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Neupro (Rotigotine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Neupro (Rotigotine) 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 (167)
Death (21)
Life Threatening Events (7)
Disability (4)

Reports by Reaction Type

Drug Ineffective (12)Parkinson's Disease (12)Sopor (8)Pruritus (7)Somnolence (7)Dyspnoea (7)Atrial Fibrillation (7)Urticaria (6)Erythema (6)Fall (6)Application Site Pruritus (6)Death (6)

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

Possible Neupro side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 64 year old female

Reactions: Self-Injurious Ideation

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Stalevo 100



Possible Neupro side effects in 64 year old male

Reported by a consumer/non-health professional from Netherlands on 2012-08-24

Patient: 64 year old male

Reactions: Syncope, Vomiting, Listless, Drug Ineffective, Restless Legs Syndrome, Seizure Like Phenomena

Drug(s) suspected as cause:
Neupro



Possible Neupro side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-08-17

Patient: male

Reactions: Vomiting, Syncope, Listless, Seizure Like Phenomena

Drug(s) suspected as cause:
Neupro



Possible Neupro side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 56 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Venlafaxine; Trospium Chloride; Solifenacin Succinate; Carbidopa and Levodopa; Carbidopa and Levodopa; Venlafaxine; Rasagiline



Possible Neupro side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 56 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Confusional State, Thrombosis, Fall, Somnolence, Resuscitation

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Trospium-Sanctura; Solifenacin Succinate; Effexor; Rasagiline-Azilect; Sinemet; Sinemet



Possible Neupro side effects in female

Reported by a consumer/non-health professional from Australia on 2012-08-14

Patient: female

Reactions: Drug Hypersensitivity, Lung Neoplasm

Drug(s) suspected as cause:
Neupro



Possible Neupro side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: female

Reactions: Self-Injurious Ideation

Drug(s) suspected as cause:
Neupro



Possible Neupro side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Drug Ineffective, Application Site Pruritus, Ovarian Cancer

Drug(s) suspected as cause:
Neupro

Neupro
    Start date: 2012-07-16
    End date: 2012-07-01

Neupro
    Start date: 2012-07-01
    End date: 2012-01-01



Possible Neupro side effects in 65 year old female

Reported by a physician from Germany on 2012-08-03

Patient: 65 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Breast Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro
    Start date: 2010-11-20
    End date: 2010-11-26

Neupro
    Start date: 2011-03-16
    End date: 2011-06-28

Neupro
    Indication: Parkinson's Disease
    Start date: 2011-01-01

Neupro
    Start date: 2011-06-29
    End date: 2011-09-20

Neupro
    Start date: 2011-09-21
    End date: 2011-01-01

Neupro
    Start date: 2010-11-27
    End date: 2011-03-15

Other drugs received by patient: Stalevo 100; Ergocalciferol; Calcium D3; PK Merz; Cosopt; Levocomp; Levocomp Retard; PK Merz; Alendron; Calcimagon D3; Levocomp Retard; Madopar LT



Possible Neupro side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-31

Patient: male

Reactions: Death, Rash

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupro
    Start date: 2008-10-01
    End date: 2008-01-01

Neupro
    Start date: 2008-01-01

Neupro
    Start date: 2008-01-01
    End date: 2008-01-01

Neupro
    Start date: 2008-01-01
    End date: 2008-01-01



Possible Neupro side effects in 77 year old female

Reported by a physician from Germany on 2012-07-30

Patient: 77 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Dyspnoea, Cardiac Failure, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Indication: Cardiac Disorder

Bisoprolol Fumarate
    Indication: Arrhythmia

Digitoxin TAB
    Indication: Cardiac Disorder

Diovan
    Indication: Hypertension
    Start date: 2010-05-20

Falithrom
    Indication: Cardiac Failure
    Start date: 2010-05-20
    End date: 2010-06-09

Isosorbide Dinitrate
    Indication: Hypertension
    Start date: 2010-05-20
    End date: 2010-06-09

Neupro
    Indication: Parkinson's Disease
    Start date: 2010-04-09
    End date: 2010-05-05

Neupro
    Start date: 2010-05-28

Neupro
    Start date: 2010-05-06
    End date: 2010-05-27

Torsemide
    Indication: Hypertension

Other drugs received by patient: Pantoprazole; Ramipril; Felopuren; Simvastatin; Allopurinol; Nephrotrans; Valproate Sodium



