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Actos (Pioglitazone) - Side Effect Reports to FDA

 
 



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

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 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 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 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 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 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 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 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 58 year old male

Reported by a physician from United States on 2012-08-09

Patient: 58 year old male

Reactions: Prostate Cancer Stage II, Bladder Transitional Cell Carcinoma

Drug(s) suspected as cause:
Actos

Other drugs received by patient: Glucotrol; Glipizide



Possible Actos side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: 76 year old female

Reactions: Cerebrovascular Accident, Myocardial Infarction, Bladder Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Actos
    Dosage: 30 mg, 45 mg
    Indication: Type 2 Diabetes Mellitus
    Start date: 2004-04-01
    End date: 2005-02-01

Actos
    Dosage: 30 mg, 45 mg
    Indication: Type 2 Diabetes Mellitus
    Start date: 2005-03-01
    End date: 2011-07-01

Other drugs received by patient: Starlix; Micronase



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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