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Ultracet (Tramadol / Acetaminophen) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (13)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ultracet (Tramadol / Acetaminophen) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Ultracet side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-01

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Pantoprazole
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Fluvastatin
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Ultracet
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13

Escitalopram
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Tramadol HCL
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13



Possible Ultracet side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-31

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatinaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 400 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Pantoprazole
    Dosage: 40 mg
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Ultracet
    Dosage: 3 df
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13

Escitalopram
    Dosage: 5 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Fluvastatin
    Dosage: 80 mg
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Tramadol HCL
    Dosage: 150 mg
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13



Possible Ultracet side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-05-29

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Escitalopram
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Tramadol HCL
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Depakene
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Ultracet
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13

Pantoprazole
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Fluvastatin
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13



Possible Ultracet side effects in female

Reported by a consumer/non-health professional from China on 2012-05-22

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Vomiting, Unresponsive To Stimuli, Lethargy

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ultracet
    Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2011-05-10
    End date: 2011-05-10

Ultracet
    Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
    Administration route: Oral
    Indication: Pain in Extremity
    Start date: 2011-05-10
    End date: 2011-05-10



Possible Ultracet side effects in female

Reported by a consumer/non-health professional from China on 2012-05-18

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Vomiting, Unresponsive To Stimuli, Lethargy

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ultracet
    Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
    Administration route: Oral
    Indication: Pain in Extremity
    Start date: 2011-05-10
    End date: 2011-05-11

Ultracet
    Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2011-05-10
    End date: 2011-05-11



Possible Ultracet side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-18

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Escitalopram
    Dosage: 5 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Ultracet
    Dosage: 3 df
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13

Pantoprazole
    Dosage: 40 mg
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Tramadol Hydrochloride
    Dosage: 150 mg
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Depakene
    Dosage: 400 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Fluvastatin
    Dosage: 80 mg
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13



Possible Ultracet side effects in female

Reported by a consumer/non-health professional from China on 2012-05-18

Patient: female

Reactions: Cardiac Discomfort, Dizziness, Cold Sweat

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ultracet



Possible Ultracet side effects in male

Reported by a physician from China on 2012-05-02

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Dysstasia, Chest Discomfort, Body Temperature Increased, Muscle Twitching, Hyperhidrosis, Pallor, Cardiac Arrest, Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ultracet
    Dosage: one tablet 3 times daily
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2011-05-16
    End date: 2011-05-18

Ultracet
    Dosage: one tablet 3 times daily
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-05-16
    End date: 2011-05-18

Other drugs received by patient: Unknown Medication; Unknown Medication; Unknown Medication



Possible Ultracet side effects in female

Reported by a consumer/non-health professional from China on 2012-05-02

Patient: female

Reactions: Cardiac Discomfort, Dizziness, Cold Sweat

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ultracet



Possible Ultracet side effects in female

Reported by a consumer/non-health professional from China on 2012-05-02

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Vomiting, Unresponsive To Stimuli, Lethargy

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ultracet
    Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
    Administration route: Oral
    Indication: Pain in Extremity
    Start date: 2011-05-10
    End date: 2011-05-11

Ultracet
    Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2011-05-10
    End date: 2011-05-11



Possible Ultracet side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 59 year old male

Reactions: Blood Bilirubin Increased, Confusional State, Blood Creatine Phosphokinase Increased, Drug Screen Positive, Mental Status Changes, Prothrombin Time Prolonged, Somnolence, Liver Function Test Abnormal, International Normalised Ratio Decreased, Multiple Drug Overdose, Blood Creatinine Increased, Blood Urea Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Toxicity To Various Agents, Dysarthria, Aspartate Aminotransferase Increased, Ammonia Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Opiates
    Indication: Product Used FOR Unknown Indication

Vicodin
    Indication: Pain

Ultracet
    Indication: Pain

Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication



Possible Ultracet side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 17 year old female

Reactions: Electrocardiogram QT Prolonged, Blood Potassium Decreased, Toxicity To Various Agents, Multiple Drug Overdose, Respiratory Depression, Sinus Tachycardia, Somnolence

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ultracet
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-29

Cyclobenzaprine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-29

Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-29

Phencyclidine
    Indication: Product Used FOR Unknown Indication

Opiates
    Indication: Product Used FOR Unknown Indication

Acetaminophen
    Administration route: Oral

Acetaminophen W / Codeine TAB
    Indication: Product Used FOR Unknown Indication

Methadone HCL
    Indication: Product Used FOR Unknown Indication



Possible Ultracet side effects in 66 year old male

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

Patient: 66 year old male

Reactions: Respiratory Failure, Suicide Attempt, Multiple Drug Overdose, Somnolence

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication

Ultracet
    Indication: Product Used FOR Unknown Indication

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