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Zelapar

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Zelapar

Zelapar

Zelapar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zelapar (selegiline hydrochloride) is used together with other medicines to treat symptoms of Parkinson's disease. It is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin). Common side effects include dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache. Redness, pain, and swelling of the mouth/throat may also occur.

Treatment with Zelapar should be initiated with a 1.25 mg dose given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if prescribed. Zelapar may interact with arbamazepine, diet pills or cold medicines that contain ephedrine, pseudoephedrine, or phenylephrine, nafcillin, phenobarbital, rifampin, or antidepressants. Many other medicines can cause serious medical problems if taken together with Zelapar. Tell your doctor all medications and supplements you use. During pregnancy, Zelapar should be used only when prescribed. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Zelapar (selegiline hydrochloride) 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.

Zelapar 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 taking selegiline and call your doctor at once if you have any of these serious side effects:

  • sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);
  • feeling light-headed, fainting;
  • hallucinations;
  • feeling restless, agitated, or irritable;
  • twitching muscle movements; or
  • painful or difficult urination.

Less serious side effects may include:

  • dizziness, weakness;
  • sleep problems (insomnia);
  • runny or stuffy nose;
  • back pain;
  • constipation; or
  • mouth sores or ulcers, pain with swallowing (while using Zelapar).

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zelapar (Selegiline Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zelapar Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache may occur. Redness, pain, and swelling of the mouth/throat may also 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 selegiline. 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, difficulty urinating, unusual weight gain.

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 of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe 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 Zelapar (Selegiline Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zelapar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

A total of 578 patients received ZELAPAR® (selegiline hydrochloride) 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® (selegiline hydrochloride) treatment were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis, and dyspepsia.

Of the 194 patients treated with ZELAPAR® (selegiline hydrochloride) 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 Under Adverse Reactions

Table 1 lists the adverse events reported in the placebo-controlled trials after at least one dose of ZELAPAR® (selegiline hydrochloride) (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® (selegiline hydrochloride) and Numerically More Frequent than the Placebo Group)

Body System/
Adverse Event
ZELAPAR® (selegiline hydrochloride)
1.25/2.5 mg
N=194
%
Placebo
N=98
%
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
*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus patients may be included in more than one category.
** Skin disorders represent any new skin abnormality that would not be characterized as rash or neoplastic lesion.
Patients received concomitant levodopa.

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® (selegiline hydrochloride) % / Placebo%) for each treatment. The relative risk was ≥ 2 fold higher for ZELAPAR® (selegiline hydrochloride) treatment in the geriatric patients compared to the non-geriatric patients for hypertension, orthostatic/postural hypotension (See WARNINGS - orthostatic 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® (selegiline hydrochloride) 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 tests 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.

Postmarketing Reports

There have been reports of the following adverse reactions: pathological gambling, increased libido including hypersexuality, and impulse control symptoms while taking one or more of the medications that are generally used for the treatment of Parkinson's disease.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Read the entire FDA prescribing information for Zelapar (Selegiline Hydrochloride) »

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Zelapar - User Reviews

Zelapar 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 Zelapar 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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