Pioglitazone Hydrochloride

Pioglitazone Hydrochloride

Pioglitazone Hydrochloride Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Monotherapy and Combination Therapy

Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].

Important Limitation of Use

Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

Use caution in patients with liver disease [see Warnings and Precautions (5.3)].


There is currently no drug history available for this drug.

Other Information

Pioglitazone tablets USP (pioglitazone hydrochloride) are an oral antidiabetic medication.

Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:

pioglitazone hydrochloride structural formula

Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons. It is soluble in N, N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.

Pioglitazone tablets USP are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, carboxymethylcellulose calcium, hydroxypropylcellulose, and magnesium stearate.

Pioglitazone Hydrochloride Manufacturers

  • American Health Packaging
    Pioglitazone Hydrochloride Tablet [American Health Packaging]
  • Accord Healthcare Inc.
    Pioglitazone Hydrochloride Tablet [Accord Healthcare Inc.]
  • Breckenridge Pharmaceutical, Inc.
    Pioglitazone Hydrochloride Tablet [Breckenridge Pharmaceutical, Inc.]
  • Golden State Medical Supply
    Pioglitazone Hydrochloride Tablet [Golden State Medical Supply]
  • American Health Packaging
    Pioglitazone Hydrochloride Tablet [American Health Packaging]
  • American Health Packaging
    Pioglitazone Hydrochloride Tablet [American Health Packaging]
  • Dispensing Solutions, Inc.
    Pioglitazone Hydrochloride Tablet [Dispensing Solutions, Inc.]
  • Gen-source Rx
    Pioglitazone Hydrochloride Tablet [Gen-source Rx]
  • Aurobindo Pharma Limited
    Pioglitazone Hydrochloride Tablet [Aurobindo Pharma Limited]
  • Actavis Pharma, Inc.
    Pioglitazone Hydrochloride Tablet [Actavis Pharma, Inc.]

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