ACTOS

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Actos Adverse Events Reported to the FDA Over Time

How are Actos adverse event reports trending over time?

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

Most Common Actos Adverse Events Reported to the FDA

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

Bladder Cancer	1724 (6.72%)
Weight Increased	550 (2.14%)
Oedema Peripheral	482 (1.88%)
Blood Glucose Increased	404 (1.57%)
Dyspnoea	399 (1.56%)
Cardiac Failure Congestive	298 (1.16%)
Myocardial Infarction	269 (1.05%)
Fall	263 (1.03%)
Cardiac Failure	245 (.95%)
Bladder Transitional Cell Carcinoma	237 (.92%)
Hypoglycaemia	220 (.86%)
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Haematuria	219 (.85%)
Nausea	200 (.78%)
Chest Pain	184 (.72%)
Dizziness	182 (.71%)
Condition Aggravated	179 (.7%)
Fatigue	172 (.67%)
Oedema	168 (.65%)
Pleural Effusion	166 (.65%)
Asthenia	162 (.63%)
Glycosylated Haemoglobin Increased	156 (.61%)
Malaise	153 (.6%)
Diabetes Mellitus Inadequate Contro...	151 (.59%)
Fluid Retention	140 (.55%)
Headache	139 (.54%)
Anaemia	138 (.54%)
Vomiting	138 (.54%)
Pneumonia	128 (.5%)
Weight Decreased	124 (.48%)
Atrial Fibrillation	119 (.46%)
Macular Oedema	114 (.44%)
Renal Failure	112 (.44%)
Blood Glucose Decreased	111 (.43%)
Hypertension	111 (.43%)
Renal Failure Acute	110 (.43%)
Drug Ineffective	109 (.42%)
Diarrhoea	108 (.42%)
Pulmonary Oedema	107 (.42%)
Loss Of Consciousness	102 (.4%)
Alanine Aminotransferase Increased	99 (.39%)
Myalgia	98 (.38%)
Abdominal Pain	92 (.36%)
Drug Interaction	92 (.36%)
Treatment Noncompliance	92 (.36%)
Acute Myocardial Infarction	88 (.34%)
Arthralgia	88 (.34%)
Cerebrovascular Accident	86 (.34%)
Joint Swelling	86 (.34%)
Aspartate Aminotransferase Increase...	84 (.33%)
Pyrexia	84 (.33%)
Blood Pressure Increased	83 (.32%)
Cardiomegaly	83 (.32%)
Cough	78 (.3%)
Pain In Extremity	78 (.3%)
Vision Blurred	78 (.3%)
Abdominal Distension	76 (.3%)
Pain	75 (.29%)
Feeling Abnormal	71 (.28%)
Liver Disorder	71 (.28%)
Bladder Neoplasm	70 (.27%)
Medication Error	70 (.27%)
Palpitations	70 (.27%)
Decreased Appetite	69 (.27%)
Prostate Cancer	69 (.27%)
Cardiac Disorder	66 (.26%)
Coronary Artery Occlusion	66 (.26%)
Completed Suicide	65 (.25%)
Generalised Oedema	65 (.25%)
Incorrect Dose Administered	65 (.25%)
Back Pain	64 (.25%)
Depression	64 (.25%)
Swelling	63 (.25%)
Dehydration	62 (.24%)
Tremor	61 (.24%)
Urinary Tract Infection	61 (.24%)
Renal Impairment	60 (.23%)
Gait Disturbance	59 (.23%)
Hyperhidrosis	59 (.23%)
Blood Creatine Phosphokinase Increa...	58 (.23%)
Dyspnoea Exertional	58 (.23%)
Coronary Artery Disease	57 (.22%)
Depressed Level Of Consciousness	57 (.22%)
Nasopharyngitis	57 (.22%)
Abdominal Pain Upper	56 (.22%)
Haemoglobin Decreased	56 (.22%)
Angina Pectoris	55 (.21%)
Heart Rate Increased	55 (.21%)
Chest Discomfort	54 (.21%)
Interstitial Lung Disease	54 (.21%)
Pericardial Effusion	54 (.21%)
Somnolence	54 (.21%)
Blood Lactate Dehydrogenase Increas...	53 (.21%)
Transitional Cell Carcinoma	53 (.21%)
Cerebral Infarction	52 (.2%)
Rash	52 (.2%)
Rhabdomyolysis	52 (.2%)
Visual Acuity Reduced	51 (.2%)
Anorexia	50 (.19%)
Gamma-glutamyltransferase Increased	50 (.19%)
Platelet Count Decreased	50 (.19%)
Acute Pulmonary Oedema	49 (.19%)

