What the label lists and what reports show
Valsartan side effects
Valsartan's FDA label: “Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) …” FAERS holds 104,490 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 fatigue (5,634 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the valsartan FDA label on DailyMed (effective August 5, 2026, Macleods Pharmaceuticals Limited); 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 valsartan tablets?Valsartan tablets can cause serious side effects, including: See “What is the most important information I should know about valsartan tablets?” • Low blood pressure (hypotension). Low blood pressure can happen with valsartan tablets, especially when you first start taking it and can cause you to feel lightheaded. Feeling lightheaded is most likely to happen if you: o take water pills o are dehydrated (decreased body fluids) due to vomiting and diarrhea o are on a low-salt diet o you sweat excessively o get dialysis treatments o have heart problems o do not drink enough liquids Lie down, if you feel lightheaded, dizzy or faint. Call your healthcare provider right away. • Kidney problems. Kidney problems may get worse in people that already have kidney disease or heart problems. Your doctor may do blood tests to check for this. • Increased potassium in your blood. […]
Source: FDA drug label, Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Valsartan (n=3,282) | Placebo (n=2,740) |
|---|---|---|
| Dizziness | 17% | 9% |
| Hypotension | 7% | 2% |
| Diarrhea | 5% | 4% |
| Arthralgia | 3% | 2% |
| Fatigue | 3% | 2% |
| Back Pain | 3% | 2% |
| Dizziness, postural | 2% | 1% |
| Hyperkalemia | 2% | 1% |
| Hypotension, postural | 2% | 1% |
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, continuedHypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with valsartan was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. …
Source: FDA drug label, Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46), via openFDA; the full label on DailyMed
What do FAERS reports show?
104,490 reports list valsartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,543 are coded as a death and 39,227 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 21 reactions below, 10 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?
- 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