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Januvia (Sitagliptin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Januvia (Sitagliptin) 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 (1599)
Death (144)
Life Threatening Events (157)
Disability (94)

Reports by Reaction Type

Pancreatitis (192)Hypoglycaemia (93)Interstitial Lung Disease (67)Pancreatic Carcinoma (63)Blood Glucose Increased (58)Nausea (48)Diarrhoea (39)Pancreatitis Acute (35)Renal Failure (34)Renal Failure Acute (33)Abdominal Pain (31)Weight Decreased (31)

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

Possible Januvia side effects in female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-27

Patient: female

Reactions: Syncope, Chills, Headache, Treatment Noncompliance, Lower Respiratory Tract Infection, Feeling Cold, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprager
    Indication: Depression

Diamicron MR
    Indication: Blood Glucose

Januvia
    Indication: Blood Glucose

Rebif
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-07-18
    End date: 2012-02-06

Rebif
    Start date: 2012-03-01

Other drugs received by patient: Lopraz (Omeprazole); Fluticasone Propionate / Salmeterol; Epilin (Epilim); Florinef; Valproic Acid; Cardiac Medication



Possible Januvia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Pancreatitis

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Metformin HCL



Possible Januvia side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Pancreatitis

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Metformin HCL



Possible Januvia side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Nausea

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Metformin HCL; Metoprolol Tartrate; Lantus; Aspirin; Lisinopril; Ubidecarenone; Plavix Lantis; Omega-3-Acid Ethyl Esters



Possible Januvia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Plavix; Crestor; Glucophage; Lisinopril; Isosorbide; Glimepiride



Possible Januvia side effects in

Reported by a physician from United States on 2012-08-26

Patient:

Reactions: Pancreatitis

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Nausea, Muscular Weakness, Headache, Abdominal Pain Upper, Tremor, Blood Glucose Abnormal, Blood Glucose Decreased, Malaise, Heart Rate Increased, Dizziness, Adverse Event, Bladder Disorder, Coordination Abnormal, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actos
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-06-22

Amaryl
    Dosage: 2 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-21
    End date: 2012-06-22

Januvia
    Dosage: unk
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-06-22

Other drugs received by patient: Temazepam; Lipitor; Tricor; Diovan; Lopressor



Possible Januvia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Weight Decreased, Swelling, Pancreatitis

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

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

Patient:

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-24

Patient:

Reactions: Ammonia Increased, Lactic Acidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Raloxifene Hydrochloride; Vitamin B12; Alfarol



Possible Januvia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Overdose, Renal Failure

Drug(s) suspected as cause:
Januvia
    Dosage: 100 mg, bid
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Januvia
    Dosage: 50 mg, qd
    Administration route: Oral

Other drugs received by patient: Metformin HCL



Possible Januvia side effects in

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

Patient:

Reactions: Tubulointerstitial Nephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actos
    Dosage: 7.5 mg, qd
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2011-01-01
    End date: 2011-03-01

Candesartan Cilexetil
    Dosage: 8 mg, qd
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 2010-06-01
    End date: 2011-04-01

Januvia
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2010-09-01
    End date: 2011-03-01

Metformin HCL
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2010-11-01
    End date: 2011-01-01

Micardis
    Dosage: 80 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-06-01



Possible Januvia 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 Januvia side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-24

Patient:

Reactions: Musculoskeletal Pain

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Kinedak; Glimicron; Metformin HCL; Micardis; Ferrous Citrate; Glucobay; Livalo; Pursennid (Sennosides); Aspirin



Possible Januvia side effects in

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

Patient:

Reactions: Fatigue

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Crestor; Lisinopril; Metformin HCL; Glipizide; Lasix



Possible Januvia side effects in

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

Patient:

Reactions: Adenocarcinoma Pancreas

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Quetiapine Fumarate; Furosemide; Gliclazide; Valproic Acid; Bisoprolol Fumarate; Metformin; Haloperidol



Possible Januvia side effects in

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

Patient:

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Valproate Sodium



Possible Januvia side effects in

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

Patient:

Reactions: Hypoaesthesia Oral, Ageusia

Drug(s) suspected as cause:
Januvia
    Dosage: unk df, unk
    Administration route: Oral

Metformin HCL



Possible Januvia side effects in

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

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Diovan; Lipitor; Plavix



Possible Januvia side effects in

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

Patient:

Reactions: Blood Glucose Abnormal

Drug(s) suspected as cause:
Glimepiride
    Indication: Type 2 Diabetes Mellitus

Januvia
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus



Possible Januvia side effects in

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

Patient:

Reactions: Angioedema

Drug(s) suspected as cause:
Januvia

Other drugs received by patient: Losartan Potassium



Possible Januvia side effects in

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

Patient:

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

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

Patient:

Reactions: Death, Neoplasm

Adverse event resulted in: death

Drug(s) suspected as cause:
Diamicron
    Dosage: 30 mg, qd
    Administration route: Oral
    Start date: 2011-09-23
    End date: 2012-01-16

Januvia
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-09-23
    End date: 2012-01-16

Lantus

Lantus
    Dosage: 32 iu, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-09-23
    End date: 2012-01-16

Metformin HCL
    Dosage: 700 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-09-23
    End date: 2012-01-16

Metformin HCL
    Dosage: 1000 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-02-01
    End date: 2011-09-23

Metformin Hydrochloride
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2011-01-16

Metformin Hydrochloride
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-09-29
    End date: 2011-09-23

Repaglinide
    Dosage: 6 mg, qd
    Administration route: Oral
    Start date: 2012-01-16

Repaglinide
    Dosage: 12 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-05-28
    End date: 2011-09-23

Sitagliptin Phosphate / Metformin Hydrochloride
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-02-01
    End date: 2010-09-29



Possible Januvia side effects in

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

Patient:

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

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

Patient:

Reactions: Pancreatitis, Underdose

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

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

Patient:

Reactions: Hysterectomy, Postoperative Wound Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

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

Patient:

Reactions: Microcytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2011-02-02
    End date: 2011-02-15

Januvia
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-02-16

Other drugs received by patient: Glimicron; Abilify; Clonazepam; Tasmolin (Biperiden); Cymbalta; Desyrel; Lorazepam; Livalo; Metformin HCL



Possible Januvia side effects in

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

Patient:

Reactions: Eye Swelling

Drug(s) suspected as cause:
Januvia



Possible Januvia side effects in

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

Patient:

Reactions: Product Quality Issue, Intestinal Operation, Liver Operation, Rhinorrhoea, Blood Glucose Increased, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Januvia
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2012-07-20

Januvia
    Dosage: 50 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2006-12-03

Other drugs received by patient: Nexium; Cholecalciferol; Actos; Benicar; Zetia; Aspirin; Aspirin; Amaryl; Tylenol; Prozac; Omega-3-Acid Ethyl Esters; Fibercon



Possible Januvia side effects in

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

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Januvia

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