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ACTOPLUS MET

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Actoplus Met Adverse Events Reported to the FDA Over Time

How are Actoplus Met adverse event reports trending over time?

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

Most Common Actoplus Met Adverse Events Reported to the FDA

What are the most common Actoplus Met adverse events reported to the FDA?

Lactic Acidosis
3018 (4.67%)
Renal Failure Acute
2399 (3.71%)
Diarrhoea
1468 (2.27%)
Blood Glucose Increased
1203 (1.86%)
Vomiting
1169 (1.81%)
Hypoglycaemia
1074 (1.66%)
Nausea
975 (1.51%)
Hypotension
788 (1.22%)
Completed Suicide
766 (1.19%)
Haemodialysis
729 (1.13%)
Metabolic Acidosis
681 (1.05%)
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Dehydration
607 (.94%)
Renal Failure
599 (.93%)
Malaise
546 (.84%)
Dyspnoea
535 (.83%)
Hyperkalaemia
517 (.8%)
Drug Ineffective
509 (.79%)
Abdominal Pain
496 (.77%)
Drug Interaction
485 (.75%)
Overdose
439 (.68%)
Cardiac Arrest
423 (.65%)
Weight Decreased
407 (.63%)
Asthenia
403 (.62%)
Dizziness
400 (.62%)
Blood Creatinine Increased
378 (.58%)
Renal Impairment
376 (.58%)
Fatigue
372 (.58%)
Somnolence
334 (.52%)
Diabetes Mellitus Inadequate Contro...
323 (.5%)
Confusional State
319 (.49%)
Weight Increased
318 (.49%)
Fall
312 (.48%)
Blood Glucose Decreased
300 (.46%)
Pancreatitis Acute
293 (.45%)
Oedema Peripheral
286 (.44%)
Headache
266 (.41%)
Suicide Attempt
266 (.41%)
Hypertension
263 (.41%)
Loss Of Consciousness
261 (.4%)
Abdominal Pain Upper
245 (.38%)
Intentional Overdose
245 (.38%)
Hypothermia
235 (.36%)
Decreased Appetite
230 (.36%)
Myocardial Infarction
224 (.35%)
Agitation
222 (.34%)
Drug Toxicity
216 (.33%)
Chest Pain
215 (.33%)
Pneumonia
209 (.32%)
Drug Exposure During Pregnancy
206 (.32%)
Abdominal Discomfort
204 (.32%)
Shock
204 (.32%)
Glycosylated Haemoglobin Increased
199 (.31%)
Death
198 (.31%)
Pancreatitis
193 (.3%)
Pyrexia
187 (.29%)
Myalgia
186 (.29%)
Coma
185 (.29%)
Anaemia
184 (.28%)
Continuous Haemodiafiltration
183 (.28%)
Condition Aggravated
176 (.27%)
Sepsis
175 (.27%)
White Blood Cell Count Increased
174 (.27%)
Alanine Aminotransferase Increased
173 (.27%)
Bradycardia
173 (.27%)
Cardiac Failure Congestive
170 (.26%)
Diabetes Mellitus
170 (.26%)
Hyperglycaemia
169 (.26%)
General Physical Health Deteriorati...
168 (.26%)
Depressed Level Of Consciousness
166 (.26%)
Rhabdomyolysis
164 (.25%)
Blood Pressure Decreased
162 (.25%)
Respiratory Failure
162 (.25%)
Atrial Fibrillation
160 (.25%)
Tachypnoea
160 (.25%)
Poisoning
159 (.25%)
Blood Pressure Increased
157 (.24%)
Constipation
154 (.24%)
Dialysis
153 (.24%)
Multi-organ Failure
152 (.24%)
Muscle Spasms
151 (.23%)
Pain In Extremity
150 (.23%)
Acidosis
148 (.23%)
Blood Potassium Increased
148 (.23%)
Aspartate Aminotransferase Increase...
145 (.22%)
Haemoglobin Decreased
143 (.22%)
Heart Rate Increased
142 (.22%)
Syncope
142 (.22%)
Lethargy
137 (.21%)
Anuria
136 (.21%)
Intentional Drug Misuse
133 (.21%)
Blood Creatine Phosphokinase Increa...
132 (.2%)
Gastrointestinal Disorder
132 (.2%)
Pruritus
132 (.2%)
Cardiac Failure
131 (.2%)
Cerebrovascular Accident
131 (.2%)
Rash
131 (.2%)
Hyperhidrosis
130 (.2%)
Back Pain
128 (.2%)
Blood Lactic Acid Increased
127 (.2%)
Jaundice
125 (.19%)
Multiple Drug Overdose
125 (.19%)

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

What are the most common Actoplus Met adverse events reported to the FDA?

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

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

Diabetes Mellitus
15011
Type 2 Diabetes Mellitus
7983
Product Used For Unknown Indication
4285
Drug Use For Unknown Indication
3322
Diabetes Mellitus Non-insulin-depen...
1318
Polycystic Ovaries
471
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Glucose Tolerance Impaired
329
Blood Glucose Increased
177
Blood Glucose Abnormal
148
Hyperglycaemia
147
Insulin Resistance
118
Gestational Diabetes
97
Ill-defined Disorder
94
Type 1 Diabetes Mellitus
82
Suicide Attempt
78
Blood Glucose
65
Cardiovascular Event Prophylaxis
54
Diabetes Mellitus Management
52
Insulin-requiring Type 2 Diabetes M...
50
Hypertension
42
Insulin-requiring Type Ii Diabetes ...
40
Weight Decreased
37
Diabetes Mellitus Inadequate Contro...
35
Cerebrovascular Accident Prophylaxi...
35
Metabolic Syndrome
33
Obesity
30
Weight Control
30
Intentional Overdose
27
Prophylaxis
25
Completed Suicide
25
Diabetes Mellitus Insulin-dependent
24
Infertility
20
Diabetes Prophylaxis
20
Blood Testosterone Abnormal
17
Hyperinsulinaemia
17
Drug Exposure During Pregnancy
17
Hyperlipidaemia
13
Cardiac Disorder
13
Blood Cholesterol Increased
11
Ischaemic Heart Disease Prophylaxis
11
Blood Triglycerides Increased
10
Hepatic Steatosis
10
Blood Cholesterol
10
Multiple Myeloma
9
Incorrect Dose Administered
9
Unevaluable Event
9
Foetal Exposure During Pregnancy
8
Weight Increased
8
Metabolic Disorder
8
Hypoglycaemia
8
Blood Glucose Fluctuation
8

Drug Labels

LabelLabelerEffective
Actoplus MetPhysicians Total Care, Inc.24-FEB-10
Actoplus MetCardinal Health16-AUG-12
Actoplus MetTakeda Pharmaceuticals America, Inc.30-SEP-12
Actoplus MetxrTakeda Pharmaceuticals America, Inc.31-OCT-12

Actoplus Met Case Reports

What Actoplus Met 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 Actoplus Met. 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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