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Pioglitazone Side Effects

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Common Pioglitazone Side Effects


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

Cardiac Failure Congestive (52)
Bladder Cancer (43)
Fall (39)
Dyspnoea (35)
Oedema Peripheral (34)
Condition Aggravated (31)
Cardiac Failure (30)
Chest Pain (30)
Haematuria (28)
Nausea (24)
Blood Glucose Increased (24)
Dizziness (22)
Headache (20)
Atrial Fibrillation (19)
Anaemia (19)
Weight Increased (19)
Renal Failure Acute (18)
Bladder Transitional Cell Carcinoma (18)
Hypoglycaemia (17)
Asthenia (17)

➢ 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.

Pioglitazone Side Effects Reported to FDA



Pioglitazone Side Effect Report#9995569
Dizziness
This is a report of a 69-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Pioglitazone Tablets Usp (dosage: NA, start time:
Dec 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone Tablets Usp treatment in male patients, resulting in Dizziness side effect.
Pioglitazone Side Effect Report#9956330
Marasmus
This report suggests a potential Pioglitazone, Glimepiride Marasmus side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Pioglitazone, Glimepiride (dosage: 1 Df, Qd) starting
Dec 20, 2012. After starting Pioglitazone, Glimepiride the patient began experiencing various side effects, including: MarasmusAdditional drugs used concurrently:
  • Glactiv (50 Mg, 1 Days)
  • Renivace (Unk)
  • Fluitran (Unk)
  • Crestor (Unk)
  • Nexium /01479302/ (Unk)
  • Evista (Unk)
Although Pioglitazone, Glimepiride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Marasmus, may still occur.
Pioglitazone Side Effect Report#9925864
Lung Neoplasm Malignant
This Lung Neoplasm Malignant problem was reported by a physician from JP. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Oct 28, 2011 this consumer started treatment with Pioglitazone, Glimepiride (dosage: 1 Df, Qd). The following drugs were being taken at the same time:
  • Blopress (Unk)
  • Caduet (Unk)
  • Anplag (Unk)
When using Pioglitazone, Glimepiride, the patient experienced the following unwanted symptoms/side effects: Lung Neoplasm MalignantAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lung Neoplasm Malignant, may become evident only after a product is in use by the general population.
Pioglitazone Side Effect Report#9922608
Bronchitis
This Bronchitis side effect was reported by a physician from JP. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Pioglitazone, Glimepiride (drug dosage: 1 Df, Qd), which was initiated on
Nov 30, 2012. Concurrently used drugs:
  • Lipovas /00848101/ (Unk)
  • Exforge (Unk)
  • Cardenalin (Unk)
  • Selara (Unk)
  • Rinderon-vg (Unk)
.After starting to take Pioglitazone, Glimepiride the consumer reported adverse symptoms, such as: BronchitisThese side effects may potentially be related to Pioglitazone, Glimepiride.
Pioglitazone Side Effect Report#9912226
Cardiac Failure Congestive, Dyspnoea
This is a report of a 57-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pioglitazone (dosage: Unk, start time: NS), combined with:
  • Metformin (Unk)
  • Bisoprolol (Unk)
  • Candesartan (Unk)
  • Spironolactone (Unk)
and developed a serious reaction and side effect(s): Cardiac Failure Congestive, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone treatment in male patients, resulting in Cardiac Failure Congestive side effect. The patient was hospitalized.
Pioglitazone Side Effect Report#9912064
Cardiac Failure Congestive, Dyspnoea
This report suggests a potential Pioglitazone Cardiac Failure Congestive side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Pioglitazone (dosage: NA) starting NS. After starting Pioglitazone the patient began experiencing various side effects, including: Cardiac Failure Congestive, DyspnoeaAdditional drugs used concurrently:
  • Metformin
  • Bisoprolol
  • Candesartan
  • Spironolactone
The patient was hospitalized. Although Pioglitazone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Congestive, may still occur.
Pioglitazone Side Effect Report#9900153
Cerebrovascular Accident
This Cerebrovascular Accident problem was reported by a physician from JP. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jun 07, 2012 this consumer started treatment with Pioglitazone, Glimepiride (dosage: 1 Df, Qd). The following drugs were being taken at the same time:
  • Atorvastatin /01326102/ (Unk)
  • Imidapril Hydrochloride (Unk)
When using Pioglitazone, Glimepiride, the patient experienced the following unwanted symptoms/side effects: Cerebrovascular AccidentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebrovascular Accident, may become evident only after a product is in use by the general population.
Pioglitazone Side Effect Report#9892215
Myocardial Infarction
This Myocardial Infarction side effect was reported by a physician from JP. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Pioglitazone (drug dosage: 15 Mg,1 Days), which was initiated on
Aug 27, 2009. Concurrently used drugs:
  • Blopress (Unk)
  • Humalog (31 Ut, Tid)
  • Humalog (20 Iu, Bid)
  • Humalog (16 Iu, Bid)
  • Humalog (14 Iu, Bid)
  • Humalog Mix 50 (11 Ut, Qd)
  • Humalog Mix 50 (13 Ut, Qd)
  • Zyloric (Unk)
.After starting to take Pioglitazone the consumer reported adverse symptoms, such as: Myocardial InfarctionThese side effects may potentially be related to Pioglitazone. The patient was hospitalized.
Pioglitazone Side Effect Report#9892214
Type 1 Diabetes Mellitus
This is a report of a 35-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Pioglitazone (dosage: 15 Mg,1 Days, start time:
Sep 30, 2012), combined with:
  • Novolin R (28 Ut, Tid)
  • Levemir (24 Ut, Qd)
