PIOGLITAZONE

Pioglitazone Adverse Events Reported to the FDA Over Time

How are Pioglitazone adverse event reports trending over time?

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

Most Common Pioglitazone Adverse Events Reported to the FDA

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

Bladder Cancer	1763 (6.67%)
Weight Increased	564 (2.13%)
Oedema Peripheral	494 (1.87%)
Blood Glucose Increased	418 (1.58%)
Dyspnoea	414 (1.57%)
Cardiac Failure Congestive	307 (1.16%)
Myocardial Infarction	284 (1.07%)
Fall	273 (1.03%)
Cardiac Failure	247 (.93%)
Bladder Transitional Cell Carcinoma	243 (.92%)
Hypoglycaemia	226 (.85%)
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Haematuria	220 (.83%)
Nausea	208 (.79%)
Chest Pain	191 (.72%)
Dizziness	190 (.72%)
Condition Aggravated	182 (.69%)
Fatigue	181 (.68%)
Oedema	172 (.65%)
Asthenia	170 (.64%)
Pleural Effusion	167 (.63%)
Glycosylated Haemoglobin Increased	158 (.6%)
Malaise	158 (.6%)
Diabetes Mellitus Inadequate Contro...	154 (.58%)
Headache	143 (.54%)
Vomiting	142 (.54%)
Fluid Retention	141 (.53%)
Anaemia	140 (.53%)
Weight Decreased	135 (.51%)
Pneumonia	131 (.5%)
Blood Glucose Decreased	124 (.47%)
Atrial Fibrillation	120 (.45%)
Renal Failure Acute	118 (.45%)
Macular Oedema	117 (.44%)
Renal Failure	114 (.43%)
Diarrhoea	113 (.43%)
Pulmonary Oedema	113 (.43%)
Drug Ineffective	112 (.42%)
Hypertension	112 (.42%)
Loss Of Consciousness	109 (.41%)
Myalgia	109 (.41%)
Alanine Aminotransferase Increased	100 (.38%)
Treatment Noncompliance	97 (.37%)
Abdominal Pain	95 (.36%)
Drug Interaction	94 (.36%)
Arthralgia	91 (.34%)
Acute Myocardial Infarction	90 (.34%)
Joint Swelling	89 (.34%)
Cerebrovascular Accident	86 (.33%)
Aspartate Aminotransferase Increase...	85 (.32%)
Cardiomegaly	85 (.32%)
Pyrexia	84 (.32%)
Blood Pressure Increased	83 (.31%)
Pain In Extremity	81 (.31%)
Vision Blurred	80 (.3%)
Cough	79 (.3%)
Abdominal Distension	78 (.3%)
Pain	77 (.29%)
Incorrect Dose Administered	76 (.29%)
Feeling Abnormal	75 (.28%)
Decreased Appetite	73 (.28%)
Bladder Neoplasm	72 (.27%)
Liver Disorder	72 (.27%)
Coronary Artery Occlusion	71 (.27%)
Medication Error	71 (.27%)
Palpitations	70 (.26%)
Prostate Cancer	69 (.26%)
Back Pain	67 (.25%)
Depression	67 (.25%)
Cardiac Disorder	66 (.25%)
Generalised Oedema	66 (.25%)
Completed Suicide	65 (.25%)
Dehydration	65 (.25%)
Swelling	64 (.24%)
Urinary Tract Infection	64 (.24%)
Tremor	63 (.24%)
Hyperhidrosis	61 (.23%)
Renal Impairment	61 (.23%)
Abdominal Pain Upper	60 (.23%)
Depressed Level Of Consciousness	60 (.23%)
Gait Disturbance	60 (.23%)
Coronary Artery Disease	59 (.22%)
Somnolence	59 (.22%)
Blood Creatine Phosphokinase Increa...	58 (.22%)
Dyspnoea Exertional	58 (.22%)
Nasopharyngitis	58 (.22%)
Angina Pectoris	56 (.21%)
Haemoglobin Decreased	56 (.21%)
Chest Discomfort	55 (.21%)
Heart Rate Increased	55 (.21%)
Pericardial Effusion	55 (.21%)
Rash	55 (.21%)
Transitional Cell Carcinoma	55 (.21%)
Interstitial Lung Disease	54 (.2%)
Rhabdomyolysis	54 (.2%)
Blood Lactate Dehydrogenase Increas...	53 (.2%)
Cerebral Infarction	52 (.2%)
Visual Acuity Reduced	52 (.2%)
Anorexia	51 (.19%)
Drug Dispensing Error	51 (.19%)
Gamma-glutamyltransferase Increased	50 (.19%)
Platelet Count Decreased	50 (.19%)

