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Selegiline (Selegiline) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Selegiline 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 (28)

Reports by Reaction Type

Hallucination, Visual (10)Pneumonia Aspiration (9)Intentional Overdose (9)Coma (9)Respiratory Failure (8)Convulsion (6)Confusional State (5)Dopamine Dysregulation Syndrome (5)ON and Off Phenomenon (5)Myoclonus (5)Suicide Attempt (5)Hypomania (4)

Possible Selegiline side effects in 65 year old female

Reported by a pharmacist from United States on 2012-07-30

Patient: 65 year old female, weighing 62.5 kg (137.5 pounds)

Reactions: Extrapyramidal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline

Other drugs received by patient: Diazepam; Aspirin; Amantadine HCL; Ropinorole; Dulcolax; Hydrocodone Bitartrate and Acetaminophen; Carbidopa and Levodopa



Possible Selegiline side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-10

Patient: 62 year old female

Reactions: Pathological Gambling, Condition Aggravated

Drug(s) suspected as cause:
Pramipexole Dihychloride
    Dosage: 2.1 mg/day
    Indication: Parkinson's Disease

Selegiline
    Dosage: 10 mg/day
    Indication: Parkinson's Disease

Sertraline Hydrochloride
    Dosage: 50 mg/ day
    Indication: Pathological Gambling



Possible Selegiline side effects in

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

Patient:

Reactions: Syncope, Dizziness, Drug Interaction

Drug(s) suspected as cause:
Clomipramine HCL

Selegiline

Methylphenidate



Possible Selegiline side effects in

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

Patient:

Reactions: Syncope, Drug Interaction, Dizziness

Drug(s) suspected as cause:
Selegiline

Methylphenidate

Clomipramine HCL



Possible Selegiline side effects in

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

Patient:

Reactions: Dopamine Dysregulation Syndrome, Drug Interaction, Gambling

Drug(s) suspected as cause:
Pramipexole Dihychloride

Levodopa

Selegiline
    Dosage: 10 mg



Possible Selegiline side effects in 55 year old male

Reported by a physician from Finland on 2012-06-26

Patient: 55 year old male

Reactions: Therapeutic Response Unexpected, Impulsive Behaviour

Drug(s) suspected as cause:
Carbidopa + Levodopa
    Dosage: 100/25-200/50 mg, daily
    Indication: Parkinson's Disease
    Start date: 2004-01-01

Cabergoline
    Dosage: 1-2 mg, daily
    Indication: Parkinson's Disease
    Start date: 2002-01-01

Selegiline
    Dosage: 5 mg, daily
    Indication: Parkinson's Disease
    Start date: 2001-01-01



Possible Selegiline side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-25

Patient: 62 year old female

Reactions: Pathological Gambling, Condition Aggravated

Drug(s) suspected as cause:
Pramipexole Dihychlloride
    Dosage: 2.1 mg/day
    Indication: Parkinson's Disease

Sertraline Hydrochloride
    Dosage: unk
    Indication: Pathological Gambling

Selegiline
    Indication: Parkinson's Disease



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-27

Patient: 50 year old male

Reactions: Confusional State, Pneumonia Aspiration, Intentional Overdose, Coma, Convulsion, Myoclonus, Hallucination, Visual, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trazodone HCL

Nitrazepam

Carbamazepine

Selegiline
    Dosage: 10 mg/daily
    Indication: Depression

Valproate Sodium



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-24

Patient: 50 year old male

Reactions: Pneumonia Aspiration, Intentional Overdose, Respiratory Failure, Hallucination, Visual, Coma, Serotonin Syndrome, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Start date: 2005-05-01

Selegiline
    Indication: Depression
    Start date: 2010-11-01

Nitrazepam
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Start date: 2005-05-01

Carbamazepine
    Indication: Intentional Overdose
    Start date: 2010-11-01

Trazodone HCL
    Indication: Intentional Overdose
    Start date: 2010-11-01

Valproic Acid
    Indication: Intentional Overdose
    Start date: 2010-11-01



Possible Selegiline side effects in 45 year old male

Reported by a individual with unspecified qualification from Finland on 2012-01-24