Possible Neupro side effects in 57 year old male

Reported by a physician from Germany on 2012-07-30

Patient: 57 year old male

Reactions: Parkinson's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarium
    Indication: Parkinson's Disease
    Start date: 2008-11-04
    End date: 2008-11-08

Clarium
    Start date: 2008-11-11
    End date: 2009-03-12

Clarium
    Start date: 2008-11-09
    End date: 2008-11-10

Clarium
    Dosage: dose decreased
    Start date: 2010-10-04

Clarium
    Dosage: frequency: other 2-1-1
    Start date: 2009-11-10
    End date: 2010-10-03

Clarium
    Dosage: frequency: other 2-0-1
    Start date: 2009-05-09
    End date: 2009-11-09

Clarium
    Dosage: dose: other 2-1-1
    Start date: 2009-03-13
    End date: 2009-06-08

Neupro
    Start date: 2009-05-01
    End date: 2009-05-07

Neupro
    Start date: 2010-10-12
    End date: 2010-10-12

Neupro
    Start date: 2009-06-26
    End date: 2010-10-04

Neupro
    Start date: 2010-10-05
    End date: 2010-10-07

Neupro
    Start date: 2010-10-13
    End date: 2010-10-13

Neupro
    Start date: 2008-06-09
    End date: 2008-06-19

Neupro
    Start date: 2008-06-20
    End date: 2008-06-22

Neupro
    Start date: 2009-06-08
    End date: 2009-06-25

Neupro
    Start date: 2010-10-08
    End date: 2010-10-11

Neupro
    Start date: 2010-10-18

Neupro
    Start date: 2008-06-23
    End date: 2008-11-02

Neupro
    Start date: 2009-03-03
    End date: 2009-04-30

Neupro
    Start date: 2010-10-14
    End date: 2010-10-17

Neupro
    Indication: Parkinson's Disease
    Start date: 2008-06-04
    End date: 2008-06-08

Neupro
    Start date: 2008-11-10
    End date: 2009-03-02

Neupro
    Start date: 2008-11-03
    End date: 2008-11-09

Primidone
    Start date: 2008-11-04
    End date: 2008-11-10

Primidone
    Indication: Parkinson's Disease
    Start date: 2008-07-07
    End date: 2008-07-08

Primidone
    Dosage: dose: other 2-0-1
    Start date: 2008-09-16
    End date: 2008-11-03

Primidone
    Start date: 2008-07-10
    End date: 2008-09-01

Primidone
    Dosage: other 1-0-2
    Start date: 2010-07-21
    End date: 2010-09-20

Primidone
    Start date: 2010-09-21
    End date: 2010-10-04

Primidone
    Start date: 2010-10-08

Primidone
    Start date: 2008-11-11
    End date: 2010-04-22

Primidone
    Start date: 2008-07-09
    End date: 2008-07-09

Primidone
    Start date: 2010-04-23
    End date: 2010-07-20

Primidone
    Start date: 2010-10-05
    End date: 2010-10-07

Selegelin
    Indication: Parkinson's Disease
    Start date: 2008-11-14
    End date: 2010-10-04

Other drugs received by patient: Levothyroxine Sodium; Madopar Depot; Clonazepam; Protaphane; Madopar Depot; Protaphane; Novorapid; Clonazepam; Moviprep; Madopar Depot; Levothyroxine Sodium; Madopar Depot



Possible Neupro side effects in 69 year old female

Reported by a physician from Germany on 2012-07-25

Patient: 69 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Drug Intolerance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Doxepin; Plavix; Enaplus; Jodid; Lacidipin; Simvastatin; Motens; Benalapril



Possible Neupro side effects in 62 year old male

Reported by a physician from Sweden on 2012-07-25

Patient: 62 year old male

Reactions: Aphasia, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Ibuprofen; Omeprazole; Panodil Film-Coated Tablet; Koffein Recip Tablet 100 MG



Possible Neupro side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-24

Patient: male, weighing 110.0 kg (242.0 pounds)

Reactions: Application Site Reaction, Dermatitis Allergic, Pathological Gambling, Libido Increased, Erectile Dysfunction

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Citalopram Hydrobromide; Tamsolusin Retard; Stalevo 100; Omeprazole; Levodop Retard; Metoprolol Succinate; Aspirin; Bromazanil; Amantadine HCL; Tambocor



