulcer, tongue edema.

Cardiovascular System: angina pectoris, atrial fibrillation, atrial flutter, AV block first degree, bigeminy, cardiomegaly, cardiomyopathy, cerebral ischemia, congestive heart failure, heart arrest, hypotension, migraine, myocardial infarct, myocardial ischemia, pallor, sinus bradycardia, supraventricular tachycardia, syncope, vascular disorder, vasodilation.

Musculoskeletal System: arthralgia, arthritis, arthrosis, bone pain, bursitis, leg cramps, tendon rupture, tenosynovitis.

Respiratory System: sinusitis, asthma, bronchitis, carcinoma of the lung, hiccup, epistaxis, lung edema, pleural effusion, pneumonia, pneumothorax, voice alteration.

Skin and Appendages: contact dermatitis, dry skin, eczema, fungal dermatitis, herpes simplex, herpes zoster, pruritis, seborrhea, skin benign neoplasm, skin carcinoma, skin hypertrophy, skin melanoma, skin discoloration, skin ulcer, sweating.

Metabolic and Nutritional Disorders: avitaminosis, dehydration, diabetes mellitus, edema, gout, hyperchloestermia, hyperglycemia, hyperkalemia, hyperlipidemia, hyperphosphatemia, hypoglycemia, albuminuria, hyponatremia, hypoproteinemia, SPGT increased.

Urogenital Disorders: breast carcinoma, cystitis, epididymitis, kidney calculus, ovarian disorder, prostatic carcinoma, prostatic specific antigen increase, urinary frequency, urination impaired, urinary incontinence, urinary urgency.

Special Senses: abnormal vision, amblyopia, blindness, cataract specified, conjunctivitis, deafness, diplopia, dry eyes, eye hemorrhage, glaucoma, otitis externa, retinal artery occlusion, retinal detachment, taste loss, taste perversion, tinnitus.

Hemic and Lymphatic System: abnormal platelets, anemia, chronic leukocytosis, cyanosis, eosinophilia, lymphoma like reaction, myelocytic leukemia, sedimentation rate increased.

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Side Effects by Body System - for Healthcare Professionals

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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