Patient: 45 year old male

Reactions: Anxiety, ON and Off Phenomenon, Apathy, Dopamine Dysregulation Syndrome, Overdose, Hypersexuality, Hypomania

Drug(s) suspected as cause:
Carbidopa + Levodopa
    Dosage: 400/100 mg daily

Pramipexole Dihychlloride
    Dosage: 2.1 mg, daily

Selegiline
    Dosage: 5 mg, daily

Amantadine HCL
    Dosage: 100 mg, daily

Pramipexole Dihychlloride
    Dosage: 2.8 mg, daily

Biperiden Hydrochloride TAB
    Dosage: 4 mg, daily

Carbidopa + Levodopa
    Dosage: 600/150/800 mg daily

Propranolol
    Dosage: 160 mg, daily

Carbidopa + Levodopa
    Dosage: 600/150/800 mg daily



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-24

Patient: 50 year old male

Reactions: Pneumonia Aspiration, Respiratory Failure, Intentional Overdose, Hallucination, Visual, Coma, Serotonin Syndrome, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Indication: Intentional Overdose
    Start date: 2010-11-01

Nitrazepam
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Indication: Depression
    Start date: 2010-11-01

Selegiline
    Start date: 2005-05-01

Trazodone HCL
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Start date: 2005-05-01

Valproic Acid
    Indication: Intentional Overdose
    Start date: 2010-11-01



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-24

Patient: 50 year old male

Reactions: Pneumonia Aspiration, Intentional Overdose, Coma, Serotonin Syndrome, Convulsion, Hallucination, Visual, Respiratory Failure, Multiple Drug Overdose Intentional

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Indication: Intentional Overdose
    Start date: 2010-11-01

Carbamazepine
    Indication: Intentional Overdose
    Start date: 2010-11-01

Trazodone HCL
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Start date: 2005-05-01

Nitrazepam
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Indication: Depression
    Start date: 2010-11-01

Selegiline
    Start date: 2005-05-01

Valproic Acid
    Indication: Intentional Overdose
    Start date: 2010-11-01



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-24

Patient: 50 year old male

Reactions: Pneumonia Aspiration, Intentional Overdose, Respiratory Failure, Hallucination, Visual, Coma, Serotonin Syndrome, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Start date: 2005-05-01

Carbamazepine
    Indication: Intentional Overdose
    Start date: 2010-11-01

Nitrazepam
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Start date: 2005-05-01

Selegiline
    Indication: Intentional Overdose
    Start date: 2010-11-01

Selegiline
    Indication: Depression
    Start date: 2010-11-01

Valproic Acid
    Indication: Intentional Overdose
    Start date: 2010-11-01

Trazodone HCL
    Indication: Intentional Overdose
    Start date: 2010-11-01



Possible Selegiline side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Finland on 2012-01-23

Patient: 45 year old male

Reactions: Apathy, Dopamine Dysregulation Syndrome, ON and Off Phenomenon, Anxiety, Hypersexuality, Hypomania

Drug(s) suspected as cause:
Selegiline
    Dosage: 5 mg, daily

Pramipexole Dihychlloride
    Dosage: 2.1 mg, daily

Amantadine HCL
    Dosage: 100 mg, daily

Pramipexole Dihychlloride
    Dosage: 2.8 mg, daily

Entacapone-Levodopa-Carbidopa
    Dosage: 400/100 mg daily

Propranolol
    Dosage: 160 mg, daily

Entacapone-Levodopa-Carbidopa
    Dosage: 600/150/800 mg daily

Biperiden Hydrochloride TAB
    Dosage: 4 mg, daily



Possible Selegiline side effects in male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-01-12

Patient: male

Reactions: Apathy, Polydipsia, Dopamine Dysregulation Syndrome, Hypersexuality, Intentional Drug Misuse, Hypomania

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Dosage: 5 mg
    Indication: Parkinson's Disease

Amantadine HCL
    Dosage: 100 mg
    Indication: Parkinson's Disease

Biperiden Hydrochloride TAB
    Dosage: 4 mg
    Indication: Parkinson's Disease

Pramipexole Dihychlloride
    Dosage: 2.1 mg

Carbidopa + Levodopa
    Dosage: levodopa/carbidopa 400/100 mg
    Indication: Parkinson's Disease