and developed a serious reaction and side effect(s): Type 1 Diabetes Mellitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone treatment in female patients, resulting in Type 1 Diabetes Mellitus side effect. The patient was hospitalized.
Pioglitazone Side Effect Report#9884560
Haematuria, Bladder Cancer
This report suggests a potential Pioglitazone Haematuria side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: diabetes mellitus and used Pioglitazone (dosage: 15 Mg, Qd) starting 201108. After starting Pioglitazone the patient began experiencing various side effects, including: Haematuria, Bladder CancerAdditional drugs used concurrently:
  • Simvastatin
  • Ramipril
  • Omeprazole
  • Metformin (1 G, Bid)
  • Gliclazide (160 Mg, Bid)
  • Dipyridamole
  • Bezafibrate
  • Aspirin
Although Pioglitazone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematuria, may still occur.
Pioglitazone Side Effect Report#9868609
Bile Duct Obstruction, Jaundice
This Bile Duct Obstruction problem was reported by a physician from JP. A 85-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jul 21, 2010 this consumer started treatment with Pioglitazone, Glimepiride (dosage: 1 Df, Qd). The following drugs were being taken at the same time:
  • Basen (0.6 Mg, 1 Days)
  • Glactiv (50 Mg, 1 Days)
  • Amaryl (1 Mg, Qd)
  • Aricept (Unk)
  • Epadel-s (Unk)
  • Chotosan (Unk)
  • Chotosan
When using Pioglitazone, Glimepiride, the patient experienced the following unwanted symptoms/side effects: Bile Duct Obstruction, JaundiceThe 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 Bile Duct Obstruction, may become evident only after a product is in use by the general population.
Pioglitazone Side Effect Report#9850836
Hepatic Function Abnormal
This Hepatic Function Abnormal side effect was reported by a physician from JP. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Pioglitazone (drug dosage: 15 Mg, 1 Days), which was initiated on
Jan 25, 2010. Concurrently used drugs:
  • Novorapid 30 Mix Flexpen (64 Iu, Bid)
  • Novorapid 30 Mix Flexpen (20 Iu, Tid)
  • Novorapid 30 Mix Flexpen (64 Iu, Tid)
  • Novorapid 30 Mix Flexpen (30 Iu, Qd)
  • Novorapid 70 Mix Flexpen (20 Iu, Bid)
  • Melbin /00082702/ (Unk)
  • Plavix (Unk)
  • Lasix /00032601/ (Unk)
.After starting to take Pioglitazone the consumer reported adverse symptoms, such as: Hepatic Function AbnormalThese side effects may potentially be related to Pioglitazone.
Pioglitazone Side Effect Report#9842983
Oesophageal Carcinoma
This is a report of a 81-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Pioglitazone, Glimepiride (dosage: 1 Df, Qd, start time:
Jan 08, 2013), combined with:
  • Harnal (Unk)
and developed a serious reaction and side effect(s): Oesophageal Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone, Glimepiride treatment in male patients, resulting in Oesophageal Carcinoma side effect. The patient was hospitalized.
Pioglitazone Side Effect Report#9834151
Cardiac Failure Congestive, Hyponatraemia, Pleural Effusion, Aortic Stenosis, Fluid Overload, Oedema Peripheral
This report suggests a potential Pioglitazone Cardiac Failure Congestive side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Pioglitazone (dosage: 45 Mg, Qd) starting NS. After starting Pioglitazone the patient began experiencing various side effects, including: Cardiac Failure Congestive, Hyponatraemia, Pleural Effusion, Aortic Stenosis, Fluid Overload, Oedema PeripheralAdditional drugs used concurrently:
  • Amlodipine (5 Mg, Qd)
  • Tamsulosin (400 ?g, Qd)
  • Metformin (850 Mg, Bid)
  • Bimatoprost (100mcg/ml 1 Drop At Night Both Eyes)
  • Atorvastatin (20 Mg, Qd)
  • Aspirin (75 Mg, Qd)
The patient was hospitalized. Although Pioglitazone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Congestive, may still occur.
Pioglitazone Side Effect Report#9832904
Cardiac Failure Congestive, Hyponatraemia, Pleural Effusion, Aortic Stenosis, Fluid Overload, Oedema Peripheral
This Cardiac Failure Congestive problem was reported by a pharmacist from GB. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Pioglitazone (dosage: NA). The following drugs were being taken at the same time:
  • Amlodipine (5 Milligram Daily;)
  • Tamsulosin (400 Microgram Daily;)
  • Metformin (1700 Milligram Daily;)
  • Bimatoprost (1 Dosage Forms Daily; 100mcg/ Ml. 1 Drop At Night Both Eyes.)
  • Atorvastatin (20 Milligram Daily; Taken At Night.)
  • Aspirin (75 Milligram Daily;)
When using Pioglitazone, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure Congestive, Hyponatraemia, Pleural Effusion, Aortic Stenosis, Fluid Overload, Oedema PeripheralThe 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 Cardiac Failure Congestive, may become evident only after a product is in use by the general population.
Pioglitazone Side Effect Report#9822611
Hyponatraemia, Pleural Effusion, Aortic Stenosis, Fluid Overload, Oedema Peripheral, Cardiac Failure Congestive
This Hyponatraemia side effect was reported by a health professional from GB. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pioglitazone (drug dosage: 45 Mg, Qd), which was initiated on NS. Concurrently used drugs:
  • Amlodipine (5 Mg, Qd)
  • Tamsulosin (400 Ug, Qd)
  • Metformin (850 Mg, Bid)
  • Bimatoprost (1 Df, Qd, 100mcg/ Ml. 1 Drop At Night Both Eyes)
  • Atorvastatin (20 Mg, Qd, Taken At Night)
  • Aspirin (75 Mg, Qd)
.After starting to take Pioglitazone the consumer reported adverse symptoms, such as: Hyponatraemia, Pleural Effusion, Aortic Stenosis, Fluid Overload, Oedema Peripheral, Cardiac Failure CongestiveThese side effects may potentially be related to Pioglitazone. The patient was hospitalized.
Pioglitazone Side Effect Report#9817330
Cardiac Failure Congestive, Pleural Effusion, Hyponatraemia, Fluid Overload, Aortic Stenosis, Oedema Peripheral
