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Janumet (Sitagliptin / Metformin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Janumet (Sitagliptin / Metformin) 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 (430)
Death (33)
Life Threatening Events (52)
Disability (49)

Reports by Reaction Type

Pancreatitis (26)Diarrhoea (24)Weight Decreased (21)Lactic Acidosis (20)Pancreatic Carcinoma (19)Nausea (18)Renal Failure (18)Inappropriate Schedule of Drug Administration (16)Malaise (15)Lipase Increased (15)Confusional State (14)Pruritus (14)

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

Possible Janumet side effects in 34 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 34 year old male, weighing 98.0 kg (215.5 pounds)

Reactions: Weight Decreased, Malaise, Diarrhoea, Hyperhidrosis, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Tricor



Possible Janumet side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Pancreaticoduodenectomy, Pancreatic Carcinoma, Retroperitoneal Fibrosis, Hyperglycaemia, Cholecystitis Chronic, Gastrointestinal Tube Insertion, Haemoglobin Decreased, Malignant Neoplasm of Ampulla of Vater, Surgery, Intraductal Papillary Mucinous Neoplasm, Ileus, Pancreatitis Necrotising, Thrombocytosis, Pancreatitis, Cholecystectomy, Adrenal Mass

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Glucophage
    Dosage: 1000 mg, bid

Janumet
    Dosage: 100/2000
    Administration route: Oral

Janumet
    Dosage: 50/1000
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-06-01
    End date: 2010-12-07

Januvia
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-02-09
    End date: 2009-06-01

Prinivil
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: Hypertension
    End date: 2010-12-07

Other drugs received by patient: Flomax; Niaspan; Omega-3-Acid Ethyl Esters; Zetia; Crestor; Norvasc; Aspirin; Crestor; Nexium; Krill OIL



Possible Janumet side effects in 34 year old male

Reported by a physician from United States on 2012-08-24

Patient: 34 year old male, weighing 98.0 kg (215.5 pounds)

Reactions: Malaise, Diarrhoea, Hyperhidrosis, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Tricor



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Nephrolithiasis, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet
    Dosage: 500mg/50 mg, qd
    Administration route: Oral

Janumet
    Dosage: 500mg/50 mg, bid
    Administration route: Oral
    Indication: Diabetes Mellitus

Other drugs received by patient: Aspirin; Premarin; Lisinopril; Trilipix; Vitamin D



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Lipase Increased

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Coumadin; Lipira; Fosinopril Sodium; Metoprolol Tartrate



Possible Janumet side effects in

Reported by a physician from Spain on 2012-08-23

Patient:

Reactions: Vomiting, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient possibly interacting with the suspect drug:
Olmesartan Medoxomil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-09-21
    End date: 2010-10-07



Possible Janumet side effects in

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

Patient:

Reactions: Carbohydrate Antigen 19-9 Increased

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Paxil; Loratine; Geodon; Lipitor; Levemir; Glipizide; Meloxicam



Possible Janumet side effects in

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

Patient:

Reactions: Hyponatraemia, Headache, Constipation, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Irbesartan and Hydrochlorothiazide
    Dosage: 1 df, qd
    Administration route: Oral
    End date: 2012-07-06

Janumet
    Dosage: 1 df, bid
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-07
    End date: 2012-07-07

Other drugs received by patient: Amlodipine Besylate; Zocor



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Abdominal Discomfort

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Toprol-XL



Possible Janumet side effects in

Reported by a physician from Greece on 2012-08-23

Patient:

Reactions: Pemphigoid

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Quinapril Hydrochloride; Sertraline Hydrochloride; Cyanocobalamin (+) Pyridoxine (+) Thiamine; Hydrochlorothiazide



Possible Janumet side effects in

Reported by a consumer/non-health professional from Germany on 2012-08-23

Patient:

Reactions: Dyspnoea, Atrial Fibrillation, Bronchitis, Generalised Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-25

Janumet
    Dosage: unk
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2012-03-01

Other drugs received by patient: Aspirin; Torsemide; Pantoprazole; NAC Diagnostic Reagent; Falithrom; Amlodipine; Digitoxin TAB; Metoprolol Tartrate



