The data are presented on the basis of the classification of organ systems by MedDRA (medical dictionary for regulatory activities). Consideration should be given to previously known side effects and other conditions associated with the use of Bonefos ®. The incidence of side effects is defined as: often> 1% and <10% (1/100 of prescriptions), rarely> 0.01% and <0.1% (1/10000 prescriptions).
Metabolic disorders: often asymptomatic hypocalcemia; rarely - hypocalcemia accompanied by clinical manifestations; increase in the concentration of parathyroid hormone in the serum (associated with a decrease in serum calcium concentration),increased serum alkaline phosphatase concentrations (in patients with metastases, the activity of alkaline phosphatase may also increase due to the presence of metastases in the liver and bones).
Disorders from the gastrointestinal tract: often - diarrhea *, nausea *, vomiting *.
Disorders from the liver and bile ducts: often - increased transaminases are usually within normal limits; rarely - an increase in transaminases in 2 times, in comparison with the norm, without disturbing the liver function.
Disturbances from the skin and its appendages: rarely - reactions of increased sensitivity, manifested as skin reactions.
* usually in a light form.
Adverse reactions reported in the post-marketing application of the drug:
Disorders from the organs of vision: the occurrence of uveitis in patients receiving the preparation Bonefoe®. Conjunctivitis, episcleritis, scleritis against the background of therapy with other bisphosphonates. The emergence of conjunctivitis was observed only in one patient who took the preparation Bonefos ® simultaneously with another bisphosphonate. The incidence of episcleritis and scleritis against the background of therapy with Bonefos ® was not detected.
From the respiratory system: in patients with bronchial asthma, increased sensitivity to acetylsalicylic acid in history, there were violations of respiratory function, bronchospasm.
From the side of the kidneys and urinary tract: impaired renal function (increased serum creatinine and proteinuria), severe renal failure, especially after rapid IV administration of clodronic acid in high doses.
Single cases of renal failure, incl. with a fatal outcome, especially with simultaneous application with NSAIDs, most often - with diclofenac.
From the musculoskeletal and connective tissue: isolated reports of osteonecrosis of the jaw, mainly in patients who received previous therapy with aminobisphosphonates, such as zoledronic acid and pamidronic acid. There have been reports of cases of severe pain in the bones, joints and / or muscles in patients taking Bonnefos®. However, such reports were infrequent and, according to randomized clinical trials, there was no difference in the incidence of these events in patients taking Bonefos® and in patients in the placebo group.Similar symptoms developed several days or several months after the start of Bonefos®.
During the postmarketing use of other bisphosphonates, the following adverse reactions were reported: an atypical fracture-prone femur and a fracture of the femoral diaphysis. On the background of therapy with Bonefos ®, no adverse reactions were noted