Pramipexole Dihychlloride
    Dosage: 4.2 mg

Pramipexole Dihychlloride
    Dosage: 2.8 mg
    Indication: Parkinson's Disease



Possible Selegiline side effects in male

Reported by a physician from United States on 2012-01-04

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Pulse Abnormal, Syncope, Atrial Flutter, Heart Rate Increased, Gait Disturbance

Drug(s) suspected as cause:
Selegiline

Other drugs received by patient: Eldepryl



Possible Selegiline side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-28

Patient: 69 year old female

Reactions: Gastrointestinal Hypomotility, Infrequent Bowel Movements

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Dosage: 5 mg, daily
    Indication: Parkinson's Disease

Entacapone
    Dosage: 300 mg, daily
    Indication: Parkinson's Disease

Levodopa
    Dosage: 900 mg, daily
    Indication: Parkinson's Disease



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-16

Patient: 50 year old male

Reactions: Overdose, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Indication: Depression
    Start date: 2005-05-01

Valproate Sodium
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Indication: Product Used FOR Unknown Indication

Trazodone HCL
    Indication: Product Used FOR Unknown Indication

Nitrazepam
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Hypnotics; Mood Stablizers



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-15

Patient: 50 year old male

Reactions: Confusional State, Pneumonia Aspiration, Intentional Overdose, Coma, Hyperhidrosis, Grand MAL Convulsion, Myoclonus, Hallucination, Visual, Respiratory Failure, Suicide Attempt, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Dosage: 10 mg, daily
    Indication: Depression
    Start date: 2005-05-01

Trazodone HCL
    Dosage: 2250 mg, unk
    Start date: 2010-11-01

Valproate Sodium
    Dosage: 16000 mg, unk
    Start date: 2010-11-01

Nitrazepam
    Dosage: 70 mg, unk
    Start date: 2010-11-01

Carbamazepine
    Dosage: 8600 mg, unk
    Start date: 2010-11-01

Selegiline
    Dosage: 195 mg, unk
    Start date: 2010-11-01

Trazodone HCL
    Dosage: unk



Possible Selegiline side effects in male

Reported by a health professional (non-physician/pharmacist) from Spain on 2011-12-15

Patient: male

Reactions: Dopamine Dysregulation Syndrome, Polydipsia, Apathy, Hypersexuality, Intentional Drug Misuse, Hypomania

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pramipexole Dihydrochloride
    Dosage: 4.2 mg

Selegiline
    Dosage: 5 mg
    Indication: Parkinson's Disease

Carbidopa + Levodopa
    Dosage: levodopa/carbidopa 400/100 mg
    Indication: Parkinson's Disease

Amantadine HCL
    Dosage: 100 mg
    Indication: Parkinson's Disease

Biperiden Hydrochloride TAB
    Dosage: 4 mg
    Indication: Parkinson's Disease

Pramipexole Dihydrochloride
    Dosage: 2.8 mg
    Indication: Parkinson's Disease

Pramipexole Dihydrochloride
    Dosage: 2.1 mg



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-15

Patient: 50 year old male

Reactions: Confusional State, Pneumonia Aspiration, Intentional Overdose, Coma, Hyperhidrosis, Myoclonus, Grand MAL Convulsion, Hallucination, Visual, Respiratory Failure, Suicide Attempt, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trazodone HCL
    Dosage: 2250 mg, unk
    Start date: 2010-11-01

Nitrazepam
    Dosage: 70 mg, unk
    Start date: 2010-11-01

Trazodone HCL
    Dosage: unk

Carbamazepine
    Dosage: 8600 mg, unk
    Start date: 2010-11-01

Selegiline
    Dosage: 195 mg, unk
    Start date: 2010-11-01

Valproate Sodium
    Dosage: 16000 mg, unk
    Start date: 2010-11-01

Selegiline
    Dosage: 10 mg, daily
    Indication: Depression
    Start date: 2005-05-01



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-09

Patient: 50 year old male

Reactions: Confusional State, Pneumonia Aspiration, Intentional Overdose, Coma, Hyperhidrosis, Myoclonus, Grand MAL Convulsion, Hallucination, Visual, Respiratory Failure, Suicide Attempt, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trazodone HCL
    Dosage: 2250 mg, unk
    Start date: 2010-11-01

