What the label lists and what reports show
Ambrisentan side effects
Ambrisentan's FDA label: “Most common adverse reactions (>3% compared to placebo) are peripheral edema, nasal congestion, sinusitis, and flushing ( 6.1 ).” FAERS holds 124,133 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 (19,143 reports).
- Generic listed
- Boxed warning
Check it at the source: the ambrisentan FDA label on DailyMed (effective September 3, 2026, Apotex Corp.); 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 ambrisentan tablets?Ambrisentan tablets can cause serious side effects including: See "What is the most important information I should know about ambrisentan tablets ?" Swelling all over the body (fluid retention) can happen within weeks after starting ambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital. Decreased sperm count. Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you. Low red blood cell levels (anemia) can happen during the first weeks after starting ambrisentan tablets. […]
Source: FDA drug label, Apotex Corp., effective September 3, 2026 (SPL set 291a782a-77e1-8a8e-e1c8-2626f305c2b7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>3% compared to placebo) are peripheral edema, nasal congestion, sinusitis, and flushing ( 6.1 ).
Table 2 Adverse Reactions Reported More Commonly (>5%) on Letairis + Tadalafil than on Letairis or Tadalafil Monotherapy (ITT) in AMBITION
This table is printed in the Letairis label published by Gilead Sciences, Inc. of June 22, 2026; the label quoted above does not print one.
| Adverse Reactions | Letairis + Tadalafil Combination Therapy (N=302) n (%) | Letairis Monotherapy (N=152) n (%) | Tadalafil Monotherapy (N=151) n (%) |
|---|---|---|---|
| Peripheral edema | 135 (45%) | 58 (38%) | 43 (28%) |
| Headache | 125 (41%) | 51 (34%) | 53 (35%) |
| Nasal congestion | 58 (19%) | 25 (16%) | 17 (11%) |
| Cough | 53 (18%) | 20 (13%) | 24 (16%) |
| Anemia | 44 (15%) | 11 (7%) | 17 (11%) |
| Dyspepsia | 32 (11%) | 5 (3%) | 18 (12%) |
| Bronchitis | 31 (10%) | 6 (4%) | 13 (9%) |
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.
From the label: adverse reactions, continuedClinically significant adverse reactions that appear in other sections of the labeling include: Embryo-fetal Toxicity [see Warnings and Precautions (5.1), Use in Specific Populations (8.1) ] Fluid Retention [see Warnings and Precautions (5.2) ] Pulmonary Edema with PVOD [see Warnings and Precautions (5.3) ] Decreased Sperm Count [see Warnings and Precautions (5.4) ] Hematologic Changes [see Warnings and Precautions (5.5) ] Most common adverse reactions (>3% compared to placebo) are peripheral edema, nasal congestion, sinusitis, and flushing ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data for ambrisentan tablets are presented from two 12-week, placebo-controlled studies (ARIES-1 and ARIES-2) in patients with pulmonary arterial hypertension (PAH). The exposure to ambrisentan in these studies ranged from 6 days to 100 days. In ARIES-1 and ARIES-2, a total of 261 patients received ambrisentan tablets at doses of 2.5 mg, 5 mg, or 10 mg once daily and 132 patients received placebo. …
Source: FDA drug label, Apotex Corp., effective September 3, 2026 (SPL set 291a782a-77e1-8a8e-e1c8-2626f305c2b7), via openFDA; the full label on DailyMed
What do FAERS reports show?
124,133 reports list ambrisentan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17,005 are coded as a death and 52,456 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?
- Ambrisentan: 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