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Actos Side Effects

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Common Actos Side Effects


The most commonly reported Actos side effects (click to view or check a box to report):

Bladder Cancer (551)
Weight Increased (313)
Oedema Peripheral (273)
Dyspnoea (247)
Blood Glucose Increased (212)
Cardiac Failure Congestive (170)
Fall (167)
Cardiac Failure (144)
Myocardial Infarction (134)
Condition Aggravated (105)
Asthenia (104)
Dizziness (101)
Pleural Effusion (99)
Fluid Retention (94)
Bladder Transitional Cell Carcinoma (93)
Chest Pain (91)
Fatigue (91)
Haematuria (87)
Diabetes Mellitus Inadequate Control (80)
Anaemia (80)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Actos Side Effects Reported to FDA



Actos Side Effect Report#9972376
Bladder Neoplasm
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Actos (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Bladder Neoplasm after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos treatment in female patients, resulting in Bladder Neoplasm side effect.
Actos Side Effect Report#9922812
Intentional Overdose, Altered State Of Consciousness, Metabolic Acidosis, Multi-organ Failure
This report suggests a potential Actos Tablets 15 Intentional Overdose side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: suicide attempt and used Actos Tablets 15 (dosage: 600 Mg, Qd) starting NS. After starting Actos Tablets 15 the patient began experiencing various side effects, including: Intentional Overdose, Altered State Of Consciousness, Metabolic Acidosis, Multi-organ FailureAdditional drugs used concurrently:
  • Metformin Hydrochloride (20000 Mg, Qd)
The patient was hospitalized. Although Actos Tablets 15 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intentional Overdose, may still occur.
Actos Side Effect Report#9922359
Bladder Cancer
This Bladder Cancer problem was reported by a consumer or non-health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Oct 05, 2005 this consumer started treatment with Actos (dosage: 1 1 Per Day By Mouth). The following drugs were being taken at the same time:
  • Metformin
  • Losartan
  • Simvastatin
  • Fish Oil
  • Multivitamin
When using Actos, the patient experienced the following unwanted symptoms/side effects: Bladder CancerThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actos Side Effect Report#9871842
Pancytopenia
This Pancytopenia side effect was reported by a physician from JP. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Actos Tablets 30 (drug dosage: 15 Mg, Qd), which was initiated on
Aug 07, 2013. Concurrently used drugs: NA..After starting to take Actos Tablets 30 the consumer reported adverse symptoms, such as: PancytopeniaThese side effects may potentially be related to Actos Tablets 30.
Actos Side Effect Report#9840103
Abdominal Discomfort
This is a report of a 66-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Actos (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos treatment in female patients, resulting in Abdominal Discomfort side effect.
Actos Side Effect Report#9828768
Ureteric Cancer, Metastases To Lymph Nodes
This report suggests a potential Actos Tablets 30 Ureteric Cancer side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actos Tablets 30 (dosage: 7.5 Mg, Qd) starting
Mar 03, 2005. After starting Actos Tablets 30 the patient began experiencing various side effects, including: Ureteric Cancer, Metastases To Lymph NodesAdditional drugs used concurrently:
  • Pariet (10 Mg, Qd)
  • Solanax (0.4 Mg, Qd)
  • Norvasc (5 Mg, Qd)
  • Co Dio Combination Ex (1 Df, Qd)
  • Pravastatin Sodium (10 Mg, Qd)
  • Glactiv (25 Mg, Qd)
  • Lantus (4 Ut, Qd)
Although Actos Tablets 30 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ureteric Cancer, may still occur.
Actos Side Effect Report#9818994
Bladder Cancer
This Bladder Cancer problem was reported by a health professional from SE. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On 2010 this consumer started treatment with Actos (dosage: 15 Mg, Qd). The following drugs were being taken at the same time: NA. When using Actos, the patient experienced the following unwanted symptoms/side effects: Bladder CancerThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actos Side Effect Report#9790347
Ureteric Cancer, Bladder Cancer
This Ureteric Cancer side effect was reported by a physician from JP. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Actos Tablets 15 (drug dosage: 15 Mg, 1 Days), which was initiated on 2002. Concurrently used drugs:
  • Glimicron (Unk)
  • Nu-lotan
  • Nu-lotan
  • Norvasc
  • Norvasc
  • Natrix
  • Natrix
  • Lipitor
.After starting to take Actos Tablets 15 the consumer reported adverse symptoms, such as: Ureteric Cancer, Bladder CancerThese side effects may potentially be related to Actos Tablets 15.
Actos Side Effect Report#9767703
Hyponatraemia, Oedema
This is a report of a 92-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Actos (dosage: NA, start time: NS), combined with:
  • Mesina
  • Equa
and developed a serious reaction and side effect(s): Hyponatraemia, Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos treatment in female patients, resulting in Hyponatraemia side effect.
Actos Side Effect Report#9691567