This is a report of a 74-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pioglitazone (dosage: 45 Mg, Daily, start time: NS), combined with:
  • Amlodipine (5 Mg, Daily)
  • Aspirin (75 Mg, Daily)
  • Tamsulosin (400 ?g, Daily)
  • Metformin (850 Mg, Bid)
  • Bimatoprost (1 Df, Daily)
  • Atorvastatin (20 Mg, Daily)
and developed a serious reaction and side effect(s): Cardiac Failure Congestive, Pleural Effusion, Hyponatraemia, Fluid Overload, Aortic Stenosis, Oedema Peripheral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone treatment in male patients, resulting in Cardiac Failure Congestive side effect. The patient was hospitalized.
Pioglitazone Side Effect Report#9813599
Prostate Cancer
This report suggests a potential Pioglitazone, Glimepiride Prostate Cancer side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Pioglitazone, Glimepiride (dosage: 1 Df, Qd) starting
Nov 29, 2011. After starting Pioglitazone, Glimepiride the patient began experiencing various side effects, including: Prostate CancerAdditional drugs used concurrently:
  • Blopress (Unk)
  • Januvia (50 Mg, 1 Days)
  • Livalo (Unk)
  • Harnal D (Unk)
  • Lendormin Dainippo (Unk)
  • Yodel-s (Unk)
  • New Lecicarbon (Unk)
  • Celestamine /00252801/ (Unk)
Although Pioglitazone, Glimepiride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Prostate Cancer, may still occur.
Pioglitazone Side Effect Report#9813596
Road Traffic Accident
This Road Traffic Accident problem was reported by a physician from JP. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jan 19, 2012 this consumer started treatment with Pioglitazone, Glimepiride (dosage: 1 Df, Qd). The following drugs were being taken at the same time:
  • Januvia (50 Mg, 1 Days)
  • Mucodyne (Unk)
  • Tricor /00499301/ (Unk)
  • Prednisolone (Unk)
When using Pioglitazone, Glimepiride, the patient experienced the following unwanted symptoms/side effects: Road Traffic AccidentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Road Traffic Accident, may become evident only after a product is in use by the general population.
Pioglitazone Side Effect Report#9799018
Hepatotoxicity
This Hepatotoxicity side effect was reported by a physician from GB. A 49-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pioglitazone (drug dosage: NA), which was initiated on 201305. Concurrently used drugs:
  • Aripiprazole (aripiprazole)
  • Metformin
  • Olanzapine
  • Paroxetine
  • Simvastatin
.After starting to take Pioglitazone the consumer reported adverse symptoms, such as: HepatotoxicityThese side effects may potentially be related to Pioglitazone.
Pioglitazone Side Effect Report#9792962
Acute Pulmonary Oedema
This is a report of a 61-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pioglitazone (dosage: NA, start time: NS), combined with:
  • Glipizide (160 Mg, Bid)
  • Thyroxine (125 ?g, Qd)
  • Atorvastatin (10 Mg, Qd)
and developed a serious reaction and side effect(s): Acute Pulmonary Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone treatment in female patients, resulting in Acute Pulmonary Oedema side effect. The patient was hospitalized.
Pioglitazone Side Effect Report#9792960
Acute Pulmonary Oedema
This report suggests a potential Pioglitazone Acute Pulmonary Oedema side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Pioglitazone (dosage: NA) starting NS. After starting Pioglitazone the patient began experiencing various side effects, including: Acute Pulmonary OedemaAdditional drugs used concurrently:
  • Glipizide (10 Mg, Bid)
  • Lisinopril (10 Mg, Qd)
The patient was hospitalized. Although Pioglitazone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Pulmonary Oedema, may still occur.
Pioglitazone Side Effect Report#9773315
Renal Failure Acute, Renal Impairment, Liver Function Test Abnormal
This Renal Failure Acute problem was reported by a pharmacist from GB. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 06, 2013 this consumer started treatment with Pioglitazone (dosage: NA). The following drugs were being taken at the same time:
  • Adcal D3
  • Anastrozole
  • Furosemide
  • Glucobay
  • Perindopril
When using Pioglitazone, the patient experienced the following unwanted symptoms/side effects: Renal Failure Acute, Renal Impairment, Liver Function Test AbnormalThe 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 Renal Failure Acute, may become evident only after a product is in use by the general population.
Pioglitazone Side Effect Report#9769399
Diarrhoea, Abdominal Pain Upper, Diarrhoea
This Diarrhoea side effect was reported by a physician from GB. A 58-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pioglitazone (drug dosage: NA), which was initiated on
Sep 30, 2013. Concurrently used drugs:
  • Humulin
  • Amitriptyline Hydrochloride
  • Amlodipine
  • Asacol
  • Bendroflumethiazide
  • Bisoprolol
  • Co-codamol
  • Doxazosin
.After starting to take Pioglitazone the consumer reported adverse symptoms, such as: Diarrhoea, Abdominal Pain Upper, DiarrhoeaThese side effects may potentially be related to Pioglitazone.
Pioglitazone Side Effect Report#9769252
Renal Impairment, Renal Failure Acute, Hepatic Function Abnormal
This is a report of a 75-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pioglitazone (pioglitazone) (dosage: NA, start time:
Nov 06, 2013), combined with:
  • Adcal-d3 (lekovit Ca)
  • Anastrozole (anastrozole)
  • Furosemide (furosemide)
  • Glucobay
  • Perindopril Erbumine (perindopril Erbumine)
and developed a serious reaction and side effect(s): Renal Impairment, Renal Failure Acute, Hepatic Function Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pioglitazone (pioglitazone) treatment in female patients, resulting in Renal Impairment side effect. The patient was hospitalized.


