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JANUVIA

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Januvia Adverse Events Reported to the FDA Over Time

How are Januvia adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Januvia, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Januvia is flagged as the suspect drug causing the adverse event.

Most Common Januvia Adverse Events Reported to the FDA

What are the most common Januvia adverse events reported to the FDA?

Blood Glucose Increased
963 (3.23%)
Pancreatitis
834 (2.79%)
Hypoglycaemia
753 (2.52%)
Drug Ineffective
663 (2.22%)
Headache
608 (2.04%)
Nausea
588 (1.97%)
Rash
473 (1.58%)
Diarrhoea
445 (1.49%)
Dizziness
396 (1.33%)
Weight Decreased
321 (1.08%)
Wrong Technique In Drug Usage Proce...
315 (1.06%)
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Oedema Peripheral
300 (1%)
Vomiting
282 (.94%)
Renal Failure Acute
281 (.94%)
Rhinorrhoea
269 (.9%)
Dyspnoea
268 (.9%)
Pruritus
246 (.82%)
Constipation
225 (.75%)
Fatigue
225 (.75%)
Malaise
212 (.71%)
Cough
209 (.7%)
Glycosylated Haemoglobin Increased
209 (.7%)
Asthenia
194 (.65%)
Renal Failure
193 (.65%)
Myalgia
192 (.64%)
Weight Increased
191 (.64%)
Arthralgia
190 (.64%)
Blood Glucose Decreased
190 (.64%)
Abdominal Pain
185 (.62%)
Abdominal Pain Upper
185 (.62%)
Blood Creatinine Increased
184 (.62%)
Pancreatitis Acute
184 (.62%)
Upper Respiratory Tract Infection
167 (.56%)
Interstitial Lung Disease
159 (.53%)
Pain In Extremity
156 (.52%)
Nasal Congestion
145 (.49%)
Pancreatic Carcinoma
139 (.47%)
Decreased Appetite
138 (.46%)
Adverse Event
136 (.46%)
Death
136 (.46%)
Oedema
133 (.45%)
Urticaria
130 (.44%)
Cerebrovascular Accident
129 (.43%)
Overdose
128 (.43%)
Pain
123 (.41%)
Back Pain
122 (.41%)
Chest Pain
121 (.41%)
Pneumonia
118 (.4%)
Vision Blurred
118 (.4%)
Lipase Increased
115 (.39%)
Alanine Aminotransferase Increased
113 (.38%)
Feeling Abnormal
113 (.38%)
Myocardial Infarction
113 (.38%)
Pyrexia
113 (.38%)
Rash Pruritic
113 (.38%)
Cardiac Failure Congestive
112 (.38%)
Oropharyngeal Pain
112 (.38%)
Blood Glucose Abnormal
108 (.36%)
Hepatic Enzyme Increased
107 (.36%)
Aspartate Aminotransferase Increase...
106 (.36%)
Abdominal Distension
105 (.35%)
Hyperglycaemia
105 (.35%)
Liver Disorder
105 (.35%)
Renal Impairment
101 (.34%)
Tremor
101 (.34%)
Dyspepsia
100 (.33%)
Angioedema
99 (.33%)
Inappropriate Schedule Of Drug Admi...
98 (.33%)
Cardiac Failure
94 (.31%)
Drug Interaction
93 (.31%)
Insomnia
92 (.31%)
Palpitations
91 (.3%)
Fall
90 (.3%)
Loss Of Consciousness
90 (.3%)
Rhabdomyolysis
90 (.3%)
Abdominal Discomfort
88 (.29%)
Swelling Face
87 (.29%)
Hyperhidrosis
86 (.29%)
Muscular Weakness
86 (.29%)
Rash Generalised
86 (.29%)
Dysphagia
84 (.28%)
Erythema
84 (.28%)
Nasopharyngitis
84 (.28%)
Diabetes Mellitus Inadequate Contro...
82 (.27%)
Gastrointestinal Disorder
82 (.27%)
Alopecia
81 (.27%)
Dehydration
80 (.27%)
Hepatitis
79 (.26%)
Joint Swelling
76 (.25%)
Muscle Spasms
76 (.25%)
Paraesthesia
76 (.25%)
Hypersensitivity
74 (.25%)
Lip Swelling
71 (.24%)
Gastrooesophageal Reflux Disease
70 (.23%)
Hyperkalaemia
69 (.23%)
Somnolence
69 (.23%)
Anaemia
68 (.23%)
Hepatic Function Abnormal
65 (.22%)
Anxiety
64 (.21%)
Renal Disorder
64 (.21%)
Depression
63 (.21%)

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This graph shows the top adverse events submitted to the FDA for Januvia, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Januvia is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Januvia

What are the most common Januvia adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Januvia, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Januvia is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Januvia According to Those Reporting Adverse Events

Why are people taking Januvia, according to those reporting adverse events to the FDA?

Diabetes Mellitus
5614
Type 2 Diabetes Mellitus
5022
Diabetes Mellitus Non-insulin-depen...
645
Product Used For Unknown Indication
388
Blood Glucose
273
Drug Use For Unknown Indication
174
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Blood Glucose Increased
100
Blood Glucose Abnormal
78
Hyperglycaemia
75
Diabetes Mellitus Inadequate Contro...
45
Type 1 Diabetes Mellitus
41
Glycosylated Haemoglobin Increased
29
Insulin-requiring Type 2 Diabetes M...
21
Glucose Tolerance Impaired
19
Hypertension
7
Diabetes Mellitus Insulin-dependent
7
Pancreatogenous Diabetes
6
Glycosylated Haemoglobin
5
Obesity
4
Diabetes Mellitus Management
4
Blood Glucose Fluctuation
4
Hypoglycaemia
4
Gestational Diabetes
3
Insulin Resistance
3
Drug Therapy
3
Pain
3
Ill-defined Disorder
3
Polycystic Ovaries
3
Blood Glucose Decreased
3
Intentional Drug Misuse
2
Weight Decreased
2
Pancreatic Disorder
2
Constipation
2
Impaired Fasting Glucose
2
Renal Failure
2
Polyuria
2
Essential Hypertension
2
Diverticulitis
1
Myasthenia Gravis
1
Pruritus
1
Cough
1
Overdose
1
Blood Pressure Increased
1
Drug Therapy Changed
1
Benign Prostatic Hyperplasia
1
Blood Disorder
1
Analgesic Therapy
1
Fluid Retention
1
Drug Administration Error
1
Glucose Urine Present
1
Abdominal Pain Upper
1

Drug Labels

LabelLabelerEffective
JanuviaPhysicians Total Care, Inc.21-MAY-10
JanuviaLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-MAR-12
JanuviaCardinal Health05-MAR-13
JanuviaMerck Sharp & Dohme Corp.25-MAR-13

Januvia Case Reports

What Januvia safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Januvia. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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