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Riociguat Side Effects

In Summary

Commonly reported side effects of riociguat include: dyspepsia, gastritis, and headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to riociguat: oral tablet

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
  • Confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • nosebleeds
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain or swelling
  • 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
  • troubled breathing with exertion
  • vomiting of blood or material that looks like coffee grounds

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 or indigestion
  • nausea or vomiting
  • stuffy nose
Less common
  • Difficulty having a bowel movement (stool)

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Adempas (riociguat)." Bayer Pharmaceutical Inc, West Haven, CT.

Some side effects of riociguat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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