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 Greece on 2012-08-23

Patient:

Reactions: Pemphigoid

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Hydrochlorothiazide; Accuretic; Zoloft; Neurobion



Possible Janumet side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient:

Reactions: Diarrhoea

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Furosemide; Klor-CON; Metoprolol Tartrate



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Diarrhoea, Dizziness, Abdominal Distension

Drug(s) suspected as cause:
Janumet
    Dosage: unk
    Administration route: Oral
    Indication: Diabetes Mellitus

Janumet XR
    Dosage: 50/1000mg, 2 tablets at bedtime
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-06-24
    End date: 2012-07-01



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

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

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



Possible Janumet side effects in

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

Patient:

Reactions: Diarrhoea

Drug(s) suspected as cause:
Janumet



Possible Janumet side effects in

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

Patient:

Reactions: Pemphigoid

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Cyanocobalamin (+) Pyridoxine (+) Thiamine; Hydrochlorothiazide; Quinapril Hydrochloride; Sertraline Hydrochloride



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Vomiting, Nausea

Drug(s) suspected as cause:
Janumet



Possible Janumet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Drug Intolerance

Drug(s) suspected as cause:
Janumet



Possible Janumet side effects in

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

Patient:

Reactions: Glycosylated Haemoglobin Increased, Sensation of Heaviness, Depression

Drug(s) suspected as cause:
Humalog
    Dosage: 15 units, before each meal

Janumet
    Dosage: 500mg/50mg, bid int he morning and at night
    Administration route: Oral

Lantus
    Dosage: 30 units, bid
    Indication: Diabetes Mellitus



Possible Janumet side effects in

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

Patient:

Reactions: Pancreatic Carcinoma

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

Drug(s) suspected as cause:
Janumet



Possible Janumet side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-08-22

Patient: 76 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Idiopathic Thrombocytopenic Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet
    Dosage: 2 tab, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-05-28

Repaglinide
    Dosage: 0.5 mg, bid
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-15

Other drugs received by patient: Fursemid / 00032601 /; Allopurinol; Lanitop



Possible Janumet side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Angioedema

Drug(s) suspected as cause:
Janumet
    Dosage: 50/500mg, bid
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2012-02-24
    End date: 2012-02-26

Janumet
    Indication: Diabetes Mellitus

Other drugs received by patient: Cozaar



Possible Janumet side effects in

Reported by a pharmacist from Ireland on 2012-08-14

Patient:

Reactions: Pancreatic Necrosis, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Janumet
    Dosage: 50mg/1000mg
    Administration route: Oral
    Indication: Diabetes Mellitus

Janumet
    Indication: Hypertension

Lansoprazole
    Dosage: 30 mg, unk

Ramipril
    Dosage: 10 mg, qd
    Administration route: Oral

Other drugs received by patient: Protelos; Gliclazide; Calcium Carbonate; Aspirin



Possible Janumet side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Incorrect Dose Administered, Drug Hypersensitivity, Rash, Eye Pruritus, Oropharyngeal Discomfort

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Diovan; Vitamins (Unspecified)



Possible Janumet side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient:

Reactions: Lipase Increased

Drug(s) suspected as cause:
Janumet
    Administration route: Oral
    Indication: Diabetes Mellitus

Januvia
    Administration route: Oral
    Indication: Diabetes Mellitus

Metformin Hydrochloride
    Indication: Diabetes Mellitus



Possible Janumet side effects in 60 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-13

Patient: 60 year old female, weighing 96.0 kg (211.2 pounds)

Reactions: Injection Site Haematoma, Cardiac Disorder

Drug(s) suspected as cause:
Janumet
    Start date: 2012-08-02

Lantus
    Indication: Type 2 Diabetes Mellitus
    Start date: 2004-01-01

Other drugs received by patient: Aspirin; Adalat; Crestor; Metformin Hydrochloride; Humalog; Benicar; Indapamide; Olcadil; Metoprolol Succinate; Plavix



Possible Janumet side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient:

Reactions: Fatigue, Somnolence

Drug(s) suspected as cause:
Janumet

Other drugs received by patient: Simvastatin

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