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Janumet (Sitagliptin / Metformin) - Lactic Acidosis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Lactic Acidosis (20)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Janumet (Sitagliptin / Metformin) where reactions include lactic acidosis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Janumet side effects in

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

Patient:

Reactions: Torsade DE Pointes, Hyperkalaemia, Lactic Acidosis, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Janumet
    Dosage: 100mg-2000
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-07-16

Janumet

Ketoprofen
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2012-07-12
    End date: 2012-07-14

Ketoprofen
    Dosage: unk
    Indication: Sciatica
    Start date: 2012-07-10
    End date: 2012-07-11

Telmisartan
    Dosage: 80 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-07-16

Celiprolol Hydrochloride
    Dosage: 200 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-07-16

Other drugs received by patient: Crestor; Tramadol Hydrochloride; Aspirin; Acetaminophen; Morphine Sulfate; Metformin Hydrochloride



Possible Janumet side effects in

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

Patient:

Reactions: Lactic Acidosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Atarax; Acetaminophen; Perindopril Erbumine; Previscan; Bisoprolol Fumarate; Lasix; Simvastatin; Ferrous Sulfate TAB



Possible Janumet side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient:

Reactions: Rhabdomyolysis, Anaemia, Hepatic Failure, Lactic Acidosis, Factor V Deficiency, Multi-Organ Failure, Renal Failure, Escherichia Test Positive, Thrombocytopenia

Adverse event resulted in: life threatening event, hospitalization

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

Janumet
    Administration route: Oral

Pegasys

Telaprevir
    Administration route: Oral



Possible Janumet side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-05

Patient: 58 year old female

Reactions: Hypothermia, Lactic Acidosis, Diabetic Hyperosmolar Coma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Hydrochlorothiazide and Olmesartan Medoxomil; Repaglinide



Possible Janumet side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-08

Patient: 56 year old male, weighing 49.0 kg (107.8 pounds)

Reactions: Multi-Organ Failure, Rhabdomyolysis, Lactic Acidosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Peginterferon Alfa-2A
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-04-10

Telaprevir
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Other drugs received by patient: Epoetin Beta



Possible Janumet side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-01

Patient: 56 year old male, weighing 49.0 kg (107.8 pounds)

Reactions: Multi-Organ Failure, Rhabdomyolysis, Lactic Acidosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-04-10

Telaprevir
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Peginterferon Alfa-2A
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Other drugs received by patient: Epoetin Beta



Possible Janumet side effects in male

Reported by a physician from France on 2012-05-01

Patient: male, weighing 49.0 kg (107.8 pounds)

Reactions: Rhabdomyolysis, Anaemia, Hepatic Failure, Lactic Acidosis, Factor V Deficiency, Multi-Organ Failure, Renal Failure, Escherichia Test Positive, Thrombocytopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Incivo
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-24
    End date: 2012-04-10

Pegasys
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-24
    End date: 2012-04-10

Copegus
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-24

Copegus

Janumet
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-10



Possible Janumet side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-30

Patient: 56 year old male, weighing 49.0 kg (107.8 pounds)

Reactions: Multi-Organ Failure, Rhabdomyolysis, Lactic Acidosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Peginterferon Alfa-2A
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-04-10

Telaprevir
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-10

Other drugs received by patient: Epoetin Beta



Possible Janumet side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-10

Patient: 75 year old female

Reactions: Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Zolpidem Tartrate; Verapamil Hydrochloride; Fluindione; Bromazepam; Venlafaxine Hydrochloride; Etifoxine Hydrochloride; Desloratadine; Gliclazide; Atenolol; Levothyroxine Sodium; Zocor; Furosemide; Bevacizumab and Paclitaxel



Possible Janumet side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-09

Patient: 47 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Renal Failure, Pancreatitis Necrotising, Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ramipril
    Administration route: Oral
    Start date: 2011-09-01
    End date: 2011-12-25

Irbesartan + Hydrochlorothiazide
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-09-01
    End date: 2011-12-25

Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-01-01
    End date: 2011-12-25

Other drugs received by patient: Insulin; Aspirin and Clopidogrel Bisulfate; Bisoprolol Fumarate