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

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

Renal And Urinary Tract Neoplasms M...	2356 (8.91%)
Respiratory	916 (3.47%)
Metabolic, Nutritional And Blood Ga...	829 (3.14%)
Neurological	818 (3.09%)
Physical Examination Topics	746 (2.82%)
Gastrointestinal Signs	734 (2.78%)
Coronary Artery	681 (2.58%)
Heart Failures	636 (2.41%)
Infections - Pathogen Unspecified	603 (2.28%)
Cardiac Arrhythmias	511 (1.93%)
Glucose Metabolism Disorders	511 (1.93%)
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Hepatic And Hepatobiliary	508 (1.92%)
Injuries	459 (1.74%)
Renal Disorders	444 (1.68%)
Urinary Tract Signs	437 (1.65%)
Bone And Joint Injuries	423 (1.6%)
Cardiac And Vascular Investigations	405 (1.53%)
Epidermal And Dermal Conditions	394 (1.49%)
Medication Errors	354 (1.34%)
Hematology Investigations	351 (1.33%)
Electrolyte And Fluid Balance Condi...	349 (1.32%)
Lower Respiratory Tract Disorders	347 (1.31%)
Hepatobiliary	328 (1.24%)
Muscle	312 (1.18%)
Therapeutic And Nontherapeutic Effe...	303 (1.15%)
Central Nervous System Vascular	272 (1.03%)
Musculoskeletal And Connective Tiss...	252 (.95%)
Joint	243 (.92%)
Myocardial	239 (.9%)
Renal And Urinary Tract Investigati...	231 (.87%)
Vision	225 (.85%)
Anemias Nonhemolytic And Marrow Dep...	213 (.81%)
Gastrointestinal Motility And Defec...	198 (.75%)
Lifestyle Issues	196 (.74%)
Appetite And General Nutritional	185 (.7%)
Enzyme	184 (.7%)
Pleural	183 (.69%)
Ocular Infections, Irritations And ...	177 (.67%)
Cardiac Disorder Signs	169 (.64%)
Headaches	162 (.61%)
Gastrointestinal Neoplasms Malignan...	150 (.57%)
Movement Disorders	131 (.5%)
Vascular Hypertensive	128 (.48%)
Metastases	120 (.45%)
Retina, Choroid And Vitreous Hemorr...	118 (.45%)
Lipid Analyses	117 (.44%)
Suicidal And Self-injurious Behavio...	110 (.42%)
Bacterial Infectious	107 (.4%)
Fatal Outcomes	105 (.4%)
Skin Appendage Conditions	101 (.38%)
Arteriosclerosis, Stenosis, Vascula...	100 (.38%)
Anxiety Disorders	99 (.37%)
Cardiac Valve	98 (.37%)
Vascular	96 (.36%)
Water, Electrolyte And Mineral	96 (.36%)
Exocrine Pancreas Conditions	94 (.36%)
Dental And Gingival Conditions	93 (.35%)
Body Temperature Conditions	92 (.35%)
Decreased And Nonspecific Blood Pre...	89 (.34%)
Bronchial Disorders	82 (.31%)
Depressed Mood Disorders	79 (.3%)
Acid-base	78 (.3%)
Allergic Conditions	76 (.29%)
Gastrointestinal Hemorrhages	76 (.29%)
Pericardial	74 (.28%)
Reproductive Neoplasms Male Maligna...	74 (.28%)
Chemical Injury And Poisoning	71 (.27%)
Bone Disorders	69 (.26%)
Gastrointestinal Inflammatory Condi...	69 (.26%)
Pulmonary Vascular	69 (.26%)
Gallbladder	68 (.26%)
Mental Impairment	66 (.25%)
Deliria	65 (.25%)
Hematological And Lymphoid Tissue T...	65 (.25%)
Sleep Disorders	65 (.25%)
Viral Infectious	64 (.24%)
Bladder And Bladder Neck Disorders	63 (.24%)
Miscellaneous And Site Unspecified ...	60 (.23%)
Nephropathies	59 (.22%)
Eye	54 (.2%)
Peritoneal And Retroperitoneal Cond...	53 (.2%)
Protein And Chemistry Analyses	53 (.2%)
Procedural And Device Related Injur...	51 (.19%)
Angiedema And Urticaria	50 (.19%)
Psychiatric	50 (.19%)
Upper Respiratory Tract Disorders	50 (.19%)
Platelet	47 (.18%)
Respiratory And Mediastinal Neoplas...	47 (.18%)
Musculoskeletal And Connective Tiss...	44 (.17%)
Ocular Structural Change, Deposit A...	44 (.17%)
Urolithiases	44 (.17%)
Hepatobiliary Neoplasms Malignant A...	43 (.16%)
Therapeutic Procedures And Supporti...	43 (.16%)
Tissue	43 (.16%)
Gastrointestinal Ulceration And Per...	42 (.16%)
White Blood Cell	41 (.16%)
Gastrointestinal Conditions	40 (.15%)
Seizures	40 (.15%)
Vascular Therapeutic Procedures	40 (.15%)
Anterior Eye Structural Change, Dep...	38 (.14%)
Vascular Hemorrhagic	38 (.14%)

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This graph shows the top categories of adverse events submitted to the FDA for Pioglitazone, 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 Pioglitazone 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.