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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 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 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 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, weighing 106.6 kg (234.5 pounds)

Reactions: Prostatitis, Prostatomegaly, Pollakiuria, Urinary Retention

Drug(s) suspected as cause:
Emsam
    Dosage: applied qod
    Indication: Major Depression
    Start date: 2011-11-16
    End date: 2012-01-01

Emsam
    Start date: 2011-11-16
    End date: 2012-01-01

Other drugs received by patient: Risperidone; Klonopin; Zyrtec; Lamictal



Possible Emsam side effects in 45 year old female

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

Patient: 45 year old female

Reactions: Application Site Pain, Application Site Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Blood Pressure Medication; Lamotrgine; Lunesta



Possible Emsam side effects in male

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

Patient: male, weighing 95.3 kg (209.6 pounds)

Reactions: Application Site Erythema, Application Site Rash

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Lipitor; Lamictal; Aspirin; Toprol-XL



Possible Emsam side effects in male

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

Patient: male

Reactions: Drug Ineffective, Depression

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: Myalgia, Muscle Spasms

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 46 year old female

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

Patient: 46 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Blood Pressure Increased, Palpitations

Drug(s) suspected as cause:
Emsam
    Indication: Major Depression
    Start date: 2012-12-01

Emsam
    Indication: Post-Traumatic Stress Disorder
    Start date: 2012-12-01

Emsam
    Indication: Agoraphobia
    Start date: 2012-12-01

Other drugs received by patient: Klonopin; Depo-Provera; Xanax; Xanax; Xanax



Possible Emsam side effects in female

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

Patient: female

Reactions: Anxiety, Food Interaction, Blood Pressure Increased, Neck Pain, Temperature Intolerance, Headache, Tremor

Drug(s) suspected as cause:
Emsam
    Dosage: changed qday
    End date: 2010-01-01

Emsam
    Dosage: changed qday
    Indication: Depression
    Start date: 2011-02-15

Emsam
    Dosage: changed qday
    Start date: 2007-01-01
    End date: 2010-01-01

Emsam
    Dosage: changed qday
    End date: 2010-01-01

Emsam
    Dosage: changed qday
    Indication: Anxiety
    Start date: 2011-02-15

Emsam
    Dosage: changed qday
    Start date: 2010-01-01
    End date: 2011-02-14

Emsam
    Dosage: changed qday
    Start date: 2007-01-01
    End date: 2010-01-01

Emsam
    Dosage: changed qday
    Start date: 2010-01-01
    End date: 2011-02-14

Other drugs received by patient: Gabapentin; Ativan; Protonix



Possible Emsam side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Insomnia

Drug(s) suspected as cause:
Emsam
    Start date: 2011-05-12

Emsam
    Start date: 2011-04-18
    End date: 2011-05-12



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: Drug Ineffective, Depression

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Coumadin; Atacand; Lithium Carbonate; Protonix



Possible Emsam side effects in 34 year old male

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

Patient: 34 year old male, weighing 235.9 kg (518.9 pounds)

Reactions: Proteinuria, Urine Colour Abnormal, Dysuria, Urinary Hesitation

Drug(s) suspected as cause:
Emsam
    Dosage: qd
    Indication: Depression
    Start date: 2011-10-01
    End date: 2011-11-30

Emsam
    Dosage: changed q24h
    Start date: 2011-12-01
    End date: 2011-12-04

Other drugs received by patient: Nexium; Levothyroxine Sodium; Restoril; Lisinopril; Hydrocodone; Proair HFA



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, Skin Burning Sensation, Rash, Application Site Rash, Application Site Vesicles, Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Amlodipine; Nexium; Percocet; Cozaar; Lithium Carbonate; Synthroid; Lyrica



Possible Emsam side effects in 59 year old female

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

Patient: 59 year old female

Reactions: Application Site Inflammation, Application Site Erythema, Application Site Rash

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: Drug Ineffective, Chills, Pain, Change in Sustained Attention, Weight Increased, Anxiety, Irritability, Insomnia, Depression

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 61 year old female

Reported by a individual with unspecified qualification from United States on 2012-03-29

Patient: 61 year old female

Reactions: Application Site Inflammation, Application Site Exfoliation, Application Site Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Emsam
    Dosage: changed q24hrs
    Start date: 2010-04-17

Emsam
    Dosage: changed daily
    Indication: Depression
    Start date: 2010-04-01
    End date: 2010-04-17

Other drugs received by patient: Vitamin; Vitamin D; Medrol; Liothyronine Sodium; Restoril; Claritin / 00917501 /



Possible Emsam side effects in male

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

Patient: male

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in

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

Patient:

Reactions: Rash

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: Drug Ineffective, Depression

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: Blood Pressure Increased

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

Emsam
    Indication: Depression
    Start date: 2011-04-14

Emsam
    Indication: Suicidal Ideation
    Start date: 2011-04-14

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



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

Reactions: Dyspnoea, Urinary Tract Infection, DRY Mouth, Oropharyngeal Pain, Pharyngitis

Drug(s) suspected as cause:
Emsam



Possible Emsam side effects in 66 year old female

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

Patient: 66 year old female

Reactions: Nasopharyngitis, Application Site Erythema

Drug(s) suspected as cause:
Emsam

Other drugs received by patient: Micardis; Nasonex; Seroquel; Meloxicam



Possible Emsam side effects in female

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

Patient: female

Reactions: Drug Ineffective, Impulsive Behaviour, Depression, Intentional Self-Injury, Suicidal Ideation

Drug(s) suspected as cause:
Emsam
    Dosage: changed q24h
    Indication: Depression
    Start date: 2011-02-24
    End date: 2011-03-06

Emsam
    Dosage: changed q24h
    Start date: 2011-03-06
    End date: 2011-03-17

Lamictal
    Administration route: Oral
    Indication: Affective Disorder

Other drugs received by patient: Klonopin



Possible Emsam side effects in 43 year old female

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

Patient: 43 year old female

Reactions: Rash Generalised

Drug(s) suspected as cause:
Emsam

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