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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