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Sinemet (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 (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 (150)
Death (11)
Disability (19)

Reports by Reaction Type

Overdose (15)Drug Ineffective (11)Dyskinesia (11)Fall (11)Parkinson's Disease (9)Hallucination (9)Off Label Use (8)Dizziness (8)Confusional State (7)Asthenia (7)Weight Decreased (6)Wrong Technique in Drug Usage Process (6)

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

Possible Sinemet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient:

Reactions: Dialysis

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

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

Patient:

Reactions: Eyelid Ptosis

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient:

Reactions: Wrong Technique in Drug Usage Process, Gallbladder Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

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

Patient:

Reactions: Dizziness

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in female

Reported by a physician from France on 2012-08-22

Patient: female

Reactions: Incorrect Dose Administered, Rotator Cuff Syndrome, Bursitis, Tendonitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Azilect
    Dosage: 1mg per day
    Administration route: Oral
    Indication: Parkinson's Disease

Requip
    Administration route: Oral
    Indication: Parkinson's Disease

Sinemet
    Dosage: 100mg three times per day
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-07-09



Possible Sinemet side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: female

Reactions: Bursitis, Tendonitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Azilect
    Dosage: 1 milligram daily; long term treatment
    Administration route: Oral
    Indication: Parkinson's Disease

Requip
    Dosage: 14 milligram daily; 6mg in the morning + 8mg in the evening
    Administration route: Oral

Requip
    Dosage: 14 milligram daily; 6mg in the morning + 8mg in the evening
    Administration route: Oral
    Indication: Parkinson's Disease

Sinemet
    Dosage: levodopa/carbidopa:100mg/10mg
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-07-09



Possible Sinemet side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-08-22

Patient:

Reactions: Gastrointestinal Surgery

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Somnolence

Drug(s) suspected as cause:
Mirapex
    Dosage: 1 df, qd

Sinemet
    Dosage: 2 df, bid
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2007-01-01

Other drugs received by patient: Simvastatin; Metformin; Diovan; Lidoderm; Prevacid; Vicodin; Levothyroxine Sodium; Cogentin



Possible Sinemet side effects in male

Reported by a physician from France on 2012-08-16

Patient: male

Reactions: Hallucination, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Requip
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-02-01

Sinemet
    Dosage: 50mg four times per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-01

Other drugs received by patient: Verapamil



Possible Sinemet side effects in 59 year old female

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

Patient: 59 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Therapeutic Response Decreased, Product Quality Issue, Wrong Technique in Drug Usage Process, Dyskinesia, Parkinson's Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet
    Dosage: 100/25
    Administration route: Oral
    Start date: 2000-01-01

Sinemet
    Dosage: 25-100
    Administration route: Oral

Sinemet
    Dosage: 25-100
    Administration route: Oral

Other drugs received by patient: Pramipexole Dihydrochloride



Possible Sinemet side effects in

Reported by a physician from United States on 2012-08-06

Patient:

Reactions: Muscular Weakness, Parkinson's Disease, Feeling Abnormal

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a pharmacist from United States on 2012-08-04

Patient:

Reactions: Dialysis

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-08-03

Patient:

Reactions: Gallbladder Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a consumer/non-health professional from United States on 2012-07-29

Patient:

Reactions: Tongue Injury, Tongue Biting, Dizziness, Asthenia, Feeling Abnormal, Muscle Spasms

Drug(s) suspected as cause:
Sinemet



Possible Sinemet 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 side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-07-25

Patient:

Reactions: Abnormal Dreams, Drug Dose Omission, Oedema Peripheral, Shoulder Arthroplasty, Dyskinesia, Hallucination, Fall, Deep Brain Stimulation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Morphine Sulfate

Sinemet
    Dosage: 3 df, tid
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 1999-07-01

Other drugs received by patient: Comtan; Lexapro; Lopid; Wellbutrin; Requip; Zoloft; Stalevo 100; Nexium



Possible Sinemet side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23

Patient:

Reactions: Weight Decreased, Overdose, Vomiting, Nausea, Dyskinesia

Adverse event resulted in: hospitalization

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

Sinemet
    Dosage: 8.5 df, qd
    Administration route: Oral
    Indication: Parkinson's Disease



Possible Sinemet side effects in

Reported by a pharmacist from United States on 2012-07-23

Patient:

