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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 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 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 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



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 62 year old male

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

Patient: 62 year old male

Reactions: Application Site Erythema, Application Site Rash, Application Site Irritation

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 72 year old male

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

Patient: 72 year old male

Reactions: Drug Ineffective, Insomnia, Dizziness, Depression

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Lovastatin; Cartia XT; Seroquel; Diltiazem HCL; Levothyroxine Sodium; Multi-Vitamin; Warfarin Sodium; Pramipexole Dihydrochloride; Sotalol HCL; Lorazepam; Insulin



Possible Emsam side effects in male

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

Patient: male

Reactions: Balance Disorder, Blood Sodium Decreased

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Vitamin TAB; Lisinopril; Zocor; Tamsulosin HCL; Fish OIL; Plavix; Metoprolol Succinate



Possible Emsam side effects in 68 year old male

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

Patient: 68 year old male

Reactions: Nausea, Dizziness, Headache, Abdominal Pain Upper

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 57 year old male

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

Patient: 57 year old male

Reactions: Drug Ineffective, Suicidal Ideation, Hypersomnia, Delusion

Drug(s) suspected as cause:
Emsam
    Start date: 2011-04-14

Emsam
    Indication: Suicidal Ideation
    Start date: 2011-03-09
    End date: 2011-04-14

Emsam
    Start date: 2011-04-14

Emsam
    Indication: Delusion
    Start date: 2011-03-09
    End date: 2011-04-14

Emsam
    Indication: Depression
    Start date: 2011-03-09
    End date: 2011-04-14

Emsam
    Start date: 2011-04-14

Other drugs received by patient: Ursodiol; Levothyroxine Sodium; Nifedipine



Possible Emsam side effects in 80 year old

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

Patient: 80 year old

Reactions: Dermatitis Contact

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, weighing 77.1 kg (169.6 pounds)

Reactions: 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: Application Site Reaction, Application Site Discolouration, Application Site Erythema, Application Site Vesicles, Application Site Irritation

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in

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

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 70 year old male

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

Patient: 70 year old male

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Lipitor; Lisinopril; Lamotrgine



Possible Emsam side effects in male

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

Patient: male

Reactions: Application Site Erythema

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: Dysphonia, Oedema Peripheral, Pulmonary Oedema, Myocardial Oedema

Drug(s) suspected as cause:
Emsam
    Indication: Depression
    Start date: 2010-12-01

Lithium Carbonate



Possible Emsam side effects in 57 year old female

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

Patient: 57 year old female, weighing 70.8 kg (155.7 pounds)

Reactions: Blood Pressure Increased, Insomnia, Amnesia, Tremor

Drug(s) suspected as cause:
Emsam
    Dosage: qd

Emsam
    Dosage: qd

Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2007-05-01

Other drugs received by patient: Plaquenil; Synthroid; Cozaar; Amlodipine; Lithium Carbonate



Possible Emsam side effects in 78 year old female

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

Patient: 78 year old female

Reactions: Drug Interaction, Sinusitis

Drug(s) suspected as cause:
Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2006-01-01

Steroids
    Indication: Spinal Column Stenosis
    Start date: 2011-01-01

Other drugs received by patient: Synthroid; Norvasc



Possible Emsam side effects in female

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

Patient: female

Reactions: Hypersensitivity, Application Site Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Warfarin Sodium; Nasonex; Tylenol; Pulmicort

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