Riociguat Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 19, 2024.

Applies to riociguat: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects. Your blood pressure should be checked by your doctor every 2 weeks while taking this medicine.

Using this medicine while you are pregnant can cause very serious birth defects. Use a highly effective form of birth control or 2 forms of effective birth control to keep from getting pregnant while you are using this medicine and for at least 1 month after your last dose. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had a tubal ligation or has an IUD, she does not need to use a second form of birth control. If you think you have become pregnant while using this medicine, tell your doctor right away.

If you are a woman who can get pregnant, you must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment and for 1 month after treatment with this medicine. If you miss a period while you are using this medicine, tell your doctor right away.

Do not use this medicine together with a nitrate medicine (eg, nitroglycerin) or nitric oxide donor (eg, amyl nitrite). Do not use this medicine together with dipyridamole, theophylline, or medicine for impotence (eg, sildenafil, tadalafil, vardenafil). Using these medicines together may cause hypotension (low blood pressure).

This medicine could lower your blood pressure and cause you to feel dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel dizzy, lie or sit down so you do not faint.

Pulmonary edema (swelling in your lungs) may occur with this medicine. Check with your doctor right away if you have chest pain, difficult, fast, or noisy breathing, blue lips and fingernails, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, or shortness of breath.

Tell your doctor if you smoke before taking this medicine.

Do not take other medicines unless thy have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

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

See also:

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