Emsam Side Effects

Generic name: selegiline

Medically reviewed by Drugs.com. Last updated on Oct 1, 2023.

Note: This document provides detailed information about Emsam Side Effects associated with selegiline. Some dosage forms listed on this page may not apply specifically to the brand name Emsam.

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

• chest pain (severe)
• enlarged pupils
• fast or slow heartbeat
• headache (severe)
• increase in unusual movements of the body
• increased sensitivity of the eyes to light
• increased sweating (possibly with fever or cold, clammy skin)
• mood or other mental changes
• nausea and vomiting (severe)
• stiff or sore neck

Less common or rare

• bloody or black, tarry stools
• bruising
• convulsions (seizures)
• decreased urine
• difficult or frequent urination
• difficulty with breathing
• difficulty with speaking
• difficulty with swallowing
• dizziness or lightheadedness, especially when getting up from a lying or sitting position
• dry mouth
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased thirst
• irregular heartbeat
• large, flat, blue, or purplish patches in the skin
• lip smacking or puckering
• loss of appetite
• loss of balance control
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• restlessness or desire to keep moving
• severe stomach pain
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• swelling of the feet or lower legs
• swelling or inflammation of the mouth
• tightness in the chest
• trembling or shaking of the hands or feet
• twisting movements of the body
• uncontrolled chewing movements
• uncontrolled movements of the face, neck, back, arms, or legs
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• wheezing

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

Symptoms of overdose

• agitation or irritability
• 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
• troubled 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

• abdominal or stomach pain
• dizziness or feeling faint
• runny nose
• sneezing
• stuffy nose
• trouble with sleeping

Less common or rare

• anxiety
• back or leg pain
• blurred or double vision
• body aches or pain
• burning of the lips, mouth, or throat
• chills
• constipation
• cough
• diarrhea
• drowsiness
• dryness or soreness of the throat
• frequent urge to urinate
• headache
• heartburn
• inability to move
• increased sweating
• irritability (temporary)
• memory problems
• nervousness
• pounding or fast heartbeat
• rash
• red, raised, or itchy skin
• ringing or buzzing in the ears
• slow or difficult urination
• slowed movements
• taste changes
• uncontrolled closing of the eyelids
• unusual feeling of well-being
• unusual weight loss
• 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 (the active ingredient contained in Emsam) 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 (the active ingredient contained in Emsam) in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.^[Ref]

Other

• 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]

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]

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

• Frequency not reported: Melanoma^[Ref]

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]

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]

Further information

Emsam 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.

Some side effects may not be reported. You may report them to the FDA.

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