Possible Neupro side effects in 74 year old male

Reported by a pharmacist from France on 2012-07-23

Patient: 74 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Paraesthesia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Omeprazole; Lasix; Zoladex; Arixtra; Tilcotil; Stalevo 100; Crestor; Anti-Diabetic Drug; Zolpidem



Possible Neupro side effects in 62 year old male

Reported by a physician from Sweden on 2012-07-20

Patient: 62 year old male

Reactions: Aphasia, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro
    Dosage: reduced dose

Neupro
    Indication: Parkinson's Disease

Other drugs received by patient: Omeprazole; Ibuprofen; Panodil Film-Coated Tablet; Koffein Recip Tablet 100 MG



Possible Neupro side effects in 80 year old male

Reported by a consumer/non-health professional from France on 2012-07-17

Patient: 80 year old male

Reactions: Nightmare, Somnolence, Fall, Decubitus Ulcer, Oedema Peripheral, Extrapyramidal Disorder, Deep Vein Thrombosis, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro
    Indication: Parkinson's Disease
    Start date: 2012-05-21
    End date: 2012-05-01

Neupro
    Start date: 2011-01-01
    End date: 2012-05-01

Other drugs received by patient: Sinemet; Nexium; Motilium; Sinemet



Possible Neupro side effects in 74 year old female

Reported by a physician from France on 2012-07-13

Patient: 74 year old female

Reactions: Application Site Reaction, Application Site Vesicles, Application Site Pruritus

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Sinemet



Possible Neupro side effects in 85 year old female

Reported by a consumer/non-health professional from Germany on 2012-07-13

Patient: 85 year old female

Reactions: Ill-Defined Disorder, Erythema, Application Site Pruritus, Application Site Irritation

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupro
    Dosage: 8 mg/24 h
    Start date: 2007-01-01

Neupro
    Dosage: 4 mg/24 h

Other drugs received by patient: Pramipexole Dihydrochloride; Madopar; Entacapone



Possible Neupro side effects in 76 year old female

Reported by a consumer/non-health professional from Germany on 2012-07-09

Patient: 76 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Product Quality Issue, Pruritus, Application Site Pustules, Alanine Aminotransferase Increased, Urticaria, Muscular Weakness, Skin Burning Sensation, Product Adhesion Issue, Erythema, Transaminases Increased, Tremor, Gamma-Glutamyltransferase Increased, Medication Error, Alopecia, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Neupro
    Indication: Parkinson's Disease
    Start date: 2012-04-01

Neupro
    Start date: 2012-04-10
    End date: 2012-04-25

Neupro
    Dosage: once daily at 06:00am
    Start date: 2012-03-10
    End date: 2012-01-01

Other drugs received by patient: Torsemide; Ergocalciferol; Omeprazole; Novalgin; Omega 3 KPS; Madopar LT; Aspirin; Madopar; Metoprolol Tartrate; Diovan; Pantoprazole Sodium; Estradiol; Diasporal Dinkt



Possible Neupro side effects in 68 year old male

Reported by a physician from Germany on 2012-07-06

Patient: 68 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Pleural Effusion

Drug(s) suspected as cause:
Neupro

Other drugs received by patient: Parkinsan; Selegilin; Lormetazepam; Carbidopa and Levodopa



Possible Neupro side effects in 85 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-06

Patient: 85 year old female

Reactions: Erythema, Ill-Defined Disorder, Application Site Pruritus, Skin Irritation

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupro
    Dosage: 8 mg

Neupro
    Dosage: 4 mg



Possible Neupro side effects in 29 year old female

Reported by a pharmacist from France on 2012-07-05

Patient: 29 year old female

Reactions: Pruritus, Application Site Swelling, Application Site Oedema, Aphonia

Drug(s) suspected as cause:
Neupro
    Start date: 2012-02-06
    End date: 2012-02-01

Neupro
    Dosage: progressively increased dose
    Start date: 2012-02-01
    End date: 2012-02-01

Neupro
    Indication: Parkinson's Disease
    Start date: 2012-02-01
    End date: 2012-04-13

Other drugs received by patient: Azilect



Possible Neupro side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-03

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Pruritus, Dermatitis, Application Site Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Neupro
    Indication: Parkinson's Disease
    Start date: 2011-06-01

