Drug Safety Information for OPSUMIT (Macitentan)

REMS for Opsumit (MACITENTAN) Rx Drug: Safety Information Link

FDA Risk Evaluation and Mitigation Strategy REMS

FDA Safety-related Labeling Changes for OPSUMIT (MACITENTAN) Rx Drug: Safety Information Link

Fluid overload Safety label updated

Adverse Drug Reactions for OPSUMIT* (Macitentan)

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 OPSUMIT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dyspnoea	605
2	Death	468
3	Pneumonia	310
4	Headache	276
5	Pulmonary arterial hypertension	230
6	Fluid retention	202
7	Nausea	198
8	Fatigue	197
9	Oedema peripheral	186
10	Diarrhoea	173
11	Cough	167
12	Malaise	166
13	Dizziness	155
14	Hypotension	150
15	Oedema	141
16	Condition aggravated	138
17	Chest pain	128
18	Anaemia	115
19	Disease progression	107
20	Asthenia	105

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

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

	Reason	# of FDA Reports
1	Pulmonary arterial hypertension	7278
2	Product used for unknown indication	2440
3	Pulmonary hypertension	1353
4	Cor pulmonale chronic	630
5	Connective tissue disorder	88
6	Portopulmonary hypertension	82
7	Portal hypertension	21
8	Eisenmenger's syndrome	17
9	Cardiac disorder	13
10	Glioblastoma	12

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

Types of Adverse Events for OPSUMIT

Total Reports Filed with FDA: 12617

Number of FDA Adverse Event Reports by Patient Age for OPSUMIT

Total Reports Filed with FDA: 12617*

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

Charts are based on 12617 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.

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.