What the label lists and what reports show
Sacubitril and valsartan side effects
Sacubitril and valsartan's FDA label lists its adverse reactions in its own words. FAERS holds 115,389 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 hypotension (11,577 reports).
- Generic listed
- Boxed warning
Check it at the source: the sacubitril and valsartan FDA label on DailyMed (effective July 6, 2026, Novartis Pharmaceuticals Corporation); 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 ENTRESTO or ENTRESTO SPRINKLE?ENTRESTO or ENTRESTO SPRINKLE may cause serious side effects, including: See “What is the most important information I should know about ENTRESTO or ENTRESTO SPRINKLE?” Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take ENTRESTO or ENTRESTO SPRINKLE again if you have had angioedema during treatment with ENTRESTO or ENTRESTO SPRINKLE. People who are Black and take ENTRESTO or ENTRESTO SPRINKLE may have a higher risk of having angioedema than people who are not Black and take ENTRESTO or ENTRESTO SPRINKLE. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 6, 2026 (SPL set 000dc81d-ab91-450c-8eae-8eb74e72296f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsClinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions (5.2)] Hypotension [see Warnings and Precautions (5.3)] Impaired Renal Function [see Warnings and Precautions (5.4)] Hyperkalemia [see Warnings and Precautions (5.5)] Adverse reactions occurring greater than or equal to 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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. …
Table 3: Adverse Reactions Reported in greater than or equal to 5% of Patients Treated with ENTRESTO in the Double-Blind Period of PARADIGM-HF
| Reaction | ENTRESTO (n = 4,203) % | Enalapril (n = 4,229) % |
|---|---|---|
| Hypotension | 18 | 12 |
| Hyperkalemia | 12 | 14 |
| Cough | 9 | 13 |
| Dizziness | 6 | 5 |
| Renal failure/acute renal failure | 5 | 5 |
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.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 6, 2026 (SPL set 000dc81d-ab91-450c-8eae-8eb74e72296f), via openFDA; the full label on DailyMed
What do FAERS reports show?
115,389 reports list sacubitril and valsartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,147 are coded as a death and 20,918 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 20 reactions below, 4 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?
- Sacubitril and valsartan: 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