Of patients in the teriparatide trials, 82.8% of the FORTEO patients and 84.5% of the placebo patients reported at least 1 adverse event.
The most commonly reported adverse events in patients treated with FORTEO are nausea, pain in limb, headache and dizziness.
The following table of adverse reactions is observed from clinical trials and post-marketing spontaneous reports.
Frequency estimate: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 2.)
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FORTEO increases serum uric acid concentrations. In clinical trials, 2.8% of FORTEO patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients. However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis.
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving FORTEO. Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy. There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on BMD response.