Riociguat Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 23, 2024.

Applies to riociguat: oral tablet.

Important warnings This medicine can cause some serious health issues

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 riociguat

Along with its needed effects, riociguat 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 side effects

• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• nosebleeds
• unusual tiredness or weakness

Less common side effects

• 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 riociguat

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 side effects

• diarrhea
• headache
• heartburn
• indigestion
• nausea
• stuffy nose
• vomiting

Less common side effects

• difficulty having a bowel movement

For healthcare professionals

Applies to riociguat: oral tablet.

General adverse events

Adverse reactions occurring in 10% of patients or greater included headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, gastritis, dyspepsia, vomiting, peripheral edema, cough, nasopharyngitis, decreased hemoglobin, and decreased hematocrit.^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (up to 10%)

Gastrointestinal

• Very common (10% or more): Gastritis (up to 21%), dyspepsia (up to 21%), nausea (up to 14%), diarrhea (up to 12%), vomiting (up to 10%)
• Common (1% to 10%): Gastroesophageal reflux disease, constipation, gastrointestinal/abdominal pain, gastritis, dysphagia, abdominal distension, hematemesis

Hematologic

• Very common (10% or more): Decreased hemoglobin (up to 24.1%), decreased hematocrit (up to 13.3%)
• Common (1% to 10%): Anemia, serious bleeding, serious hemoptysis
• Frequency not reported: Serious hemorrhagic events (vaginal, catheter-site, intra-abdominal, pulmonary)

Nervous system

• Very common (10% or more): Headache (up to 27%), dizziness (up to 20%)
• Frequency not reported: Subdural hematoma

Other

• Very common (10% or more): Peripheral edema (up to 13.7%)
• Common (1% to 10%): Chest pain/discomfort, fatigue, pain in extremity

Respiratory

• Very common (10% or more): Cough (up to 13.6%), nasopharyngitis (up to 11.8%)
• Common (1% to 10%): Dyspnea, epistaxis, nasal congestion
• Uncommon (0.1% to 1%): Hemoptysis

Further information

Riociguat side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer