This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Actos (Pioglitazone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (1721)
Death (223)
Life Threatening Events (114)
Disability (40)
Reports by Reaction Type
Bladder Cancer (1096),
Bladder Transitional Cell Carcinoma (104),
Haematuria (70),
Weight Increased (36),
Blood Glucose Increased (34),
Myocardial Infarction (33),
Bladder Neoplasm (27),
Cardiac Failure Congestive (26),
Dyspnoea (26),
Prostate Cancer (26),
Oedema Peripheral (24),
Transitional Cell Carcinoma (21)
Below are a few examples of reports where side effects / adverse reactions may be related to Actos (Pioglitazone). For a complete list or a specific selection of reports, please use the links above.
Possible Actos side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) on 2012-08-24
Patient: 53 year old male, weighing 103.4 kg (227.5 pounds)
Reactions: Bladder Cancer Recurrent
Drug(s) suspected as cause:
Actos
Possible Actos side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Nausea, Muscular Weakness, Headache, Abdominal Pain Upper, Tremor, Blood Glucose Abnormal, Blood Glucose Decreased, Malaise, Heart Rate Increased, Dizziness, Adverse Event, Bladder Disorder, Coordination Abnormal, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actos
Dosage: unk
Indication: Type 2 Diabetes Mellitus
End date: 2012-06-22
Amaryl
Dosage: 2 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2012-06-21
End date: 2012-06-22
Januvia
Dosage: unk
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2012-06-22
Other drugs received by patient: Temazepam; Lipitor; Tricor; Diovan; Lopressor
Possible Actos side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24
Patient:
Reactions: Tubulointerstitial Nephritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actos
Dosage: 7.5 mg, qd
Administration route: Oral
Indication: Blood Glucose Increased
Start date: 2011-01-01
End date: 2011-03-01
Candesartan Cilexetil
Dosage: 8 mg, qd
Administration route: Oral
Indication: Blood Pressure Increased
Start date: 2010-06-01
End date: 2011-04-01
Januvia
Dosage: 100 mg, qd
Administration route: Oral
Indication: Blood Glucose Increased
Start date: 2010-09-01
End date: 2011-03-01
Metformin HCL
Dosage: 500 mg, qd
Administration route: Oral
Indication: Blood Glucose Increased
Start date: 2010-11-01
End date: 2011-01-01
Micardis
Dosage: 80 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2010-06-01
Possible Actos side effects in
Reported by a consumer/non-health professional from Japan on 2012-08-23
Patient:
Reactions: Intestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actos
Administration route: Oral
Sitagliptin Phosphate
Dosage: 50 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2012-08-01
Possible Actos side effects in male
Reported by a consumer/non-health professional from Australia on 2012-08-23
Patient: male
Reactions: Death, Hyponatraemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Zocor; Lantus; Aldomet; Ramipril; Duatrol; Irbesartan and Hydrochlorothiazide; Nexium; Novorapid; Pristiq; Metformin HCL; Metoprolol Tartrate; Aspirin; Lercanidipine
Possible Actos side effects in 55 year old male
Reported by a physician from United States on 2012-08-20
Patient: 55 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actos
Dosage: 15 mg, unk
Indication: Type 2 Diabetes Mellitus
Metformin
Dosage: 2000 mg
Indication: Type 2 Diabetes Mellitus
Placebo
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-26
Ramipril
Dosage: unk
Saxagliptin
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-26
Other drugs received by patient: Acetylsalicylic Acid
Possible Actos side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female
Reactions: Bladder Mass, Injection Site Haematoma, Blood Glucose Increased
Drug(s) suspected as cause:
Actos
Indication: Type 2 Diabetes Mellitus
Rebif
Indication: Product Used FOR Unknown Indication
Start date: 2007-04-30
Possible Actos side effects in 48 year old male
Reported by a physician from United States on 2012-08-15
Patient: 48 year old male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Actos
Metformin HCL
Onglyza
Start date: 2012-04-01
End date: 2012-06-01
Possible Actos side effects in 55 year old male
Reported by a physician from United States on 2012-08-13
Patient: 55 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actos
Dosage: 15 mg, unk
Indication: Type 2 Diabetes Mellitus
Metformin HCL
Dosage: 2000 mg, unk
Indication: Type 2 Diabetes Mellitus
Placebo
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-26
Ramipril
Dosage: unk
Saxagliptin
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-26
