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Sinemet CR (Carbidopa / Levodopa) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sinemet CR (Carbidopa / Levodopa) 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 (34)
Death (6)
Disability (5)

Reports by Reaction Type

Drug Ineffective (9)Overdose (6)Adverse Event (6)Parkinson's Disease (4)Product Quality Issue (4)Wrong Technique in Drug Usage Process (3)Fall (3)Abdominal Pain Upper (3)Death (3)Pneumonia Aspiration (2)Weight Increased (2)Intervertebral Disc Disorder (2)

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

Possible Sinemet CR side effects in

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

Patient:

Reactions: Product Quality Issue, Overdose, Parkinson's Disease, Adverse Event

Drug(s) suspected as cause:
Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2008-01-01

Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Start date: 2012-06-05

Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-06-01



Possible Sinemet CR side effects in

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient:

Reactions: Product Quality Issue, Overdose, Adverse Event, Parkinson's Disease

Drug(s) suspected as cause:
Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Start date: 2012-06-05

Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2008-01-01

Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-06-01



Possible Sinemet CR side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective, Feeling Abnormal

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in

Reported by a pharmacist from United Kingdom on 2012-08-22

Patient:

Reactions: Pneumonia Aspiration, Adverse Event

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in

Reported by a pharmacist from United Kingdom on 2012-07-28

Patient:

Reactions: Pneumonia Aspiration, Gastrointestinal Disorder

Drug(s) suspected as cause:
Sinemet
    Dosage: x 5 day
    Administration route: Oral

Sinemet CR
    Dosage: x 2 day
    Administration route: Oral



Possible Sinemet CR side effects in

Reported by a consumer/non-health professional from Canada on 2012-07-23

Patient:

Reactions: Product Quality Issue, Overdose, Adverse Event, Parkinson's Disease

Drug(s) suspected as cause:
Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-06-01

Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Start date: 2012-06-05

Sinemet CR
    Dosage: 50/200
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2008-01-01



Possible Sinemet CR side effects in

Reported by a consumer/non-health professional from Ireland on 2012-07-23

Patient:

Reactions: Lower Respiratory Tract Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Sinemet CR

Other drugs received by patient: Sinemet



Possible Sinemet CR side effects in

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient:

Reactions: Overdose, Arthralgia, Drug Ineffective, Feeling Jittery, Memory Impairment, Lethargy

Drug(s) suspected as cause:
Sinemet CR
    Dosage: 25/100mg, tid
    Administration route: Oral
    Start date: 2012-05-01
    End date: 2012-05-01

Sinemet CR
    Dosage: 25/250mg, q4h
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2012-05-01
    End date: 2012-05-01

Other drugs received by patient: Carisoprodol; Ibuprofen



Possible Sinemet CR side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-21

Patient: 81 year old male

Reactions: Phaeochromocytoma

Drug(s) suspected as cause:
Azilect
    Administration route: Oral
    Indication: Parkinsonism
    End date: 2012-04-02

Sinemet CR
    Administration route: Oral
    Indication: Parkinsonism
    Start date: 2011-01-01

Sinemet CR
    Administration route: Oral
    Start date: 2011-01-01

Other drugs received by patient: Omeprazole; Moviprep; Dihydroergotamine Mesylate; Acetaminophen; Midodrine Hydrochloride; Cymbalta; Lyrica



Possible Sinemet CR side effects in 60 year old female

Reported by a physician from United States on 2012-06-14

Patient: 60 year old female

Reactions: Vomiting, Nausea, Drug Ineffective, Abdominal Pain Upper, Insomnia, Depression, Asthenia, Decreased Appetite

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet
    Administration route: Oral
    Start date: 1989-01-01

Sinemet CR
    Administration route: Oral

Other drugs received by patient: Zoloft; Comtan; Melatonin; Diovan; Vitamins (Unspecified); Simvastatin; Omega-3 Marine Triglycerides; Clobetasol Propionate; Acetaminophen and Hydrocodone Bitartrate; Amantadine Hydrochloride; Pataday; Proair HFA



Possible Sinemet CR side effects in 64 year old male

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

Patient: 64 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Abdominal Discomfort, Product Substitution Issue, Drug Ineffective, Tablet Physical Issue

Drug(s) suspected as cause:
Sinemet CR
    Administration route: Oral

Sinemet CR
    Administration route: Oral

Other drugs received by patient: Hydromorphone; Clonazepam; Zopiclone; Quetiapine Fumarate; Testosterone



Possible Sinemet CR side effects in female

Reported by a consumer/non-health professional from South Africa on 2012-05-31

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: female

Reactions: Urticaria, Parkinson's Disease, Rash

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in 79 year old male

Reported by a physician from United States on 2012-05-18

Patient: 79 year old male, weighing 76.0 kg (167.2 pounds)

