Note: This document contains side effect information about selegiline. Some dosage forms listed on this page may not apply to the brand name Emsam.

Summary

Common side effects of Emsam include: application site reaction and insomnia. Other side effects include: skin rash, weight loss, and orthostatic hypotension. Continue reading for a comprehensive list of adverse effects.

Applies to selegiline: oral capsule, oral tablet, oral tablet disintegrating. Other dosage forms:

• transdermal patch extended release

Serious side effects of Emsam

Along with its needed effects, selegiline (the active ingredient contained in Emsam) 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 selegiline:

More common

• Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Less common

• Blurred vision
• bruising
• chest pain or tightness
• decreased urine
• difficult or labored breathing
• difficulty with swallowing
• discouragement
• dizziness
• dry mouth
• feeling sad or empty
• headache
• increased thirst
• irregular heartbeat
• irritability
• large, flat, blue or purplish patches in the skin
• loss of appetite
• loss of interest or pleasure
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• slow or fast heartbeat
• swelling or inflammation of the mouth
• tiredness
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

Incidence not known

• Agitation
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• overactive reflexes
• poor coordination
• restlessness
• shivering
• sweating
• talking or acting with excitement you cannot control

Get emergency help immediately if any of the following symptoms of overdose occur while taking selegiline:

Symptoms of overdose

• Agitation
• chest pain
• difficulty opening the mouth or lockjaw
• dizziness (severe) or fainting
• fast or irregular pulse (continuing)
• high fever
• high or low blood pressure
• severe spasm where the head and heels are bent backward and the body arched forward
• trouble breathing

Other side effects of Emsam

Some side effects of selegiline 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

• Dry skin
• hives, itching, or skin rash
• itching, scaling, severe redness, soreness, or swelling of the skin
• runny or stuffy nose
• sneezing

Less common

• Acid or sour stomach
• back pain
• belching
• bloated or full feeling
• body aches or pain
• congestion
• cough
• difficulty having a bowel movement (stool)
• difficulty with moving
• dryness or soreness of the throat
• excess air or gas in the stomach or intestines
• heartburn
• hoarseness
• indigestion
• joint pain
• leg cramps
• muscle aches, cramps, pains, or stiffness
• passing gas
• stomach discomfort, upset, or pain
• swollen joints
• tender, swollen glands in the neck
• tooth problems
• voice changes

For Healthcare Professionals

Applies to selegiline: compounding powder, oral capsule, oral tablet, oral tablet disintegrating, transdermal film extended release.

General

In prospective pre-marketing studies, the most commonly reported side effects leading to treatment discontinuation with selegiline (the active ingredient contained in Emsam) oral tablets were, in decreasing order of frequency, nausea, hallucinations, confusion, depression, loss of balance, insomnia, orthostatic hypotension, increased akinetic involuntary movements, agitation, arrhythmia, bradykinesia, chorea, delusions, hypertension, new or increased angina pectoris, and syncope.

In clinical trials with selegiline orally disintegrating tablets, the most commonly reported side effects leading to treatment discontinuation were dizziness, chest pain, accidental injury, and myasthenia. The relative risk for treatment-emergent hypertension and orthostatic or postural hypotension was reported as being at least 2 fold greater in patients 65 years or older compared to those younger than 65 years. Patients over 65 years were also reported at an increased risk for somnolence compared to younger patients.

In clinical trials with selegiline transdermal patches, application site reaction was reported as the side effect that lead to treatment discontinuation in at least 1% of patients at a rate at least twice that of placebo.

