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Adempas Side Effects

Generic name: riociguat

Medically reviewed by Drugs.com. Last updated on May 17, 2023.

Note: This document contains side effect information about riociguat. Some dosage forms listed on this page may not apply to the brand name Adempas.

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

Less common

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

Less common

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. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Adempas (riociguat). Bayer Pharmaceutical Inc. 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.