Note: This document contains side effect information about riociguat. Some dosage forms listed on this page may not apply to the brand name Adempas.
Summary
Common side effects of Adempas include: dyspepsia, gastritis, and headache. Continue reading for a comprehensive list of adverse effects.
Applies to riociguat: oral tablet.
Warning
Oral route (Tablet)
Do not administer riociguat to a pregnant female because it may cause fetal harm. Females of reproductive potential: Exclude pregnancy before start of treatment, monthly during treatment, and 1 month after treatment discontinuation. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. For all females, riociguat is available only through a restricted program called the Adempas REMS Program.
Serious side effects of Adempas
Along with its needed effects, riociguat (the active ingredient contained in Adempas) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking riociguat:
More common
- Confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- nosebleeds
- unusual tiredness or weakness
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or black, tarry stools
- bruising or purple areas on the skin
- coughing or spitting up blood
- decreased alertness
- fast, irregular, pounding, or racing heartbeat or pulse
- heavy non-menstrual vaginal bleeding
- rapid weight gain
- stomach pain or swelling
- troubled breathing with exertion
- vomiting of blood or material that looks like coffee grounds
Other side effects of Adempas
Some side effects of riociguat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- headache
- heartburn
- indigestion
- nausea
- stuffy nose
- vomiting
Less common
- Difficulty having a bowel movement
For Healthcare Professionals
Applies to riociguat: oral tablet.
General
The most frequently reported side effects were headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux, and constipation.[Ref]
Cardiovascular
Very common (10% or more): Peripheral edema (up to 17.3%), hypotension (up to 10%)
Common (1% to 10%): Palpitation, chest pain, chest discomfort[Ref]
Nervous system
Very common (10% or more): Headache (up to 27%), dizziness (up to 20%)[Ref]
Gastrointestinal
Very common (10% or more): Dyspepsia (up to 21%), gastritis (21%), nausea (up to 14.1%), diarrhea (up to 12%), vomiting (up to 10.2%)
Common (1% to 10%): Gastroesophageal reflux disease, constipation, gastroenteritis, gastrointestinal/abdominal pain, dysphagia, abdominal distention[Ref]
Hematologic
Very common (10% or more): Hemoglobin decreased (24.1%), hematocrit decreased (13.3%)
Common (1% to 10%): Anemia[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (11.8%)
Common (1% to 10%): Dyspnea, cough, nasal congestion, epistaxis, hemoptysis
Frequency not reported: Pulmonary hemorrhage[Ref]
Musculoskeletal
Common (1% to 10%): Pain in extremity[Ref]
Other
Common (1% to 10%): Fatigue[Ref]