Ureteric Cancer
This report suggests a potential Actos Tablets 15 Ureteric Cancer side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actos Tablets 15 (dosage: 15 Mg, Qd) starting 2008. After starting Actos Tablets 15 the patient began experiencing various side effects, including: Ureteric CancerAdditional drugs used concurrently:
  • Basen Od Tablets 0.3 (0.3 Mg, Tid)
  • Olmetec (40 Mg, Qd)
  • Calblock (16 Mg, Qd)
  • Fluitran (0.5 Mg, Qd)
  • Crestor (2.5 Mg, Qd)
  • Lendormin D (0.25 Mg, Qd)
The patient was hospitalized. Although Actos Tablets 15 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ureteric Cancer, may still occur.
Actos Side Effect Report#9663923
Dyspnoea, Anaemia, Oedema, Weight Increased, Weight Loss Poor
This Dyspnoea problem was reported by a consumer or non-health professional from US. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On
Dec 01, 2000 this consumer started treatment with Actos (dosage: NA). The following drugs were being taken at the same time:
  • Glyburide
  • Metformin
  • Enalapril
  • Chlorthalidone
  • Crestor
  • Diltiazem
  • 81 Mg Aspirin
  • Levemir
When using Actos, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Anaemia, Oedema, Weight Increased, Weight Loss PoorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Actos Side Effect Report#9645721
Hypoglycaemia, Sopor
This Hypoglycaemia side effect was reported by a health professional from IT. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Actos (drug dosage: 1 Df, Qd), which was initiated on
Oct 16, 2013. Concurrently used drugs:
  • Gliclazide (240 Mg, Qd)
  • Gliclazide (240 Mg, Tid)
  • Methotrexate (10 Mg, Unk)
  • Acediur /00729601/
  • Deltacortene (6.12 Mg, Unk)
  • Folina /00024201/ (1 Df, Unk)
.After starting to take Actos the consumer reported adverse symptoms, such as: Hypoglycaemia, SoporThese side effects may potentially be related to Actos. The patient was hospitalized.
Actos Side Effect Report#9633431
Breast Cancer
This is a report of a 75-year-old female patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Actos (dosage: NA, start time:
Jul 15, 2007), combined with:
  • Crestor
  • Panadol Osteo
and developed a serious reaction and side effect(s): Breast Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos treatment in female patients, resulting in Breast Cancer side effect.
Actos Side Effect Report#9596919
Brain Natriuretic Peptide Increased, Oedema Peripheral, Dyspnoea
This report suggests a potential Actos Brain Natriuretic Peptide Increased side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Actos (dosage: 30 Mg, Qd) starting NS. After starting Actos the patient began experiencing various side effects, including: Brain Natriuretic Peptide Increased, Oedema Peripheral, DyspnoeaAdditional drugs used concurrently:
  • Unisia
  • Amaryl
  • Kerlong
  • Crestor
  • Bezatol
Although Actos demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Brain Natriuretic Peptide Increased, may still occur.
Actos Side Effect Report#9548740
Bladder Cancer
This Bladder Cancer problem was reported by a consumer or non-health professional from US. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Actos (dosage: 1 Pill; Once Daily ?4 Years 9 Months). The following drugs were being taken at the same time: NA. When using Actos, the patient experienced the following unwanted symptoms/side effects: Bladder CancerThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actos Side Effect Report#9515993
Bladder Cancer
This Bladder Cancer side effect was reported by a physician from TH. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Actos (drug dosage: NA), which was initiated on
Jan 23, 2012. Concurrently used drugs:
  • Utmos
  • Diamicron
  • Amaryl
  • Glucobay
  • Januvia
  • Glipizide
  • Erythropoetin Injection
  • Antibiotic
.After starting to take Actos the consumer reported adverse symptoms, such as: Bladder CancerThese side effects may potentially be related to Actos.
Actos Side Effect Report#9494355
Fall, Hip Fracture, Somnambulism
This is a report of a 52-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Actos (pioglitazone Hydrochloride) (dosage: NA, start time: 2005), combined with:
  • Omeprazole (omeprazole)
  • Plaviix (clopidogrel Bisulfate)
  • Verapamil (verapamil
  • Crestor (rosuvastatin Calcium)
  • Isosorbide (isosorbide)
  • Topamax (topiramate)
  • Hydrocodone And Acetaminoph (paracetmol, Hydrocodone Bitartrate) (tablets)
  • Ambien
and developed a serious reaction and side effect(s): Fall, Hip Fracture, Somnambulism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos (pioglitazone Hydrochloride) treatment in male patients, resulting in Fall side effect.
Actos Side Effect Report#9470303
Ureteric Cancer
This report suggests a potential Actos Ureteric Cancer side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actos (dosage: NA) starting
Jan 13, 2012. After starting Actos the patient began experiencing various side effects, including: Ureteric CancerAdditional drugs used concurrently:
  • Basen Od Tablets 0.3 (voglibose)
  • Olmetec (olmesartan Medoxoil)
  • Calblock (azelnidipine)
  • Fluitran (trichlormethiazide)
  • Crestor (rosuvastatin Calcium)
  • Lendormin D (bortizolam)