Other drugs received by patient: Acetylsalicylic Acid
Possible Actos side effects in 78 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 78 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Benign Prostatic Hyperplasia, Bladder Transitional Cell Carcinoma
Drug(s) suspected as cause:
Actos
Possible Actos side effects in 52 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 52 year old male, weighing 82.6 kg (181.6 pounds)
Reactions: Bladder Transitional Cell Carcinoma
Drug(s) suspected as cause:
Actoplus MET
Indication: Type 2 Diabetes Mellitus
Start date: 2008-05-01
End date: 2010-01-01
Actos
Dosage: 15 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-01
End date: 2011-08-01
Actos
Dosage: 15 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2007-05-01
End date: 2007-12-01
Other drugs received by patient: Metformin HCL; Janumet; Metformin Hydrochloride
Possible Actos side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 55 year old male, weighing 93.9 kg (206.6 pounds)
Reactions: Metastases To Nervous System, Hepatic Cancer Metastatic, Pancreatitis, Convulsion, Bladder Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Insulin; Novolog
Possible Actos side effects in 50 year old male
Reported by a physician from United States on 2012-08-10
Patient: 50 year old male
Reactions: Bladder Transitional Cell Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Dosage: 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2004-10-27
End date: 2004-11-27
Actos
Dosage: 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2004-04-02
End date: 2004-05-02
Actos
Dosage: 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2004-06-01
End date: 2004-07-01
Actos
Dosage: 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2004-12-24
Other drugs received by patient: Lantus; Glucotrol; Glucophage; Novolog; Protonix
Possible Actos side effects in 64 year old male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 64 year old male
Reactions: Bladder Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Dosage: 15 mg, 1 in 1 d ; 30 mg, 1 in 1 d ; 45 mg, 1 in 1 d
Indication: Type 2 Diabetes Mellitus
Start date: 2005-07-13
End date: 2005-12-01
Actos
Dosage: 15 mg, 1 in 1 d ; 30 mg, 1 in 1 d ; 45 mg, 1 in 1 d
Indication: Type 2 Diabetes Mellitus
Start date: 2001-01-01
End date: 2005-01-01
Actos
Dosage: 15 mg, 1 in 1 d ; 30 mg, 1 in 1 d ; 45 mg, 1 in 1 d
Indication: Type 2 Diabetes Mellitus
Start date: 2005-05-12
End date: 2005-06-10
Other drugs received by patient: Lantus; Levemir; Glucophage; Avandia
Possible Actos side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 59 year old male
Reactions: Renal Cancer, Lung Cancer Metastatic, Bladder Cancer
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Diabeta; Avandia; Januvia
Possible Actos side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 66 year old male
Reactions: Bladder Transitional Cell Carcinoma
Drug(s) suspected as cause:
Actos
Dosage: 15 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2004-01-12
End date: 2005-12-26
Actos
Dosage: 15 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2005-12-27
End date: 2012-03-01
Other drugs received by patient: Cetirizine Hydrochloride; Triamcinolone Acetonide; Captopril
Possible Actos side effects in 65 year old male
Reported by a physician from United States on 2012-08-10
Patient: 65 year old male, weighing 113.4 kg (249.5 pounds)
Reactions: Prostate Cancer, Transitional Cell Carcinoma, Bladder Cancer
Drug(s) suspected as cause:
Actos
Dosage: 30 mg, 45 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2000-03-01
End date: 2002-04-23
Actos
Dosage: 30 mg, 45 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2002-04-23
End date: 2002-05-08
Other drugs received by patient: Aspirin; Prilosec; Novolog; Lisinopril; Glyburide; Metfformin Hydrochloride; Coreg; Glucophage; Lantus; Metfformin Hydrochloride
Possible Actos side effects in 51 year old female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 51 year old female, weighing 99.8 kg (219.5 pounds)
Reactions: Adrenal Neoplasm, Bladder Cancer
Drug(s) suspected as cause:
Actos
Indication: Type 2 Diabetes Mellitus
Start date: 2010-10-27
End date: 2011-01-20
Actos
Indication: Type 2 Diabetes Mellitus
Start date: 2008-05-01
End date: 2010-02-21
Actos
Indication: Type 2 Diabetes Mellitus
Start date: 2006-01-03
End date: 2006-03-13
Actos
Indication: Type 2 Diabetes Mellitus
Start date: 2010-04-16
End date: 2010-10-26
Actos
Indication: Type 2 Diabetes Mellitus
Start date: 2006-03-14
End date: 2008-04-30
Other drugs received by patient: Glargine / Lantus (Insulin Glargine); Metfformin Hydrochloride; Byetta
