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: 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 2012-08-23
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 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 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
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: Drug Dose Omission, NO Adverse Event, Product Colour Issue
Drug(s) suspected as cause:
Janumet
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
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