Reactions: Wrong Technique in Drug Usage Process, Overdose, Drug Ineffective, Feeling Abnormal, Disability, Nervousness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet CR

Other drugs received by patient: Amantadine Hydrochloride; Ropinirole; Selegiline



Possible Sinemet CR side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18

Patient: 79 year old male, weighing 76.2 kg (167.6 pounds)

Reactions: Weight Decreased, Product Quality Issue, Drug Ineffective, Fall, Tremor, Blood Pressure Fluctuation, Nervousness, Decreased Appetite

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Weight Increased, Intervertebral Disc Disorder, Blindness Unilateral, Arthritis, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR

Other drugs received by patient: Micardis; Hydrochlorothiazide



Possible Sinemet CR side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Weight Increased, Intervertebral Disc Disorder, Blindness Unilateral, Fall, Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR

Other drugs received by patient: Micardis; Hydrochlorothiazide



Possible Sinemet CR side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-15

Patient: 69 year old female

Reactions: Completed Suicide, Drug Withdrawal Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Comtan
    Administration route: Oral
    Start date: 2010-10-26

Sinemet
    Administration route: Oral
    Start date: 2009-01-01

Sinemet CR
    Administration route: Oral
    Start date: 2008-09-03

Trivastal
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2011-10-13



Possible Sinemet CR side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-05

Patient: 64 year old female

Reactions: Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in 65 year old male

Reported by a pharmacist from Canada on 2012-02-13

Patient: 65 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Overdose, Drug Ineffective, Dyskinesia, Disability, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet CR
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2009-11-01
    End date: 2011-07-01

Sinemet CR
    Dosage: half tablet
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-01

Sinemet CR
    Administration route: Oral
    Start date: 2011-08-01

Sinemet CR
    Administration route: Oral
    Start date: 2008-01-01



Possible Sinemet CR side effects in 64 year old male

Reported by a pharmacist from Canada on 2012-02-10

Patient: 64 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Abdominal Discomfort, Drug Ineffective

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet CR
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2011-10-01

Sinemet CR
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2010-07-19
    End date: 2011-10-19

Other drugs received by patient: Hydromorphone; Clonazepam; Hydromorphone; Clonazepam; Zopiclone



Possible Sinemet CR side effects in 84 year old female

Reported by a pharmacist from Canada on 2012-02-01

Patient: 84 year old female

Reactions: Dysphagia, Wrong Technique in Drug Usage Process, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-01-30

Patient: 84 year old female

Reactions: Extrapyramidal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR

Other drugs received by patient: Rabeprazole Sodium; Amiloride Hydrochloride and Hydrochlorothiazide; Lacidipine; Ticlopidine Hydrochloride; Domperidone; Potassium Chloride; Nutritional Supplements



Possible Sinemet CR side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-01-18

Patient: 84 year old female

Reactions: Extrapyramidal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR

Other drugs received by patient: Lacidipine; Rabeprazole Sodium; Potassium Chloride; Ticlopidine Hydrochloride; Domperidone; Amiloride Hydrochloride and Hydrochlorothiazide



Possible Sinemet CR side effects in 84 year old female

Reported by a pharmacist from Canada on 2012-01-13

Patient: 84 year old female

Reactions: Wrong Technique in Drug Usage Process, Dysphagia, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-27

Patient: 64 year old female

Reactions: Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-20

Patient: female

Reactions: Drug Ineffective, Product Physical Issue

Drug(s) suspected as cause:
Sinemet CR



Possible Sinemet CR side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-20

Patient: 31 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Citalopram
    Administration route: Oral

Diazepam

Gabapentin

Lorazepam

Oxycodone HCL and Acetaminophen
    Administration route: Oral

Sinemet CR
    Administration route: Oral

Wellbutrin XL



Possible Sinemet CR side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2011-11-30

Patient: 78 year old female

Reactions: Dysarthria, Hemiparesis, Suicidal Ideation

Drug(s) suspected as cause:
Memantine Hydrochloride
    Administration route: Oral
    Indication: Dementia With Lewy Bodies
    Start date: 2011-05-01
    End date: 2011-07-01

Sinemet CR
    Administration route: Oral
    Indication: Parkinson's Disease

Other drugs received by patient: Aspirin; Omeprazole; Metformin Hydrochloride; Enalapril Maleate



Possible Sinemet CR side effects in 90 year old

Reported by a consumer/non-health professional from United Kingdom on 2011-10-27

Patient: 90 year old

Reactions: Death, Off Label Use, Accidental Exposure

Adverse event resulted in: death

Drug(s) suspected as cause:
Sinemet CR

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