Neupro
    Indication: Restless Legs Syndrome
    Start date: 2011-06-01

Other drugs received by patient: Ropinirol; Tilidin; Ropinirol; Tilidin; Clonazepam



Possible Neupro side effects in 76 year old female

Reported by a consumer/non-health professional from Germany on 2012-06-26

Patient: 76 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Pruritus, Application Site Pustules, Urticaria, Muscular Weakness, Skin Burning Sensation, Product Adhesion Issue, Erythema, Tremor, Medication Error, Gamma-Glutamyltransferase Increased, Alopecia, Hypertransaminasaemia

Drug(s) suspected as cause:
Neupro
    Indication: Parkinson's Disease
    Start date: 2012-04-01

Neupro
    Start date: 2012-04-10
    End date: 2012-04-25

Neupro
    Dosage: once daily at 06:00am
    Start date: 2012-03-10
    End date: 2012-01-01

Other drugs received by patient: Madopar; Novalgin; Madopar LT; Estradiol; Torsemide; Pantoprazole; Diovan; Omeprazole; Ergocalciferol; Metoprolol Tartrate; Aspirin; Diasporal Dinkt; Omega 3 KPS



Possible Neupro side effects in female

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

Patient: female

Reactions: Impulse-Control Disorder, Kleptomania, Pathological Gambling

Drug(s) suspected as cause:
Carbidopa and Levodopa
    Dosage: daily dose: 750 mg
    Administration route: Oral
    Indication: Parkinson's Disease

Madopar LT
    Dosage: 5x1
    Administration route: Oral
    Indication: Parkinson's Disease

Neupro
    Dosage: 8 mg/24 hour
    Indication: Parkinson's Disease

Requip
    Dosage: single dose 8
    Administration route: Oral
    Indication: Parkinson's Disease

Tasmar
    Administration route: Oral
    Indication: Parkinson's Disease

Other drugs received by patient: PK-Merz; Lactulose



Possible Neupro side effects in female

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

Patient: female

Reactions: Impulse-Control Disorder, Kleptomania, Pathological Gambling, Theft

Drug(s) suspected as cause:
Carbidopa and Levodopa
    Dosage: 125mg unknown
    Administration route: Oral
    Indication: Parkinson's Disease

Madopar
    Dosage: 125mg five times per day
    Administration route: Oral
    Indication: Parkinson's Disease

Neupro
    Dosage: 8mg per day
    Indication: Parkinson's Disease

Requip
    Dosage: 8mg three times per day
    Administration route: Oral
    Indication: Parkinson's Disease

Tasmar
    Dosage: 100mg three times per day
    Administration route: Oral
    Indication: Parkinson's Disease

Other drugs received by patient: Lactulose; L-Dopa; PK-Merz



Possible Neupro side effects in 74 year old male

Reported by a physician from Germany on 2012-06-14

Patient: 74 year old male, weighing 120.0 kg (264.0 pounds)

Reactions: Multi-Organ Failure, Cardiac Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupro
    Start date: 2006-12-11
    End date: 2008-11-11

Neupro
    Start date: 2008-11-12
    End date: 2008-11-26

Neupro
    Dosage: 1/2
    Indication: Parkinson's Disease
    Start date: 2006-11-27
    End date: 2006-12-10

Other drugs received by patient: Torsemide; PK Levo; PK Levo; Marcumar; Stalevo 100; Calcium Brause; Spiriva; Amlodipine; HCT Ratio; Allopurinol; Ramipril; PK Levo; Ramipril; Torsemide; Azilect; Pantoprazole; Ergocalciferol; Loftan; Bronchoretard



Possible Neupro side effects in 74 year old male

Reported by a physician from Germany on 2012-06-14

Patient: 74 year old male, weighing 120.0 kg (264.0 pounds)

Reactions: Cardiac Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Neupro
    Indication: Parkinson's Disease
    Start date: 2008-11-12
    End date: 2008-11-26

Neupro
    Start date: 2006-12-11
    End date: 2008-11-11

Neupro
    Dosage: 1/2 patch
    Start date: 2006-11-27
    End date: 2006-12-10

Other drugs received by patient: Ramipril; HCT Ratio; Azilect; Ergocalciferol; Torsemide; PK Levo; PK Levo; Amlodipine; Stalevo 100; Marcumar; PK Levo

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