Possible Actos side effects in 56 year old male
Reported by a physician from United States on 2012-08-10
Patient: 56 year old male, weighing 88.5 kg (194.6 pounds)
Reactions: Prostatomegaly, Bladder Transitional Cell Carcinoma
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Amaryl; Levemir; Metfformin Hydrochloride; Insulin
Possible Actos side effects in 69 year old male
Reported by a physician from United States on 2012-08-10
Patient: 69 year old male, weighing 97.5 kg (214.6 pounds)
Reactions: Bladder Cancer
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Starlix; Diabeta; Januvia; Macrobid; Amaryl; Levemir; Avandia; Prandin (Deflazacodort); Lispro (Insulin)
Possible Actos side effects in
Reported by a physician from United States on 2012-08-10
Patient:
Reactions: Pruritus, Dyspnoea, Nausea, Erythema, Cardiac Failure Congestive
Drug(s) suspected as cause:
Actos
Indication: Product Used FOR Unknown Indication
Blockain
Indication: Product Used FOR Unknown Indication
Excedrin (United States)
Indication: Product Used FOR Unknown Indication
Levaquin
Indication: Product Used FOR Unknown Indication
Rocephin
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Lipitor; Spiriva; Niacin; Aspirin; Narcotics; Fish OIL; Albuterol; Fluticasone Propionate; Dimexid; Calcium D3; Levothyroxine Sodium; Aldactone; Glipizide; Potassium Chloride; Fosamax; Zantac; Ativan
Possible Actos side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 60 year old male, weighing 125.6 kg (276.4 pounds)
Reactions: Prostate Cancer, Urinary Tract Infection, Bladder Cancer
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Glucotrol; Metfformin Hydrochloride; Glucophage
Possible Actos side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 68 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Myocardial Infarction
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Metformin HCL
Possible Actos side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 72 year old male
Reactions: Bladder Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Captopril; Metfformin Hydrochloride; Plendil; Symlin; Lanoxin; Furosemide; Glipizide
Possible Actos side effects in 65 year old male
Reported by a physician from United States on 2012-08-10
Patient: 65 year old male
Reactions: Bladder Transitional Cell Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2008-12-20
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2005-02-14
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2005-08-23
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2005-06-17
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2008-02-24
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2007-09-27
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2007-11-26
Actos
Dosage: 15 mg, 15 mg, 15 mg, 30 mg, 30 mg, 30 mg, 30 mg, 30 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2008-06-28
Other drugs received by patient: Insulin Aspart; Insulin
Possible Actos side effects in 72 year old female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 72 year old female
Reactions: Bladder Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Possible Actos side effects in 63 year old male
Reported by a physician from Australia on 2012-08-10
Patient: 63 year old male
Reactions: Hyponatraemia
Drug(s) suspected as cause:
Actos
Dosage: 15 mg, 1x/day
Aldomet
Dosage: 750 mg, 2x/day
Aspirin
Dosage: 100 mg, each morning
Duatrol SR
Dosage: two 6 hourly, as needed
Irbesartan and Hydrochlorothiazide
Dosage: 1 df, 1x/day
Lantus
Dosage: unk
Lercanidipine
Dosage: 20 mg, 1x/day at night
Metformin HCL
Dosage: 1000 mg, 2x/day
Metoprolol
Dosage: 1 df, 2x/day
Nexium
Dosage: 20 mg, 1x/day
Novorapid
Dosage: unk
Pristiq
Dosage: 50 mg, 1x/day
Indication: Depression
Ramipril
Dosage: 10 mg, 1x/day at night
Zocor
Dosage: 80 mg, 1x/day
Possible Actos side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: female
Reactions: Bladder Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
Possible Actos side effects in 57 year old female
Reported by a physician from United States on 2012-08-09
Patient: 57 year old female, weighing 58.1 kg (127.7 pounds)
Reactions: Hepatic Cancer Stage IV, Ureteric Cancer, Skin Cancer, Bladder Cancer, Lung Carcinoma Cell Type Unspecified Stage IV
Drug(s) suspected as cause:
Actos
Other drugs received by patient: Diabeta; Glucotrol; Metformin HCL; Januvia
Possible Actos side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: male
Reactions: Bladder Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Actos
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