Drug Safety Information for ADEMPAS (Riociguat)

REMS for Adempas (RIOCIGUAT) Rx Drug: FDA Link

FDA Risk Evaluation and Mitigation Strategy REMS

Safety-related Labeling Changes for ADEMPAS (RIOCIGUAT) Rx Drug: FDA Link

Adverse Drug Reactions for ADEMPAS* (Riociguat)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ADEMPAS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea298
2Headache184
3Nausea180
4Diarrhoea176
5Hypotension172
6Dizziness171
7Fatigue160
8Oedema peripheral146
9Vomiting101
10Oedema95
11Fluid retention89
12Pulmonary arterial hypertension84
13Pneumonia81
14Cough81
15Malaise81
16Asthenia69
17Syncope64
18Death64
19Dyspepsia54
20Abdominal distension51

* This side effect also appears in "Top 10 Side Effects of ADEMPAS " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ADEMPAS
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication1924
2Pulmonary arterial hypertension1043
3Pulmonary hypertension563
4Cor pulmonale chronic104
5Pulmonary infarction15
6Pulmonary haemosiderosis15
7Left ventricular dysfunction12
8Oedema10
9Idiopathic pulmonary fibrosis9
10Cardiac disorder4

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ADEMPAS

Total Reports Filed with FDA: 6240


Number of FDA Adverse Event Reports by Patient Age for ADEMPAS

Total Reports Filed with FDA: 6240*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Riociguat (Adempas)

Charts are based on 6240 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ADEMPAS Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.