Reactions: Overdose, NO Adverse Event

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient:

Reactions: Chest Discomfort, Dysphagia, Wrong Technique in Drug Usage Process, Tablet Physical Issue, Restless Legs Syndrome, Tremor, Paraesthesia, Overdose, Diarrhoea, Musculoskeletal Stiffness, Muscle Spasms

Drug(s) suspected as cause:
Sinemet

Other drugs received by patient: Evista



Possible Sinemet side effects in

Reported by a consumer/non-health professional from Sweden on 2012-07-12

Patient:

Reactions: Epilepsy

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-11

Patient:

Reactions: Dyspnoea, Oromandibular Dystonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet
    Dosage: 300mg-30
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-07

Sinemet
    Dosage: 300mg-30
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2009-01-01
    End date: 2012-06-01



Possible Sinemet side effects in 61 year old female

Reported by a pharmacist from Australia on 2012-07-02

Patient: 61 year old female

Reactions: Anxiety, Dyspnoea, Drug Ineffective, Palpitations, Muscle Twitching

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sinemet
    Dosage: new tablet
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2012-03-13
    End date: 2012-03-14

Sinemet
    Dosage: new tablet
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-14

Other drugs received by patient: Eutroxsig; Diazepam; Rabeprazole Sodium; Phenergan HCL; Temazepam; Cymbalta



Possible Sinemet side effects in 28 year old male

Reported by a pharmacist from Netherlands on 2012-06-29

Patient: 28 year old male

Reactions: Weight Decreased, Dyspnoea, Visual Impairment, Adverse Event, Mental Disorder

Drug(s) suspected as cause:
Remicade
    Start date: 2011-12-01
    End date: 2012-03-01

Remicade
    Indication: Colitis
    Start date: 2009-10-01
    End date: 2011-03-01

Sinemet
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Asacol; Paroxetine HCL; Risperidone



Possible Sinemet side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29

Patient: 73 year old male

Reactions: Movement Disorder, Overdose, Toxicity To Various Agents, Delirium, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in 9 year old male

Reported by a physician from United States on 2012-06-26

Patient: 9 year old male

Reactions: Ileus, Dehydration, Neuroleptic Malignant Syndrome, Pyrexia, Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet
    Administration route: Oral
    Start date: 2010-01-01

Sinemet
    Administration route: Oral
    Indication: Dystonia

Sinemet
    Administration route: Oral

Other drugs received by patient: Baclofen; Clonazepam



Possible Sinemet side effects in male

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

Patient: male

Reactions: Tardive Dyskinesia, Meningioma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozapine
    Dosage: 37.5 mg
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-02-01
    End date: 2012-01-06

Cymbalta
    Dosage: 1 df, unk
    Indication: Major Depression
    Start date: 2010-01-01
    End date: 2011-12-20

Sinemet
    Dosage: 3 df
    Start date: 2011-02-01
    End date: 2012-01-04

Other drugs received by patient: Metoprolol Tartrate; Aspirin; Ramipril; Novonorm



Possible Sinemet side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-19

Patient: male

Reactions: Flushing, Vision Blurred, Hypertension, Pseudophaeochromocytoma, Hyperhidrosis

Drug(s) suspected as cause:
Azilect
    Dosage: 1 milligram;
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-04-02

Sinemet
    Dosage: 100 mg/ 25 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2001-01-01

Sinemet
    Dosage: 200 mg/ 50 mg, daily: 800 mg/ 200 mg
    Administration route: Oral
    Start date: 2001-01-01

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



Possible Sinemet side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: 73 year old male

Reactions: Movement Disorder, Overdose, Toxicity To Various Agents, Delirium, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sinemet



Possible Sinemet side effects in 30 year old male

Reported by a physician from United States on 2012-06-15

Patient: 30 year old male

Reactions: Panic Attack, Sedation, Gait Disturbance, Fall

Drug(s) suspected as cause:
Risperidone
    Dosage: 0.5 mg, 1 d
    Indication: Chorea

Sinemet
    Indication: Product Used FOR Unknown Indication

Tetrabenazine (Tetrabenazine)
    Dosage: 25 mg (12.5 mg, 2 in 1 d)
    Indication: Product Used FOR Unknown Indication



Possible Sinemet 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

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