1. Classification of the incidence of adverse events (WHO):
very often> 1/10
often from> 1/100 to <1/10
infrequently from> 1/1000 to <1/100
rarely from> 1/10000 to <1/1000
very rarely from <1/10000, including individual messages.
Monotherapy with pioglitazone:
From the sense organs: often - visual impairment.
From the respiratory system: often - infections of the upper respiratory tract; infrequently sinusitis.
From the side of metabolism: often - weight gain.
From the nervous system: often - hypoesthesia; infrequently - insomnia. Combination of pioglitazone with metfovamine:
From the hematopoiesis: often anemia.
From the sense organs: often - visual impairment.
From the digestive system: infrequently - flatulence.
From the side of metabolism: often - weight gain.
From the musculoskeletal system: often - arthralgia.
From the nervous system: often a headache.
From the genitourinary system: often - hematuria, erectile dysfunction.
Combination of pioglitazone with sulfonylurea derivatives:
From the sense organs: infrequently - vertigo, impaired vision.
From the digestive system: often - flatulence.
Other: infrequently, fatigue.
From the side of metabolism: often - weight gain; infrequently - increased lactate dehydrogenase (LDH) activity, increased appetite, hypoglycemia.
From the nervous system: often - dizziness; infrequently - a headache.
From the genitourinary system: infrequently - glycosuria, proteinuria.
From the skin: infrequently - increased sweating. Combination of pioglitazone with metformin and sulfonylurea derivatives:
From the side of metabolism: very often - hypoglycemia; often - increased body weight, increased activity of creatine phosphokinase (CK).
From the musculoskeletal system: often - arthralgia.
Combination of pioglitazone with insulin:
From the side of metabolism: often - hypoglycemia.
From the musculoskeletal system: often - back pain, arthralgia.
From the respiratory system: often shortness of breath, bronchitis.
From the cardiovascular system: often - heart failure.
Other: very often - swelling.
Post-marketing experience:
From the sense organs: very rarely - edema of the macula, fracture of bones.
With long-term use of pioglitazone over 1 year in 6-9% of cases, patients experience edema, mild or moderate, and usually do not require discontinuation of therapy.
Visual disturbances appear primarily at the beginning of therapy and are associated with a change in the concentration of glucose in the blood plasma, as well as when taking other hypoglycemic agents.
Benign and malignant tumors: infrequently - bladder cancer.