Tell your doctor all medications and supplements you use.
Adempas During Pregnancy and Breastfeeding
Adempas is not recommended for use during pregnancy. It may harm a fetus. For women, Adempas is only available through the Adempas REMS Program and women must comply with pregnancy testing and contraception requirements. Consult your doctor for details. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Adempas (riociguat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Adempas Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using riociguat and call your doctor at once if you have:
a light-headed feeling, like you might pass out;
abnormal vaginal bleeding, or any other unusual bleeding;
vomiting or coughing up bright red blood, or vomit that looks like coffee grounds;
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
build-up of fluid in your lungs--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.
Common side effects may include:
headache, dizziness;
indigestion, nausea, vomiting, diarrhea; or
swelling in your hands, legs, or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 data described below reflect exposure to Adempas in two, randomized, double blind, placebo-controlled trials in patients with inoperable or recurrent/persistent CTEPH (CHEST-1) and treatment naive or pre-treated PAH patients (PATENT-1). The population (Adempas: n = 490; Placebo: n = 214) was between the age of 18 and 80 years [see Clinical Studies].
The safety profile of Adempas in patients with inoperable or recurrent/persistent CTEPH (CHEST-1) and treatment naive or pre-treated PAH (PATENT-1) were similar. Therefore, adverse drug reactions (ADRs) identified from the 12 and 16 week placebo-controlled trials for PAH and CTEPH respectively were pooled, and those occurring more frequently on Adempas than placebo (≥3%) are displayed in Table 1 below. Most adverse reactions in Table 1 can be ascribed to the
vasodilatory mechanism of action of Adempas.
The overall rates of discontinuation due to an adverse event in the pivotal placebo-controlled trials were 2.9% for Adempas and 5.1% for placebo (pooled data).
Table 1: Adverse Reactions Occurring More Frequently (≥3%) on Adempas than Placebo (Pooled from CHEST-1 and PATENT-1)
Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were: palpitations, nasalcongestion, epistaxis, dysphagia, abdominal distension and peripheral edema. With longer observation in uncontrolled long-term extension studies the safety profile was similar to that observed in the placebo controlled phase 3 trials.
&Copy; Adempas Patient Information is supplied by Cerner Multum, Inc. and Adempas Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
