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Tramadol (Tramadol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tramadol 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 (5)

Reports by Reaction Type

Pneumonia Aspiration (1)Autoimmune Hepatitis (1)Pain (1)Urticaria (1)Hemiparesis (1)Pyrexia (1)Respiratory Depression (1)Suicidal Ideation (1)Neuropathy Peripheral (1)Sedation (1)Anger (1)Dyspnoea (1)

Possible Tramadol side effects in female

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

Patient: female

Reactions: Agranulocytosis, Hemisensory Neglect, Pyrexia, Hemiparesis, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 g, 3 to 4 times a day
    Start date: 2012-05-15

Lovenox
    Dosage: 4000 iu, daily
    Indication: Phlebitis
    Start date: 2012-05-15

Tramadol
    Dosage: 1 df, bid
    Administration route: Oral
    Start date: 2012-05-15

Perindopril Erbumine
    Dosage: 1 df, qd
    Indication: Hypertension
    Start date: 2012-06-01
    End date: 2012-06-06

Nicardipine HCL
    Start date: 2012-05-15

Nicardipine HCL
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2012-06-01

Other drugs received by patient: Crestor; Megareal; Levocarnil; Propranolol



Possible Tramadol side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 63 year old male

Reactions: Drug Effect Decreased, Pain in Extremity, Pain, Suicidal Ideation, Limb Discomfort, Neuropathy Peripheral, Activities of Daily Living Impaired, Anger, Gait Disturbance, Withdrawal Syndrome

Drug(s) suspected as cause:
Lyrica
    Dosage: 225 mg, 3x/day
    Administration route: Oral
    Indication: Pain

Neurontin
    Dosage: 300 mg, 3x/day
    Indication: Pain

Lyrica
    Indication: Hearing Impaired

Neurontin
    Dosage: unk
    Indication: Hearing Impaired

Neurontin

Tramadol
    Dosage: 100 mg, 3x/day

Neurontin
    Dosage: unk
    Indication: Neuropathy Peripheral

Lyrica
    Dosage: 75 mg, 3x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral

Lyrica
    Dosage: unk



Possible Tramadol side effects in 46 year old male

Reported by a physician from Korea, Republic of on 2012-04-27

Patient: 46 year old male

Reactions: Dysarthria, Pneumonia Aspiration, Sedation, Respiratory Depression

Drug(s) suspected as cause:
Morphine Sulfate
    Dosage: concentration of 28mg/ml,basal rate of 0.5 ml/h
    Indication: Pain

Tramadol
    Dosage: 50 mg, unk
    Indication: Pain



Possible Tramadol side effects in 58 year old male

Reported by a physician from Netherlands on 2012-04-16

Patient: 58 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: LIP Swelling, Malaise, Dyspnoea, Urticaria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pantoprazole
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2011-01-01

Tamsulosin Hydrochloride
    Dosage: 0.4 mg, 1x/day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2011-01-01

Tramadol
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Indication: Myalgia
    Start date: 2011-01-01
    End date: 2012-02-01

Arthrotec
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Myalgia
    Start date: 2011-01-01
    End date: 2012-03-03



Possible Tramadol side effects in 24 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-29

Patient: 24 year old male

Reactions: Jaundice, Autoimmune Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tramadol
    Dosage: unk
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Tetrazepam
    Dosage: unk
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

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