Emsam Side Effects
Generic Name: selegiline
Note: This page contains information about the side effects of selegiline. Some of the dosage forms included on this document may not apply to the brand name Emsam.
Not all side effects for Emsam may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to selegiline: oral capsule, oral tablet, oral tablet disintegrating
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by selegiline (the active ingredient contained in Emsam). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when 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
- Bloody or black, tarry stools
- 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
If any of the following symptoms of overdose occur while taking selegiline, get emergency help immediately: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
Some of the side effects that can occur with selegiline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Abdominal or stomach pain
- dizziness or feeling faint
- runny nose
- stuffy nose
- trouble with sleeping
- back or leg pain
- blurred or double vision
- body aches or pain
- burning of the lips, mouth, or throat
- dryness or soreness of the throat
- frequent urge to urinate
- inability to move
- increased sweating
- irritability (temporary)
- memory problems
- pounding or fast heartbeat
- 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
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 (the active ingredient contained in Emsam) 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.
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 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 (the active ingredient contained in Emsam) 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.
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 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.
Anticholinergic effects have been reported and include dry mouth, blurred vision, urinary retention and constipation.
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 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 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 side effects have included diplopia and blurred vision.
Respiratory side effects have bronchitis, increased cough, dyspnea, asthma, pneumonia, and laryngismus. Epistaxis, laryngitis, and yawn have also been reported rarely.
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 side effects have included ecchymosis, anemia, and lymphadenopathy. Leukocytosis, leukopenia, and petechiae have also been reported rarely.
Musculoskeletal side effects have included myalgia, pathological fracture, arthralgia, generalized spasm, arthritis, myasthenia, arthrosis, and tenosynovitis. Osteoporosis has also been reported rarely.
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 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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