Drug Safety Information for REMODULIN (Treprostinil sodium)

Safety-related Labeling Changes for REMODULIN (TREPROSTINIL SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for TYVASO (TREPROSTINIL SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for REMODULIN* (Treprostinil sodium)

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 REMODULIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death3800
2Dyspnoea2805
3Headache1568
4Cough1334
5Nausea1186
6Diarrhoea1084
7Dizziness1071
8Pneumonia1023
9Pulmonary arterial hypertension955
10Fatigue937
11Fluid retention824
12Drug dose omission800
13Malaise787
14Hypotension709
15Vomiting681
16Chest pain672
17Device related infection636
18Infusion site pain601
19Syncope582
20Oedema peripheral573

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

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

Reason # of FDA Reports
1Pulmonary arterial hypertension19649
2Cor pulmonale chronic7357
3Pulmonary hypertension5930
4Product used for unknown indication4396
5Systemic sclerosis91
6Portopulmonary hypertension70
7Hypertension48
8Cor pulmonale40
9Atrial septal defect40
10Scleroderma33

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


Types of Adverse Events for REMODULIN

Total Reports Filed with FDA: 63200


Number of FDA Adverse Event Reports by Patient Age for REMODULIN

Total Reports Filed with FDA: 63200*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Treprostinil sodium (Ut-15, Treprostinil sodium, Remodulin, Treprostinil, Tyvaso)

Charts are based on 63200 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 REMODULIN 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.