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The appearance of Pioglitazone 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.

What are common Pioglitazone Side Effects for Women?

Women Side EffectsReports
Chest Pain 22
Fall 21
Cardiac Failure 17
Dyspnoea 16
Headache 15
Cardiac Failure Congestive 14
Condition Aggravated 13
Renal Failure Acute 13
Oedema Peripheral 12
Blood Glucose Increased 11

What are common Pioglitazone Side Effects for Men?

Men Side EffectsReports
Cardiac Failure Congestive 37
Bladder Cancer 35
Haematuria 24
Oedema Peripheral 22
Dyspnoea 19
Bladder Transitional Cell Carcinoma 18
Condition Aggravated 18
Fall 17
Anaemia 14
Dizziness 14

Track Your Side Effects

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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.

    Pioglitazone 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 Pioglitazone Side Effects

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    How Effective is Pioglitazone for You?

    Exceeded Expectations
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    Pioglitazone Safety Alerts, Active Ingredients, Usage Information

    NDC0093-2046
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePioglitazone
    Namepioglitazone
    Dosage FormTABLET
    RouteORAL
    On market since20120817
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)PIOGLITAZONE HYDROCHLORIDE
    Strength(s)45
    Unit(s)mg/1
    Pharma ClassPeroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist

    More About Pioglitazone

    Side Effects reported to FDA: 653

    Pioglitazone safety alerts: 2010 2007 2002

    Reported deaths: 47

    Reported hospitalizations: 248

    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]

     

     

     

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