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Adverse Reactions

The safety of Teriparatide has been evaluated in 24 clinical trials that enrolled over 2800 women and men. Four long-term, Phase 3 clinical trials included one large placebo-controlled, double-blind multicentre trial with 1637 postmenopausal women, one placebo-controlled, double-blind multicentre trial with 437 men, and two active-controlled trials including 393 postmenopausal women. Teriparatide doses ranged from 5 to 100 mcg/day in short-term trials and 20 to 40 mcg/day in the long-term trials. A total of 1943 of the patients studied received Teriparatide, including 815 patients at 20 mcg/day and 1107 patients at 40 mcg/day. In the long-term clinical trials, 1137 patients were exposed to Teriparatide for greater than 1 year (500 at 20 mcg/day and 637 at 40 mcg/day). The maximum exposure duration to Teriparatide was 2 years. Adverse events associated with Teriparatide (rDNA origin) injection usually were mild and generally did not require discontinuation of therapy.

The safety of Teriparatide has also been evaluated in a Phase 3 randomized, double blind, double-dummy, active controlled clinical trial that enrolled 428 men and women with glucocorticoid induced osteoporosis. Patients received either Teriparatide 20 mcg/day plus oral placebo (n=214) or Alendronate 10 mg/day plus injectable placebo (n=214).

Adverse Events in Placebo-Controlled Clinical Trials (Irrespective of Causality)a

Body System / Adverse events % of patients
Terifrac (N=691) Placebo (N=691)
Body as a whole
Pain 21.3 20.5
Headache 7.5 7.4
Asthenia 8.7 6.8
Neck Pain 3.0 2.7
Cardiovascular
Hypertension 7.1 6.8
Angina Pectoris 2.5 1.6
Syncope 2.6 1.4
Digestive system
Nausea 8.5 6.7
Constipation 5.4 4.5
Diarrhea 5.1 4.6
Dyspepsia 5.2 4.1
Vomiting 3.0 2.3
Gastrointestinal Disorder 2.3 2.0
Tooth disorder 2.0 1.3
Metabolic
Hyperuricemia 2.8 0.7
Musculoskeletal
Arthralgia 10.1 8.4
Leg Cramps 2.6 1.3
Nervous system
Dizziness 8.0 5.4
Depression 4.1 2.7
Insomnia 4.3 3.6
Vertigo 3.8 2.7
Respiratory system
Rhinitis 9.6 8.8
Cough Increasesd 6.4 5.5
Pharyngitis 5.5 4.8
Dyspnea 3.6 2.6
Pneumonia 3.9 3.3
Skin and appendages
Rash 4.9 4.5
Sweating 2.2 1.7
aTreatment emergent adverse events that occurred at a frequency ≥ 2% in patients treated with TERIFRAC at 20 mcg/day irrespective of causality assessment by Clinical Study Investigators. COSTART terminology.

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