General security profile When treating teriparatide, the most frequent adverse reactions were pain in the limbs, nausea, headache and dizziness.
In clinical studies of teriparatide, at least one adverse event was reported in 82.8% of patients in the teriparatide therapy group and 84.5% in the placebo group.
Adverse events identified during clinical trials research and post-marketing studies of teriparatide are reflected below with frequency division: very frequent (> 10%), frequent (> 1% to <10%), infrequent (> 0,1% to <1%), rare (> 0, 01% to <0.1%), very rare (<0.01%).
Violations of the blood and lymphatic system Often (from> 1% to <10%): anemia.
Immune system disorders
Rarely (> 0.01% to <0.1%): anaphylaxis
| Disorders from the metabolism and nutrition | Often (from | >1% | before | <10%): | | hypercholesterolemia. |
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| | Infrequently (from | >0,1% | before | <1%): | | hypercalcemia | higher | 2,76 | mmol / l. | | hyperuricemia. Rarely (from | >0,01% | BEFORE | <0,1%): | |
hypercalcemia is higher than 3.25 mmol / l. Disorders of the psyche Often (from> 1% to <10%): depression. Disturbances from the nervous system Often (> 1% to <10%): dizziness, headache, sciatica, faint. Hearing disorders and labyrinthine disorders Often (from> 1% to <10%): vertigo.
Heart Disease
Often (from> 1% to <10%): a feeling of palpitations. Infrequently (from> 0.1% to <1%): tachycardia.
Vascular disorders
| Often (from> 1% to <10%): lowering blood pressure. Disturbances from the respiratory system, chest and mediastinal organs Often (from> 1% to <10%): shortness of breath. Infrequently (from> 0.1% to <1%): emphysema. Disorders from the gastrointestinal tract Often (> 1% to <10%): nausea, vomiting, hiatal hernia, gastroesophageal reflux disease. Infrequently (from> 0,1% to <1%): hemorrhoids. Disturbances from the skin and subcutaneous tissues Often (from> 1% to <10%): increased sweating. Disturbances from musculoskeletal and connective tissue Very often (> 10%): pain in the limbs. Often (from> 1% to <10%): muscle cramps. Infrequent (> 0,1% to <1%): myalgia, arthralgia, pain or spasm in the back *. Disorders from the nochek and urinary tract Infrequent (> 0,1% to <1%): urinary incontinence, polyuria, mandatory urges to urinate, urolithiasis. Rarely (> 0.01% to <0.1%): renal impairment / renal insufficiency. General disorders and disorders at the site of administration Often (> 1% to <10%): fatigue, asthenia, mild and transient phenomena at the injection site, such as pain, swelling, erythema, itching, bruising and minor bleeding at the injection site. Infrequent (> 0,1% to <1%): reaction at the injection site, erythema at the injection site. Rarely (> 0.01% to <0.1%): allergic reactions shortly after injection: acute dyspnea, edema of the mouth / face, urticaria, chest pain, swelling (mainly peripheral). Laboratory and instrumental data |
Infrequently (from> 0.1% to <1%): increase body mass, noise in the heart, increased concentration of alkaline phosphatase. Severe cases of cramps or back pain were noted within a few minutes after the injection.
Description of individual reactions The following phenomena occurred in clinical studies in the teriparatide group with a frequency> 1% compared with the placebo group: vertigo, nausea, pain in the extremities, dizziness, depression, dyspnea.
When using teriparatide, it is possible to increase the concentration of uric acid in the blood serum.According to clinical data, 2.8% of patients in the teriparatide group had a higher urinary acid concentration than the upper limit of normal, compared with 0.7% of patients in the placebo group. Nevertheless, an increase in the concentration of uric acid in the blood did not adversely affect the course of gout, arthralgia or urolithiasis.
In large clinical trials, 2.8% of patients had antibodies with cross-reactivity with teriparatide. As a rule, antibodies appeared after 12 months of therapy and disappeared after discontinuation of therapy. In connection with the appearance of antibodies, there were no signs of hypersensitivity reaction, allergic reactions, influence on calcium concentration or influence on the therapeutic response with respect to bone mineral density.