Nitrazepam
    Dosage: 70 mg, unk
    Start date: 2010-11-01

Selegiline
    Dosage: 10 mg, daily
    Indication: Depression
    Start date: 2005-05-01

Carbamazepine
    Dosage: 8600 mg, unk
    Start date: 2010-11-01

Selegiline
    Dosage: 195 mg, unk
    Start date: 2010-11-01

Trazodone HCL
    Dosage: unk

Valproate Sodium
    Dosage: 16000 mg, unk
    Start date: 2010-11-01



Possible Selegiline side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-09

Patient: 50 year old male

Reactions: Confusional State, Pneumonia Aspiration, Intentional Overdose, Coma, Hyperhidrosis, Grand MAL Convulsion, Myoclonus, Hallucination, Visual, Respiratory Failure, Suicide Attempt, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Dosage: 10 mg, daily
    Indication: Depression
    Start date: 2005-05-01

Trazodone HCL
    Dosage: unk

Carbamazepine
    Dosage: 8600 mg, unk
    Start date: 2010-11-01

Selegiline
    Dosage: 195 mg, unk
    Start date: 2010-11-01

Trazodone HCL
    Dosage: 2250 mg, unk
    Start date: 2010-11-01

Valproate Sodium
    Dosage: 16000 mg, unk
    Start date: 2010-11-01

Nitrazepam
    Dosage: 70 mg, unk
    Start date: 2010-11-01



Possible Selegiline side effects in 56 year old male

Reported by a physician from Germany on 2011-11-09

Patient: 56 year old male

Reactions: ON and Off Phenomenon, Sleep Disorder, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro

Levopar
    Dosage: 125 mg 3 x 1 tablet

Selegiline
    Dosage: 5 mg

Other drugs received by patient: Victoza; Metformin Hydrochloride; Ramipril; Ezedrol; Metformin HCL; Lantus; Hydrochlorothiazide; Amlodipine; Aspirin; Metformin Hydrochloride



Possible Selegiline side effects in 56 year old male

Reported by a physician from Germany on 2011-11-08

Patient: 56 year old male

Reactions: ON and Off Phenomenon, Sleep Disorder, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Selegiline
    Dosage: 5 mg

Levopar
    Dosage: 125 mg 3 x 1 tablet

Neupro

Other drugs received by patient: Aspirin; Ezedrol; Amlodipine; Metformin Hydrochloride; Metfformin Hydrochloride; Victoza; Hydrochlorothiazide; Lantus; Metformin Hydrochloride; Ramipril



Possible Selegiline side effects in 56 year old male

Reported by a physician from Germany on 2011-11-01

Patient: 56 year old male

Reactions: ON and Off Phenomenon, Sleep Disorder, Hallucination, Visual, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levopar
    Dosage: 125 mg 3 x 1 tablet

Selegiline
    Dosage: 5 mg

Neupro
    Indication: Parkinson's Disease

Other drugs received by patient: Metformin Hydrochloride; Victoza; Amlodipine; Lantus; Ramipril; Hydrochlorothiazide; Aspirin; Ezedrol; Metformin HCL; Metformin Hydrochloride



Possible Selegiline side effects in 34 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2011-10-14

Patient: 34 year old male

Reactions: Weight Increased, Middle Insomnia, Rapid Eye Movements Sleep Abnormal, Sleep Apnoea Syndrome, Binge Eating, Somnolence, Sleep-Related Eating Disorder

Drug(s) suspected as cause:
Amantadine HCL
    Dosage: 300 mg
    Indication: Parkinson's Disease

Selegiline
    Dosage: 10 mg
    Indication: Parkinson's Disease

Pramipexole Dihydrochloride
    Dosage: 4.5 mg
    Indication: Parkinson's Disease

Biperiden Hydrochloride TAB
    Dosage: 6 mg
    Indication: Parkinson's Disease



Possible Selegiline side effects in male

Reported by a physician from China on 2011-10-04

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Humerus Fracture, Joint Dislocation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ropinirole
    Dosage: 2mg per day
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2010-09-28

Selegiline
    Dosage: 5mg per day
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-02-01

Other drugs received by patient: Celecoxib; Madopar

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