Drug Safety Information for LETAIRIS (Ambrisentan)

Safety-related Labeling Changes for LETAIRIS (AMBRISENTAN) Rx Drug: FDA Link

Adverse Drug Reactions for LETAIRIS* (Ambrisentan)

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 LETAIRIS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea7857
2Death4616
3Headache2675
4Pneumonia2482
5Dizziness2408
6Fluid retention2398
7Fatigue2158
8Oedema peripheral2153
9Oedema2078
10Unevaluable event1910
11Malaise1906
12Nasal congestion1726
13Cough1687
14Nausea1412
15Chest pain1221
16Diarrhoea1207
17Swelling1175
18Nasopharyngitis1144
19Syncope1141
20Local swelling1079

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

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

Reason # of FDA Reports
1Product used for unknown indication50479
2Pulmonary arterial hypertension28297
3Pulmonary hypertension13041
4Cor pulmonale chronic2425
5Scleroderma2162
6Portopulmonary hypertension570
7Systemic lupus erythematosus525
8Systemic sclerosis491
9Sleep apnoea syndrome483
10Pulmonary fibrosis446

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


Types of Adverse Events for LETAIRIS

Total Reports Filed with FDA: 112903


Number of FDA Adverse Event Reports by Patient Age for LETAIRIS

Total Reports Filed with FDA: 112903*


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

Charts are based on 112903 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 LETAIRIS 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.