N Engl J Med 355:22972307 Aithal GP, Thomas JA, Kaye PV et al (2008) Randomized, placebo-controlled trial of pioglitazone in nondiabetic subjects with nonalcoholic steatohepatitis
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Adverse Reactions/Side Effects The following clinically significant adverse reactions are described elsewhere in the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.6)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2)] Risk of Ophthalmologic Adverse Reactions [see Warnings and Precautions (5.3)] Mood and Sleep Disorders [see Warnings and Precautions (5.4)] Cognitive Impairment [see Warnings and Precautions (5.5)] Slowing of Linear Growth [see Warnings and Precautions (5.6)] Metabolic Acidosis [see Warnings and Precautions (5.7)] Decrease in Renal Function [see Warnings and Precautions (5.8)] Risk of Seizures with Abrupt Withdrawal of QSYMIA [see Warnings and Precautions (5.9)] Kidney Stones [see Warnings and Precautions (5.10)] Oligohydrosis and Hyperthermia [see Warnings and Precautions (5.11)] Hypokalemia [see Warnings and Precautions (5.12)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [ see Warnings and Precautions (5.13)] Serious Skin Reactions [see Warnings and Precautions (5.14)] Anaphylaxis and Angioedema [see Warnings and Precautions (5.15)] Allergic Reactions Due to Inactive Ingredient FD&C Yellow No

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