What the label lists and what reports show
Riociguat side effects
Riociguat's FDA label lists its adverse reactions in its own words. FAERS holds 32,415 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (5,718 reports).
- Generic listed
- Boxed warning
Check it at the source: the riociguat FDA label on DailyMed (effective August 13, 2026, Bayer HealthCare Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Adempas?Adempas can cause serious side effects including: • Serious birth defects. (See "What is the most important information I should know about Adempas?") • Reduced blood pressure. Adempas reduces blood pressure. This may cause symptoms of low blood pressure, such as lightheadedness, chest pain, and dizziness especially in people who are dehydrated, or have a severe blockage of blood flow out of the heart, or have certain other medical problems. Your doctor will check you for these problems. • Increased risk of bleeding, including bleeding from the respiratory tract. Tell your doctor right away if you cough up blood during treatment with Adempas. • Worsening of symptoms in people with Pulmonary Veno-Occlusive Disease (PVOD). If you have PVOD, treatment with Adempas may cause a build-up of fluid in your lungs (pulmonary edema). This may cause you to feel short of breath. […]
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026 (SPL set 7b57509a-3d5d-41d4-8fed-1471e26372a3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are discussed elsewhere in the labeling: • Embryo-Fetal Toxicity [see Warnings and Precautions (5.1) ] • Hypotension [see Warnings and Precautions (5.2) ] • Bleeding [see Warnings and Precautions (5.3) ] Adverse reactions occurring more frequently (≥3%) on Adempas compared to placebo are headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Table 1: Adverse Reactions Occurring More Frequently (≥3%) on Adempas than Placebo (Pooled from CHEST-1 and PATENT-1)
| Adverse Reactions | Adempas % (n=490) | Placebo % (n=214) |
|---|---|---|
| Headache | 27 | 18 |
| Dyspepsia and Gastritis | 21 | 8 |
| Dizziness | 20 | 13 |
| Nausea | 14 | 11 |
| Diarrhea | 12 | 8 |
| Hypotension | 10 | 4 |
| Vomiting | 10 | 7 |
| Anemia (including laboratory parameters) | 7 | 2 |
| Gastroesophageal reflux disease | 5 | 2 |
| Constipation | 5 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026 (SPL set 7b57509a-3d5d-41d4-8fed-1471e26372a3), via openFDA; the full label on DailyMed
What do FAERS reports show?
32,415 reports list riociguat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,092 are coded as a death and 15,294 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Riociguat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions