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Emsam (Selegiline Transdermal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Emsam (Selegiline Transdermal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (132)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Application Site Erythema (24)Application Site Rash (17)Drug Ineffective (15)Depression (15)Insomnia (14)Application Site Pruritus (13)Application Site Vesicles (8)Headache (7)Drug Effect Decreased (7)Anxiety (7)Application Site Urticaria (7)Application Site Irritation (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Emsam (Selegiline Transdermal). For a complete list or a specific selection of reports, please use the links above.

Possible Emsam side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 71 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Confusional State, Movement Disorder, Cognitive Disorder, non-Cardiac Chest Pain, Somnolence, Myalgia, Speech Disorder, Slow Response To Stimuli, Ecchymosis, Insomnia, Bradyphrenia, Obsessive Thoughts, Feeling Abnormal, Hallucination

Drug(s) suspected as cause:
Emsam
    Dosage: changed qday
    Indication: Depression
    Start date: 2011-04-07
    End date: 2011-04-08

Emsam
    Dosage: changed qday
    Indication: Bipolar Disorder
    Start date: 2011-04-07
    End date: 2011-04-08

Mirtazapine

Other drugs received by patient: Evista; Gabapentin; Aspirin; Intal; Vitamins, Other Combinations; Cozaar; Zetia; Quercetin; Vitamin D; Calcium Magnesium Citrate; Neurontin; Miralax / 00754501 /; Coq10; Calcium; Magnesium Sulfate; Magnesium Sulfate; Allopurinol; Oxycodone HCL; Fish OIL; Citracal / 01606701 /; Collagen Bovine; Tylenol Extended Relief; Digestive AID; Clonazepam; D-Mannose; Vitamin; Resveratrol; Bilberry + Lutein; Lipitor; Singulair; Multi-Vitamin; Green TEA / 01578101 /; Astaxanthin; Herbal Liver Form; Mirtazapine; Advair; Mirapex



Possible Emsam side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: 59 year old male

Reactions: Weight Decreased, Headache, Hypoaesthesia, Facial Pain, Abdominal Pain Upper, Oral Discomfort, Diplopia, Rhinalgia, DRY Mouth, Burning Mouth Syndrome, Cholecystectomy, Salivary Hypersecretion, Toothache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2011-11-26
    End date: 2012-04-07

Emsam
    Dosage: qd
    Start date: 2012-04-08
    End date: 2012-05-18

Other drugs received by patient: Metformin HCL; Percocet; Androgel; Xanax; Aspirin; Crestor; Synthroid; Ambien; Vitamin D



Possible Emsam side effects in 44 year old female

Reported by a pharmacist from United States on 2012-07-02

Patient: 44 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Drug Dose Omission, Convulsion

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female

Reactions: Gastrointestinal Infection, Weight Decreased, Drug Effect Decreased, Dehydration, Hernia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Xanax



Possible Emsam side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient: 46 year old female, weighing 113.4 kg (249.5 pounds)

Reactions: Serotonin Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: 59 year old male

Reactions: Weight Decreased, Hypoaesthesia, Abdominal Pain Upper, Oral Discomfort, Diplopia, Rhinalgia, DRY Mouth, Burning Mouth Syndrome, Cholecystectomy, Salivary Hypersecretion, Toothache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2011-11-26
    End date: 2012-04-07

Emsam
    Dosage: qd
    Start date: 2012-04-08
    End date: 2012-05-18

Other drugs received by patient: Synthroid; Metformin HCL; Vitamin D; Crestor; Ambien; Xanax; Percocet; Androgel; Aspirin



Possible Emsam side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23

Patient: 59 year old male

Reactions: Weight Decreased, DRY Mouth, Burning Mouth Syndrome, Cholecystectomy, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emsam
    Dosage: qd
    Start date: 2012-04-08

Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2011-12-26
    End date: 2012-04-07

Other drugs received by patient: Synthroid; Ambien; Metformin HCL; Androgel; Percocet; Crestor



Possible Emsam side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-29

Patient: female

Reactions: Application Site Erythema, Application Site Rash

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: male

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Emsam
    Dosage: changes q.d.

Emsam
    Dosage: changes q.d.



Possible Emsam side effects in male

Reported by a physician from United States on 2012-03-29

Patient: male

Reactions: Application Site Irritation

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 26 year old female

Reported by a physician from United States on 2012-03-29

Patient: 26 year old female

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 38 year old male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 38 year old male, weighing 190.5 kg (419.1 pounds)

Reactions: Application Site Rash

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 40 year old female

Reactions: Anxiety, Weight Decreased, Insomnia, Depression, Decreased Appetite

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 55 year old male

Reactions: Application Site Urticaria, Application Site Erythema

Drug(s) suspected as cause:
Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2010-01-01

Testosterone
    Start date: 2009-01-01

Other drugs received by patient: Xanax; Vitamin D; Multi-Vitamin



Possible Emsam side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Application Site Erythema, Application Site Vesicles

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Dyspnoea, Nausea, Insomnia

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 61 year old female

Reactions: Application Site Reaction, Application Site Discolouration, Middle Insomnia, Application Site Scar

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Lithium Carbonate; Lorazepam



Possible Emsam side effects in female

Reported by a physician from United States on 2012-03-29

Patient: female

Reactions: Application Site Vesicles

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a physician from United States on 2012-03-29

Patient: female

Reactions: Drug Screen False Positive

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Photosensitivity Reaction, Myalgia, Fatigue, Nausea, Insomnia, Headache, Suicidal Ideation

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-29

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Muscle Tightness

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Abilify; Cytomel



Possible Emsam side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Application Site Rash, Application Site Pruritus

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-29

Patient: female

Reactions: Contusion, Pain, Rash

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 28 year old male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 28 year old male

Reactions: Application Site Urticaria, Application Site Warmth, Application Site Erythema, Application Site Erosion, Application Site Irritation

Drug(s) suspected as cause:
Emsam
    Indication: Depression
    Start date: 2010-01-01

Emsam



Possible Emsam side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: male

Reactions: Nightmare, Insomnia

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 63 year old female

Reactions: Application Site Rash

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 47 year old female

Reactions: Application Site Urticaria, Application Site Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Emsam
    Dosage: changed q24h
    Start date: 2011-04-01

Emsam
    Dosage: changed q24h
    Indication: Major Depression
    Start date: 2011-03-01
    End date: 2011-04-01



Possible Emsam side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 58 year old female

Reactions: Abnormal Behaviour

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Atenolol; Dilantin



Possible Emsam side effects in 65 year old male

Reported by a pharmacist from United States on 2012-03-29

Patient: 65 year old male

Reactions: Drug Ineffective, Depression

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Application Site Urticaria

Drug(s) suspected as cause:
Emsam

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