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Emsam

Last reviewed on RxList: 7/26/2017
Emsam Side Effects Center

Last reviewed on RxList 7/26/2017

Emsam (selegiline transdermal system) is an antidepressant used to treat major depressive disorder in adults. Common side effects of Emsam include:

  • dizziness,
  • drowsiness,
  • application site reactions (redness, irritation, or itching),
  • tiredness,
  • weakness,
  • problems sleeping (insomnia),
  • constipation,
  • diarrhea,
  • upset stomach,
  • dry mouth,
  • headache,
  • muscle pain,
  • bruising,
  • itching or rash,
  • cough,
  • sore throat,
  • sinus pain, or
  • stuffy nose

You may have thoughts about suicide when you first start using an antidepressant such as Emsam, especially if you are younger than 24 years old. Tell your doctor immediately if this occurs.

The recommended starting dose and target dose for Emsam is 6 mg/24 hours. The patch should be applied to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh or the outer surface of the upper arm once every 24 hours. Many other medicines can interact with Emsam, causing serious medical problems. Tell your doctor all other prescription and over-the-counter medications and supplements you use. Emsam should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Emsam (selegiline transdermal system) 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.

Emsam Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Remove the skin patch and get emergency medical help if you have any of these signs of dangerously high blood pressure:

  • sudden and severe headache, blurred vision, buzzing in your ears, anxiety, confusion;
  • sweating, nausea, neck stiffness, chest pain, feeling short of breath; or
  • fast or pounding heartbeats, fluttering in your chest.

Call your doctor at once if you have a serious side effect such as:

  • pain or burning when you urinate;
  • swelling in your hands or feet; or
  • problems with speech or balance, seizure (convulsions), sudden numbness or weakness (especially on one side of the body).

Less serious side effects may include:

  • redness or itching where the patch is worn;
  • mild headache, muscle pain;
  • diarrhea, constipation, upset stomach, dry mouth;
  • sleep problems (insomnia);
  • mild bruising, itching or rash; or
  • cough, sore throat, sinus pain or stuffy nose.

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.

Read the entire detailed patient monograph for Emsam (Selegiline Transdermal System)

Emsam Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Patient Exposure

The premarketing development program for EMSAM included selegiline exposures in patients and/or normal subjects from two different groups of studies: 702 healthy subjects in clinical pharmacology/pharmacokinetics studies and 2,036 exposures from patients in controlled and uncontrolled major depressive disorder clinical trials. The conditions and duration of treatment with EMSAM varied and included double-blind, open-label, fixed-dose, and dose titration studies of short-term and longer-term exposures. Safety was assessed by monitoring adverse reactions, physical examinations, vital signs, body weights, laboratory analyses, and ECGs.

Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators. In the tables and tabulations that follow, standard COSTART terminology has been used to classify reported adverse reactions. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Reactions Leading To Discontinuation Of Treatment

Among 817 MDD patients treated with EMSAM at doses of either 3 mg per 24 hours (151 patients), 6 mg per 24 hours (550 patients) or 6 mg per 24 hours, 9 mg per 24 hours, and 12 mg per 24 hours (116 patients) in placebo-controlled trials of up to 8 weeks in duration, 7.1% discontinued treatment due to an adverse reaction as compared with 3.6% of 668 patients receiving placebo. The only adverse reaction associated with discontinuation, in at least 1% of EMSAM-treated patients at a rate at least twice that of placebo, was application site reaction (2% EMSAM vs. 0% placebo).

Adverse Reactions Occurring At An Incidence Of 2% Or More Among EMSAM-Treated Patients

Table 2 enumerates adverse reactions that occurred at an incidence of 2% or more (rounded to the nearest percent) among 817 MDD patients treated with EMSAM in doses ranging from 3 to 12 mg per 24 hours in placebo-controlled trials of up to 8 weeks in duration. Reactions included are those occurring in 2% or more of patients treated with EMSAM and for which the incidence in patients treated with EMSAM was greater than the incidence in placebo-treated patients.

One adverse reaction was associated with a reporting of at least 5% in the EMSAM group, and a rate at least twice that in the placebo group, in the pool of short-term, placebo-controlled studies: application site reactions (see Application Site Reactions, below). In one such study which utilized higher mean doses of EMSAM than that in the entire study pool, the following reactions met these criteria: application site reactions, insomnia, diarrhea, and pharyngitis.

