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Janumet Adverse Events Reported to the FDA Over Time

How are Janumet adverse event reports trending over time?

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

Most Common Janumet Adverse Events Reported to the FDA

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

Lactic Acidosis
3071 (4.61%)
Renal Failure Acute
2494 (3.75%)
Diarrhoea
1535 (2.31%)
Blood Glucose Increased
1231 (1.85%)
Vomiting
1189 (1.79%)
Hypoglycaemia
1128 (1.69%)
Nausea
1022 (1.54%)
Hypotension
798 (1.2%)
Completed Suicide
752 (1.13%)
Haemodialysis
730 (1.1%)
Metabolic Acidosis
707 (1.06%)
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Renal Failure
660 (.99%)
Dehydration
637 (.96%)
Malaise
563 (.85%)
Drug Ineffective
548 (.82%)
Hyperkalaemia
540 (.81%)
Dyspnoea
512 (.77%)
Abdominal Pain
506 (.76%)
Drug Interaction
490 (.74%)
Overdose
487 (.73%)
Weight Decreased
463 (.7%)
Dizziness
431 (.65%)
Cardiac Arrest
426 (.64%)
Blood Creatinine Increased
409 (.61%)
Asthenia
402 (.6%)
Pancreatitis
387 (.58%)
Fatigue
376 (.56%)
Renal Impairment
371 (.56%)
Somnolence
343 (.52%)
Pancreatitis Acute
342 (.51%)
Diabetes Mellitus Inadequate Contro...
328 (.49%)
Confusional State
318 (.48%)
Abdominal Pain Upper
299 (.45%)
Weight Increased
299 (.45%)
Blood Glucose Decreased
292 (.44%)
Fall
275 (.41%)
Headache
273 (.41%)
Hypertension
273 (.41%)
Suicide Attempt
273 (.41%)
Oedema Peripheral
255 (.38%)
Intentional Overdose
252 (.38%)
Decreased Appetite
251 (.38%)
Hypothermia
243 (.37%)
Loss Of Consciousness
237 (.36%)
Agitation
220 (.33%)
Abdominal Discomfort
219 (.33%)
Drug Toxicity
213 (.32%)
Pneumonia
213 (.32%)
Pyrexia
213 (.32%)
Death
212 (.32%)
Drug Exposure During Pregnancy
212 (.32%)
Alanine Aminotransferase Increased
206 (.31%)
Chest Pain
206 (.31%)
Glycosylated Haemoglobin Increased
203 (.31%)
Shock
201 (.3%)
Myocardial Infarction
196 (.29%)
Coma
191 (.29%)
Rhabdomyolysis
186 (.28%)
Continuous Haemodiafiltration
185 (.28%)
Anaemia
182 (.27%)
Myalgia
182 (.27%)
White Blood Cell Count Increased
182 (.27%)
Hyperglycaemia
177 (.27%)
General Physical Health Deteriorati...
176 (.26%)
Sepsis
176 (.26%)
Bradycardia
175 (.26%)
Aspartate Aminotransferase Increase...
170 (.26%)
Diabetes Mellitus
170 (.26%)
Pain In Extremity
169 (.25%)
Blood Pressure Increased
167 (.25%)
Constipation
167 (.25%)
Blood Pressure Decreased
166 (.25%)
Muscle Spasms
164 (.25%)
Respiratory Failure
164 (.25%)
Condition Aggravated
162 (.24%)
Depressed Level Of Consciousness
160 (.24%)
Pruritus
160 (.24%)
Tachypnoea
159 (.24%)
Multi-organ Failure
158 (.24%)
Rash
158 (.24%)
Poisoning
155 (.23%)
Acidosis
154 (.23%)
Dialysis
152 (.23%)
Heart Rate Increased
150 (.23%)
Anuria
148 (.22%)
Blood Potassium Increased
148 (.22%)
Haemoglobin Decreased
148 (.22%)
Urinary Tract Infection
145 (.22%)
Back Pain
144 (.22%)
Cerebrovascular Accident
144 (.22%)
Atrial Fibrillation
142 (.21%)
Hyperhidrosis
142 (.21%)
Pain
142 (.21%)
Gastrointestinal Disorder
140 (.21%)
Lethargy
138 (.21%)
Blood Lactic Acid Increased
137 (.21%)
Syncope
134 (.2%)
Intentional Drug Misuse
132 (.2%)
Blood Creatine Phosphokinase Increa...
130 (.2%)
Jaundice
128 (.19%)
Multiple Drug Overdose
128 (.19%)

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This graph shows the top adverse events submitted to the FDA for Janumet, 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 Janumet 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 Janumet

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

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This graph shows the top categories of adverse events submitted to the FDA for Janumet, 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 Janumet 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 Janumet According to Those Reporting Adverse Events

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

Diabetes Mellitus
15461
Type 2 Diabetes Mellitus
8554
Product Used For Unknown Indication
4343
Drug Use For Unknown Indication
3228
Diabetes Mellitus Non-insulin-depen...
1160
Polycystic Ovaries
471
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Glucose Tolerance Impaired
264
Blood Glucose Increased
181
Blood Glucose Abnormal
148
Hyperglycaemia
147
Insulin Resistance
117
Gestational Diabetes
97
Blood Glucose
92
Type 1 Diabetes Mellitus
88
Ill-defined Disorder
88
Suicide Attempt
77
Insulin-requiring Type 2 Diabetes M...
60
Diabetes Mellitus Management
50
Hypertension
43
Weight Decreased
39
Diabetes Mellitus Inadequate Contro...
38
Insulin-requiring Type Ii Diabetes ...
35
Weight Control
30
Metabolic Syndrome
30
Obesity
30
Intentional Overdose
27
Completed Suicide
21
Diabetes Mellitus Insulin-dependent
21
Infertility
20
Diabetes Prophylaxis
17
Drug Exposure During Pregnancy
17
Hyperinsulinaemia
17
Blood Testosterone Abnormal
17
Prophylaxis
13
Cardiac Disorder
13
Blood Cholesterol Increased
11
Glycosylated Haemoglobin Increased
10
Blood Cholesterol
9
Unevaluable Event
9
Incorrect Dose Administered
9
Blood Triglycerides Increased
9
Hyperlipidaemia
8
Foetal Exposure During Pregnancy
8
Weight Increased
8
Abortion Spontaneous
7
Hypoglycaemia
7
Metabolic Disorder
7
Hepatic Steatosis
7
Cushings Syndrome
6
Overdose
6
Insulin Resistant Diabetes
6

Drug Labels

LabelLabelerEffective
JanumetPhysicians Total Care, Inc.21-MAY-10
JanumetLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-MAR-12
Janumet XrMerck Sharp & Dohme Corp.11-FEB-13
JanumetMerck Sharp & Dohme Corp.25-MAR-13

Janumet Case Reports

What Janumet 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 Janumet. 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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