"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
- Clinician Information:
Adempas Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Adempas (riociguat) is a soluble guanylate cyclase stimulator used to treat adults with two forms of pulmonary hypertension. Common side effects include headache, dizziness, indigestion, swelling of the legs and feet, nausea, diarrhea, and vomiting.
The recommended starting dosage of Adempas is 1 mg taken 3 times a day. Adempas may interact with nitrates, sildenafil, tadalafil, vardenafil, dipyridamole, theophylline, azole antifungals, HIV protease inhibitors, rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort, or antacids. Tell your doctor all medications and supplements you use. 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.
Our Adempas (riociguat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Adempas FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Bleeding [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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 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 events 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)
|Adverse Reactions||Adempas %
|Dyspepsia and Gastritis||21||8|
|Anemia (including laboratory parameters)||7||2|
|Gastroesophageal reflux disease||5||2|
Other events that were seen more frequently in riociguat compared to placebo and potentially related to treatment were: palpitations, nasal congestion, 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.
Read the entire FDA prescribing information for Adempas (Riociguat Tablets) »
Additional Adempas Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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