Jump To


  • Generic Name: uptravi selexipag tablets
  • Brand Name: Uptravi
  • Drug Class: PAH, Prostacyclin Agonists
Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/5/2021


Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of UPTRAVI has been evaluated in a long-term, placebo-controlled study enrolling 1156 patients with symptomatic PAH (GRIPHON study). The exposure to UPTRAVI in this trial was up to 4.2 years with median duration of exposure of 1.4 years.

Table 1 presents adverse reactions more frequent on UPTRAVI than on placebo by ≥3%.

Table 1 Adverse Reactions

Adverse Reaction UPTRAVI Placebo
N=575 N=577
Headache 65% 32%
Diarrhea 42% 18%
Jaw pain 26% 6%
Nausea 33% 18%
Myalgia 16% 6%
Vomiting 18% 9%
Pain in extremity 17% 8%
Flushing 12% 5%
Arthralgia 11% 8%
Anemia 8% 5%
Decreased appetite 6% 3%
Rash 11% 8%


These adverse reactions are more frequent during the dose titration phase.

Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI and in none of the patients on placebo.

Laboratory Test Abnormalities


In a Phase 3 placebo-controlled study in patients with PAH, mean absolute changes in hemoglobin at regular visits compared to baseline ranged from −0.34 to −0.02 g/dL in the selexipag group compared to −0.05 to 0.25 g/dL in the placebo group. A decrease in hemoglobin concentration to below 10 g/dL was reported in 8.6% of patients treated with selexipag and 5.0% of placebo-treated patients.

Thyroid Function Tests

In a Phase 3 placebo-controlled study in patients with PAH, a reduction (up to −0.3 MU/L from a baseline median of 2.5 MU/L) in median thyroid-stimulating hormone (TSH) was observed at most visits in the selexipag group. In the placebo group, little change in median values was apparent. There were no mean changes in triiodothyronine or thyroxine in either group.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Uptravi. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Symptomatic hypotension.



Read Next Article

PHP Code Snippets Powered By : XYZScripts.com