The patient was hospitalized. Although Actos demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ureteric Cancer, may still occur.
Actos Side Effect Report#9466438
Abdominal Discomfort, Nausea, Blood Pressure Increased, Vision Blurred
This Abdominal Discomfort problem was reported by a consumer or non-health professional from US. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Actos (dosage: NA). The following drugs were being taken at the same time:
  • Metformin Hcl 1000
When using Actos, the patient experienced the following unwanted symptoms/side effects: Abdominal Discomfort, Nausea, Blood Pressure Increased, Vision BlurredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Discomfort, may become evident only after a product is in use by the general population.
Actos Side Effect Report#9443388
Bladder Mass, Urinary Incontinence, Blood Glucose Increased, Injection Site Bruising
This Bladder Mass side effect was reported by a physician from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actos (drug dosage: NA), which was initiated on
Apr 27, 2007. Concurrently used drugs:
  • Rebif (3 In 1 Week, Subcutaneous)
  • Aspirin (acetylsalicylic Acid)
  • Phoslo (calcium Acetate)
  • Crestor (rosuvastatin Calcium)
  • Glucophage (metformin Hydrochloride)
  • Victoza (liraglutide)
.After starting to take Actos the consumer reported adverse symptoms, such as: Bladder Mass, Urinary Incontinence, Blood Glucose Increased, Injection Site BruisingThese side effects may potentially be related to Actos.
Actos Side Effect Report#9435497
Bladder Neoplasm, Gastric Ulcer, Haematemesis, Shock Haemorrhagic
This is a report of a 70-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Actos (dosage: 15 Mg ( 15 Mg, 1 In 1 D) Oral, start time:
Jan 06, 2010), combined with:
  • Pioglitazone Hydrochloride (15 Mg ( 15 Mg, 1 In 1 D) Oral)
  • Bayaspirin ( Acetylsalicylic Acid)
  • Adalat Cr ( Nifedipine)
  • Kalimate ( Calcium Polystyrene Sufonate)
  • Flivas ( Naftopidil)
  • Apidra ( Insulin Glulisine)
  • Lantus (insulin Glargine)
  • Lipacreon ( Pancrelipase)
and developed a serious reaction and side effect(s): Bladder Neoplasm, Gastric Ulcer, Haematemesis, Shock Haemorrhagic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos treatment in male patients, resulting in Bladder Neoplasm side effect.
Actos Side Effect Report#9434407
Hyperkalaemia
This report suggests a potential Actos Hyperkalaemia side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actos (dosage: NA) starting
Feb 21, 2009. After starting Actos the patient began experiencing various side effects, including: HyperkalaemiaAdditional drugs used concurrently:
  • Myslee (zolpidem Tartrate)
Although Actos demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperkalaemia, may still occur.
Actos Side Effect Report#9424500
Normochromic Normocytic Anaemia
This Normochromic Normocytic Anaemia problem was reported by a consumer or non-health professional from IT. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Aug 01, 2012 this consumer started treatment with Actos (dosage: NA). The following drugs were being taken at the same time:
  • Coumadin (warfarin Sodium)
  • Lasix (furosemide)
  • Lucen (esomeprazole Magnesium)
  • Aldactone (spironolactone)
  • Isoptin (verapamil Hydrochloride)
  • Adenuric
When using Actos, the patient experienced the following unwanted symptoms/side effects: Normochromic Normocytic AnaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Normochromic Normocytic Anaemia, may become evident only after a product is in use by the general population.
Actos Side Effect Report#9416683
Ankle Fracture, Intestinal Haemorrhage, Muscle Atrophy, Pain, Diabetes Mellitus Inadequate Control, Cough, Fall, Diabetic Neuropathy, Nasopharyngitis
This Ankle Fracture side effect was reported by a consumer or non-health professional from BR. A 90-year-old male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Actos (drug dosage: NA), which was initiated on 2001. Concurrently used drugs:
  • Puran T4 (levothyroxin Sodium)
  • Daflon (diogmin)
  • Daonil (glibenclamide)
  • Furosmide
  • Spironolactone
  • Allopurinol
  • Glifage Xr (metformin)
  • Pradaxa (dabigatran Etexilatr Mesilaye)
.After starting to take Actos the consumer reported adverse symptoms, such as: Ankle Fracture, Intestinal Haemorrhage, Muscle Atrophy, Pain, Diabetes Mellitus Inadequate Control, Cough, Fall, Diabetic Neuropathy, NasopharyngitisThese side effects may potentially be related to Actos. The patient was hospitalized.
Actos Side Effect Report#9416456
Renal Impairment, Fall, Humerus Fracture, Thermal Burn
This is a report of a 81-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Actos (pioglitazone Hydrochloride) (dosage: NA, start time:
Jun 08, 2011), combined with:
  • Mix (insulin Lispro, Insulin Lispro Promatine Suspension)
  • Seibule (miglitol)
  • Kinedak (epalarestato)
  • Poipan (camostat Mesilate)
  • Tsumura Goshajinkigan (herbal Extract)
  • Lyrica(pregamblin)
  • Lasix (furosemide)
  • Diovan (valsartan)
and developed a serious reaction and side effect(s): Renal Impairment, Fall, Humerus Fracture, Thermal Burn after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actos (pioglitazone Hydrochloride) treatment in male patients, resulting in Renal Impairment side effect. The patient was hospitalized.