Table 2: Treatment-Emergent Adverse Reactions: Incidence in Placebo-Controlled Clinical Trials for Major Depressive Disorder with EMSAM1

Body System/Preferred Term EMSAM
(N = 817)
Placebo
(N = 668)
(% of Patients Reporting Reaction)
Body as a Whole
  Headache 18 17
Digestive
  Diarrhea 9 7
  Dyspepsia 4 3
Nervous
  Insomnia 12 7
  Dry Mouth 8 6
Respiratory
  Pharyngitis 3 2
  Sinusitis 3 1
Skin
  Application Site Reaction 24 12
  Rash 4 2
1Reactions reported by at least 2% of patients treated with EMSAM are included, except the following reactions, which had an incidence on placebo treatment greater than or equal to EMSAM: infection, nausea, dizziness, pain, abdominal pain, nervousness, back pain, asthenia, anxiety, flu syndrome, accidental injury, somnolence, rhinitis, and palpitations.

Application Site Reactions

In the pool of short-term, placebo-controlled major depressive disorder studies, application site reactions (ASRs) were reported in 24% of EMSAM-treated patients and 12% of placebo-treated patients. Most ASRs were mild or moderate in severity. ASRs led to dropout in 2% of EMSAM-treated patients and no placebo-treated patients. In one such study which utilized higher mean doses of EMSAM, ASRs were reported in 40% of EMSAM-treated patients and 20% of placebo-treated patients. Most of the ASRs in this study were described as erythema and most resolved spontaneously, requiring no treatment. When treatment was administered, it most commonly consisted of dermatological preparations of corticosteroids.

Sexual Dysfunction

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment.

Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence. Table 3 shows that the incidence rates of sexual side effects in patients with major depressive disorder are comparable to the placebo rates in placebo-controlled trials.

Table 3: Incidence of Sexual Side Effects in Placebo-Controlled Clinical Trials with EMSAM

Adverse Reaction EMSAM Placebo
IN MALES ONLY
(N = 304) (N = 256)
Abnormal Ejaculation 1.0% 0.0%
Decreased Libido 0.7% 0.0%
Impotence 0.7% 0.4%
Anorgasmia 0.2% 0.0%
  IN FEMALES ONLY
  (N = 513) (N = 412)
Decreased Libido 0.0% 0.2%

There are no adequately designed studies examining sexual dysfunction with EMSAM treatment.

Vital Sign Changes

EMSAM and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure), and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. In the pool of short-term, placebo-controlled major depressive disorder studies, 3.0% of EMSAM-treated patients and 1.5% of placebo-treated patients experienced a low systolic blood pressure, defined as a reading less than or equal to 90 mmHg with a change from baseline of at least 20 mmHg. In one study which utilized higher mean doses of EMSAM, 6.2% of EMSAM-treated patients and no placebo-treated patients experienced a low standing systolic blood pressure by these criteria.

In the pool of short-term major depressive disorder trials, 9.8% of EMSAM-treated patients and 6.7% of placebo-treated patients experienced a notable orthostatic change in blood pressure, defined as a decrease of at least 10 mmHg in mean blood pressure with postural change.

Weight Changes

In placebo-controlled studies (6 to 8 weeks), the incidence of patients who experienced at least 5% weight gain or weight loss is shown in Table 4.

Table 4: Incidence of Weight Gain and Weight Loss in Placebo-Controlled Trials with EMSAM

Weight Change EMSAM
(N = 757)
Placebo
(N = 614)
Gained at least 5% 2.1% 2.4%
Lost at least 5% 5.0% 2.8%

In these trials, the mean change in body weight among EMSAM-treated patients was a 1.2 lbs loss compared to 0.3 lbs gain in placebo-treated patients.

Laboratory Changes

EMSAM and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with EMSAM.

Electrocardiogram Changes

Electrocardiograms (ECGs) from EMSAM (N = 817) and placebo (N = 668) groups in controlled studies were compared with respect to (1) mean change from baseline in various ECG parameters, and (2) the incidence of patients meeting criteria for clinically significant changes from baseline in these variables.

No clinically meaningful changes in ECG parameters from baseline to final visit were observed for patients in controlled studies.

Other Reactions Observed During The Premarketing Evaluation Of EMSAM

The following listing does not include reactions: 1) already listed elsewhere in labeling, 2) for which a causal relationship to drug was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

Cardiovascular System: Tachycardia.

Digestive System: Anorexia.

Nervous System: Agitation, amnesia, tremor, twitching.

Skin and Appendages: Pruritus.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of EMSAM.

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 causal relationship to drug exposure.

Nervous System: Convulsion and hypoesthesia.

Psychiatric System: Disorientation, hallucination (visual), and tension.

Read the entire FDA prescribing information for Emsam (Selegiline Transdermal System)

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© Emsam Patient Information is supplied by Cerner Multum, Inc. and Emsam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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