Selegiline potentiates the effects of levodopa; therefore, the side effects of levodopa may be emphasized unless the levodopa dose is reduced.^[Ref]

Psychiatric

Very common (10% or more): Insomnia

Common (1% to 10%): Anxiety/tension, confusion, depression, euphoria, hallucinations, illusion, sleeping disorders, vivid dreams

Uncommon (0.1% to 1%): Abnormal dreams, agitation, manic reaction, mild transient irritability, mood change, psychoses

Frequency not reported: Apathy, delusions, disorientation, dreams/nightmares, hollow feeling, overstimulation, personality change, sleep disturbance, transient high, transient irritability

Postmarketing reports: Abnormal thinking, aggressive reaction, bruxism, delirium, impulse control disorders and compulsions, nervousness, paranoid reaction, paroniria, psychotic-like behavior^[Ref]

Insomnia and sleep disorder were reported as very common side effects with selegiline in double-blind placebo-controlled clinical trials at a higher frequency when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease. Insomnia was also reported as a very common side effect in placebo-controlled clinical trials for major depressive disorder with transdermal selegiline.

Parkinson's disease patients treated with dopamine agonists and/or other dopaminergic treatments such as selegiline have been reported as exhibiting impulse control disorders such as pathological gambling, increased libido, hypersexuality, compulsive spending/buying, and binge eating. There have been very few cases reported with selegiline. In some cases, dose reduction or treatment discontinuation led to cessation of impulse control disorders.

Postmarketing reports have indicated that patients taking this drug may experience new or worsening mental status and behavioral changes, such as psychotic-like behavior, particularly after starting therapy or increasing the dose. Certain medications used to treat psychosis (e.g., dopamine antagonists) may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of selegiline. Transient high and bruxism were reported at doses greater than 10 mg per day.

Anxiety was reported as a very common side effect with selegiline in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.

Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.

Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.^[Ref]

Nervous system

Very common (10% or more): Dizziness/lightheadedness/fainting

Common (1% to 10%): Abnormal movements (e.g., dyskinesias, bradykinesia, akinesia), ataxia, headache, impaired balance, lethargy, somnolence, syncope, tremor

Frequency not reported: Chorea, drowsiness, dyskinesia, dystonic symptoms, facial grimace, festination, impaired memory, increased apraxia, involuntary movements, migraine, myoclonic jerks, numbness of toes/fingers, restlessness, speech affected, supraorbital pain, tardive dyskinesia

Postmarketing reports: Abnormal gait, cerebrovascular disorder, coma, convulsions, hypertonia, involuntary muscle contractions, neuroleptic malignant syndrome, serotonin syndrome, taste disturbance^[Ref]

There have been reports of falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents, in Parkinson's disease patients treated with this drug. These reports have occurred in a setting of pre-existing somnolence.

Impaired memory and myoclonic jerks were reported at doses greater than 10 mg per day. Seizure in dialyzed chronic renal failure in a patient treated with selegiline on concomitant medications has been reported in postmarketing experience.

A symptom complex resembling the neuroleptic malignant syndrome, with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in, antiparkinson therapy.

There have been postmarketing reports of fatal and non-fatal cases of serotonin syndrome with concomitant use of this drug with antidepressants.

Headache was reported as a very common side effect in placebo-controlled clinical trials for major depressive disorder with transdermal selegiline.^[Ref]

Cardiovascular

Very common (10% or more): Postural hypotension

Common (1% to 10%): Arrhythmia, bradycardia, chest pain, hypertension, hypotension, edema, palpitations

Uncommon (0.1% to 1%): Angina pectoris, ankle edema, orthostatic hypotension, supraventricular tachycardia

Frequency not reported: Peripheral edema, hematoma, tachycardia

Postmarketing reports: Flushing, myocardial infarction^[Ref]

This drug inhibits the catabolism of dietary amines such as tyramine, and has the potential to produce a hypertensive crisis following the ingestion of tyramine-rich foods or beverages.