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The appearance of Actos on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Actos reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Actos Side Effects

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    How Effective is Actos for You?

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    Actos Safety Alerts, Active Ingredients, Usage Information

    NDC0519-1322
    TypeHUMAN OTC DRUG
    Proprietary NameBactoshield CHG
    NameChlorhexidine Gluconate
    Dosage FormSOLUTION
    RouteTOPICAL
    On market since19991004
    LabelerSTERIS Corporation
    Active Ingredient(s)CHLORHEXIDINE GLUCONATE
    Strength(s)20
    Unit(s)mg/mL
    Pharma Class

    Actos Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3741

    Actos safety alerts: 2010 2007 2005 2002

    Reported deaths: 379

    Reported hospitalizations: 1902

    Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer

    [UPDATED 08/04/2011] The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

    [UPDATED 06/15/2011] Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

    This safety information is based on FDA's review of data from a five-year interim analysis of an ongoing, ten-year epidemiological study. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.

    FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.

    Additional Information for Patients, Information for Healthcare Professionals, and a Data Summary are provided in the Drug Safety Communication.

    FDA recommends that healthcare professionals should:

    • Not use pioglitazone in patients with active bladder cancer.
    • Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.

    FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.

     

    [Posted 09/17/2010]

    AUDIENCE: Endocrinology, Family Practice, Urology

    ISSUE: FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. At this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information.

    BACKGROUND: The drug manufacturer, Takeda, conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

    RECOMMENDATIONS: Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Actos. Patients should continue taking Actos unless told otherwise by their healthcare professional. Patients who are concerned about the possible risks associated with using Actos should talk to their healthcare professional.

    Additional Information for Patients, Information for Healthcare Professionals, and a Data Summary are provided in the Drug Safety Communication.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    [08/04/2011 - Drug Safety Communication - FDA]

    [06/15/2011 - Drug Safety Communication - FDA]

    [09/22/2010 - Podcast - FDA]
    [09/17/2010 - Drug Safety Communication - FDA]
    [09/17/2010 - Note To Correspondents - FDA]

     

     

     

    Latest Actos clinical trials