Possible Janumet side effects in 47 year old male

Reported by a consumer/non-health professional from France on 2012-04-04

Patient: 47 year old male

Reactions: Renal Failure, Oedematous Pancreatitis, Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Irbesartan and Hydrochlorothiazide
    Dosage: 1df:300mg/12.5mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-09-01
    End date: 2011-12-25

Janumet
    Dosage: 1df:50mg/1000mg
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-01-01
    End date: 2011-12-25

Ramipril
    Administration route: Oral
    Start date: 2011-09-01
    End date: 2011-12-25

Other drugs received by patient: Bisoprolol Fumarate; Insulin; Clopidogrel Bisulfate and Aspirin



Possible Janumet side effects in 47 year old male

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

Patient: 47 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Multi-Organ Failure, Renal Failure, Pancreatitis Necrotising, Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hydrochlorothiazide
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-09-01
    End date: 2011-12-25

Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-01-01
    End date: 2011-12-25

Ramipril
    Administration route: Oral
    Start date: 2011-09-01
    End date: 2011-12-25

Other drugs received by patient: Aspirin and Clopidogrel Bisulfate; Insulin; Bisoprolol Fumarate



Possible Janumet side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-02

Patient: 75 year old female

Reactions: Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Zolpidem Tartrate; Venlafaxine Hydrochloride; Verapamil Hydrochloride; Zocor; Gliclazide; Fluindione; Levothyroxine Sodium; Bromazepam; Desloratadine; Bevacizumab and Paclitaxel; Atenolol; Furosemide; Etifoxine Hydrochloride



Possible Janumet side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: 52 year old female, weighing 83.9 kg (184.6 pounds)

Reactions: Confusional State, Metamorphopsia, Impaired Work Ability, Disorientation, Lactic Acidosis, Headache, Loss of Consciousness, Abdominal Discomfort, Pancreatic Disorder, Malaise, Dizziness, Heart Rate Irregular, Protein Urine Present, Vulvovaginal Discomfort, Diarrhoea, Dehydration, Asthenia

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Janumet



Possible Janumet side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-07

Patient: 79 year old male

Reactions: Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-02

Metformin Hydrochloride
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-02

Other drugs received by patient: Tramadol Hydrochloride; Guaifenesin and Oxomemazine and Sodium Benzoate; Clopidogrel Bisulfate



Possible Janumet side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-27

Patient: 79 year old male

Reactions: Lactic Acidosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-02

Metformin Hydrochloride
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-02

Other drugs received by patient: Guaifenesin and Oxomemazine and Sodium Benzoate; Tramadol Hydrochloride; Clopidogrel Bisulfate



Possible Janumet side effects in 70 year old male

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

Patient: 70 year old male, weighing 76.0 kg (167.2 pounds)

Reactions: Portal Vein Thrombosis, Hyperglycaemia, Hypotension, Cytolytic Hepatitis, Tachycardia, Pancreatic Cyst, Hepatic Failure, Cholestasis, Tumour Compression, Lactic Acidosis, Hepatitis, Haemodynamic Instability, Renal Failure, Bile Duct Stenosis, Biliary Dilatation, Abdominal Sepsis, Gastric Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia
    Administration route: Oral
    Indication: Pancreatogenous Diabetes
    Start date: 2011-09-19
    End date: 2011-10-07

Janumet
    Administration route: Oral
    Indication: Pancreatogenous Diabetes
    Start date: 2011-06-23
    End date: 2011-09-19

Other drugs received by patient: Aspirin and Pravastatin Sodium; SAW Palmetto; Irbesartan; Pancreatin; Repaglinide



Possible Janumet side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-22

Patient: 71 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Dyspnoea, Dyspnoea Exertional, Pneumonia, Hypophagia, Lung Infection, Lactic Acidosis, Fall, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Norvasc



Possible Janumet side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-21

Patient: 77 year old male

Reactions: Hyperkalaemia, Lactic Acidosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Hydrochlorothiazide and Irbesartan; Ciprofloxacin Hydrochloride; Fluindione; Nebivolol; Ferrous Sulfate



Possible Janumet side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-07

Patient: 77 year old male

Reactions: Electrocardiogram QRS Complex Prolonged, Hyperkalaemia, General Physical Health Deterioration, Lactic Acidosis, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Hydrochlorothiazide and Irbesartan; Ferrous Sulfate; Ciprofloxacin Hydrochloride; Fluindione; Nebivolol

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