Postural hypotension was reported with selegiline in double-blind placebo-controlled clinical trials at a higher frequency when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease compared to the late phase. Palpitation was also reported as a very common side effect in the earlier phases of Parkinson's disease in these trials.^[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth, irritation of the buccal mucosa (orally disintegrating tablet), mouth ulceration, nausea, stomatitis

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, dysphagia, eructation, flatulence, gastric irritation, tooth disorder, vomiting

Frequency not reported: Gastrointestinal bleeding (exacerbation of pre-existing ulcer disease), heartburn, rectal bleeding, throat burning^[Ref]

Constipation was reported as a very common side effect with selegiline in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.^[Ref]

Other

Increased energy was reported at doses greater than 10 mg per day.

Vertigo was a very common side effect reported with selegiline (the active ingredient contained in Emsam) in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa compared with its use as monotherapy.^[Ref]

Very common (10% or more): Fatigue

Common (1% to 10%): Fall, pain, vertigo

Frequency not reported: Chills, generalized ache, falling down, freezing, heavy leg, increased energy, malaise, tinnitus, tiredness, weakness

Postmarketing reports: Asthenia, death, fever^[Ref]

Dermatologic

Very common (10% or more): Rash

Common (1% to 10%): Ecchymosis, increased sweating, skin disorders

Uncommon (0.1% to 1%): Hair loss, skin eruptions

Frequency not reported: Facial hair, photosensitivity^[Ref]

Skin disorders reported with this drug have included skin ulcer, fungal dermatitis, skin hypertrophy, contact dermatitis, herpes simplex, dry skin, sweating, urticaria, and pruritus.^[Ref]

Genitourinary

Very common (10% or more): Micturition disorder

Common (1% to 10%): Urinary retention

Frequency not reported: Hypersexuality, nocturia, penile sensation, prostatic hypertrophy, sexual dysfunction, slow urination, transient anorgasmia, urinary frequency, urinary hesitancy

Postmarketing reports: Increased libido^[Ref]

Transient anorgasmia and decreased penile sensation were reported at doses greater than 10 mg per day. The estimates of the incidence of untoward sexual experience and performance may also underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue.^[Ref]

Hematologic

Uncommon (0.1% to 1%): Leucocytopenia, thrombocytopenia^[Ref]

Hepatic

Common (1% to 10%): ALT/AST increased

Uncommon (0.1% to 1%): Transient increase in liver enzyme values^[Ref]

Local

Very common (10% or more): Application site reactions (transdermal patch)^[Ref]

Application site reactions with the transdermal patch were primarily described as erythema and resolved spontaneously with no treatment.^[Ref]

Metabolic

Very common (10% or more): Anorexia

Common (1% to 10%): Hypokalemia, weight loss

Uncommon (0.1% to 1%): Loss of appetite

Postmarketing reports: Hyperglycemia, hypoglycemia^[Ref]

The 1.25 mg orally disintegrating tablet contains 1.25 mg phenylalanine.

Anorexia was reported as a very common side effect with selegiline in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, leg cramps, leg pain, low back pain, myalgia, musculoskeletal injuries, muscle cramps

Uncommon (0.1% to 1%): Myopathy

Frequency not reported: Muscle twitch, stiff neck

Postmarketing reports: Muscle weakness (myasthenia)^[Ref]

Muscle twitch was reported at doses greater than 10 mg per day.^[Ref]

Ocular

Common (1% to 10%): Abnormal accommodation

Uncommon (0.1% to 1%): Blurred vision

Frequency not reported: Blepharospasm, diplopia

Postmarketing reports: Abnormal vision^[Ref]

Oncologic

Epidemiological studies have shown that Parkinson's disease patients are at a 2- to 6-fold increased risk of developing melanoma than the general population. It is unclear whether the observed increase in risk is due to Parkinson's disease or other factors.^[Ref]

Frequency not reported: Melanoma^[Ref]

Renal

Frequency not reported: Small increments in serum BUN and creatinine^[Ref]

Small increments in serum BUN and creatinine were observed with high doses of orally disintegrating selegiline (10 mg orally per day).^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, hiccup, nasal congestion, pharyngitis, rhinitis, sinusitis, sore throat

Frequency not reported: Asthma^[Ref]