Share/Embed Graph Export Data

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

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

Renal And Urinary Tract Neoplasms M...	2302 (8.97%)
Respiratory	893 (3.48%)
Metabolic, Nutritional And Blood Ga...	796 (3.1%)
Neurological	775 (3.02%)
Physical Examination Topics	720 (2.81%)
Gastrointestinal Signs	704 (2.74%)
Coronary Artery	653 (2.55%)
Heart Failures	624 (2.43%)
Infections - Pathogen Unspecified	590 (2.3%)
Cardiac Arrhythmias	503 (1.96%)
Glucose Metabolism Disorders	502 (1.96%)
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Hepatic And Hepatobiliary	501 (1.95%)
Injuries	441 (1.72%)
Urinary Tract Signs	436 (1.7%)
Renal Disorders	428 (1.67%)
Bone And Joint Injuries	406 (1.58%)
Cardiac And Vascular Investigations	403 (1.57%)
Epidermal And Dermal Conditions	371 (1.45%)
Hematology Investigations	349 (1.36%)
Electrolyte And Fluid Balance Condi...	340 (1.33%)
Lower Respiratory Tract Disorders	339 (1.32%)
Hepatobiliary	326 (1.27%)
Medication Errors	323 (1.26%)
Therapeutic And Nontherapeutic Effe...	297 (1.16%)
Muscle	282 (1.1%)
Central Nervous System Vascular	270 (1.05%)
Musculoskeletal And Connective Tiss...	238 (.93%)
Myocardial	237 (.92%)
Joint	236 (.92%)
Renal And Urinary Tract Investigati...	231 (.9%)
Vision	220 (.86%)
Anemias Nonhemolytic And Marrow Dep...	209 (.81%)
Gastrointestinal Motility And Defec...	192 (.75%)
Lifestyle Issues	189 (.74%)
Enzyme	184 (.72%)
Pleural	182 (.71%)
Appetite And General Nutritional	178 (.69%)
Ocular Infections, Irritations And ...	174 (.68%)
Cardiac Disorder Signs	169 (.66%)
Headaches	158 (.62%)
Gastrointestinal Neoplasms Malignan...	149 (.58%)
Vascular Hypertensive	126 (.49%)
Movement Disorders	123 (.48%)
Retina, Choroid And Vitreous Hemorr...	118 (.46%)
Lipid Analyses	117 (.46%)
Metastases	117 (.46%)
Suicidal And Self-injurious Behavio...	109 (.42%)
Bacterial Infectious	106 (.41%)
Fatal Outcomes	101 (.39%)
Cardiac Valve	97 (.38%)
Skin Appendage Conditions	97 (.38%)
Arteriosclerosis, Stenosis, Vascula...	96 (.37%)
Water, Electrolyte And Mineral	93 (.36%)
Dental And Gingival Conditions	92 (.36%)
Exocrine Pancreas Conditions	92 (.36%)
Anxiety Disorders	91 (.35%)
Body Temperature Conditions	90 (.35%)
Vascular	90 (.35%)
Decreased And Nonspecific Blood Pre...	86 (.34%)
Bronchial Disorders	77 (.3%)
Gastrointestinal Hemorrhages	76 (.3%)
Depressed Mood Disorders	75 (.29%)
Reproductive Neoplasms Male Maligna...	73 (.28%)
Acid-base	72 (.28%)
Pericardial	72 (.28%)
Allergic Conditions	69 (.27%)
Chemical Injury And Poisoning	69 (.27%)
Gastrointestinal Inflammatory Condi...	69 (.27%)
Gallbladder	67 (.26%)
Bone Disorders	65 (.25%)
Mental Impairment	65 (.25%)
Deliria	63 (.25%)
Pulmonary Vascular	63 (.25%)
Sleep Disorders	63 (.25%)
Bladder And Bladder Neck Disorders	62 (.24%)
Viral Infectious	62 (.24%)
Hematological And Lymphoid Tissue T...	61 (.24%)
Miscellaneous And Site Unspecified ...	59 (.23%)
Nephropathies	59 (.23%)
Peritoneal And Retroperitoneal Cond...	53 (.21%)
Protein And Chemistry Analyses	53 (.21%)
Eye	52 (.2%)
Psychiatric	49 (.19%)
Procedural And Device Related Injur...	48 (.19%)
Platelet	47 (.18%)
Respiratory And Mediastinal Neoplas...	47 (.18%)
Upper Respiratory Tract Disorders	46 (.18%)
Ocular Structural Change, Deposit A...	44 (.17%)
Gastrointestinal Ulceration And Per...	42 (.16%)
Musculoskeletal And Connective Tiss...	42 (.16%)
Urolithiases	41 (.16%)
White Blood Cell	41 (.16%)
Hepatobiliary Neoplasms Malignant A...	40 (.16%)
Therapeutic Procedures And Supporti...	40 (.16%)
Tissue	40 (.16%)
Vascular Therapeutic Procedures	40 (.16%)
Seizures	39 (.15%)
Anterior Eye Structural Change, Dep...	38 (.15%)
Gastrointestinal Conditions	38 (.15%)
Angiedema And Urticaria	37 (.14%)
Vascular Hemorrhagic	36 (.14%)

Share/Embed Graph Export Data

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

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

Diabetes Mellitus	4376
Type 2 Diabetes Mellitus	3372
Diabetes Mellitus Non-insulin-depen...	1270
Drug Use For Unknown Indication	845
Product Used For Unknown Indication	754
Glucose Tolerance Impaired	100
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Cardiovascular Event Prophylaxis	53
Blood Glucose Increased	51
Blood Glucose Abnormal	49
Insulin-requiring Type Ii Diabetes ...	47
Insulin Resistance	36
Hyperglycaemia	35
Cerebrovascular Accident Prophylaxi...	34
Diabetes Mellitus Inadequate Contro...	26
Ill-defined Disorder	25
Diabetes Mellitus Insulin-dependent	22
Insulin-requiring Type 2 Diabetes M...	22
Prophylaxis	20
Blood Glucose	18
Diabetes Mellitus Management	16
Type 1 Diabetes Mellitus	15
Polycystic Ovaries	13
Hypertension	12
Ischaemic Heart Disease Prophylaxis	11
Blood Glucose Fluctuation	10
Insulin Resistant Diabetes	10
Prostate Cancer	9
Multiple Myeloma	9
Diabetes Prophylaxis	8
Metabolic Syndrome	8
Cerebrovascular Accident	7
Hyperlipidaemia	6
Myocardial Infarction	6
Sarcoma	6
Glycosylated Haemoglobin Increased	6
Hepatic Steatosis	6
Blood Cholesterol Increased	6
Blood Glucose Decreased	5
Hypoglycaemia	5
Rheumatoid Arthritis	5
Blood Triglycerides Increased	4
Investigation	4
Detoxification	4
Completed Suicide	4
Blood Cholesterol	4
Renal Impairment	3
Congenital Generalised Lipodystroph...	3
Pulmonary Oedema	3
High Density Lipoprotein Decreased	3
Obesity	3
Gestational Diabetes	3

Drug Labels

Label	Labeler	Effective
Actos	Takeda Pharmaceutical Co LTD	02-AUG-10
Actos	Rebel Distributors Corp.	01-SEP-10
Actos	Cardinal Health	09-JUN-11
Actos	Dispensing Solutions, Inc.	14-SEP-11
Actos	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	22-FEB-12
Actos	Takeda Pharmaceuticals America, Inc.	31-AUG-12
Actos	Physicians Total Care, Inc.	24-SEP-12
Actos	REMEDYREPACK INC.	02-APR-13
Actos	Cardinal Health	26-APR-13

Actos Case Reports

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

About Results

This report contains aggregated drug side effects and adverse events for Actos. 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.

Comments

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