What the label lists and what reports show
Amlodipine and valsartan side effects
Amlodipine and valsartan's FDA label: “The most common reasons for discontinuation of therapy with Exforge were peripheral edema and vertigo.” FAERS holds 11,192 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 blood pressure increased (664 reports).
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and valsartan FDA label on DailyMed (effective February 17, 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 EXFORGE?EXFORGE may cause serious side effects including: harm to an unborn baby causing injury and even death. See “What is the most important information I should know about EXFORGE?” low blood pressure (hypotension). Low blood pressure is most likely to happen if you: take water pills are on a low-salt diet get dialysis treatments have heart problems get sick with vomiting or diarrhea drink alcohol Lie down if you feel faint or dizzy. Call your doctor right away. more heart attacks and chest pain (angina) in people that already have severe heart problems. This may happen when you start EXFORGE or when there is an increase in your dose of EXFORGE. Get emergency help if you get worse chest pain or chest pain that does not go away. kidney problems. Kidney problems may become worse in people that already have kidney disease. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective February 17, 2026 (SPL set d0caec89-96ec-411d-a933-63eda74a6da7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common reasons for discontinuation of therapy with Exforge were peripheral edema and vertigo.
From the label: adverse reactions, continuedIn placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Exforge-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Exforge were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (≥ 2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness. ( 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Studies with Exforge: Exforge has been evaluated for safety in over 2600 patients with hypertension; over 1440 of these patients were treated for at least 6 months and over 540 of these patients were treated for at least 1 year. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective February 17, 2026 (SPL set d0caec89-96ec-411d-a933-63eda74a6da7), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,192 reports list amlodipine and valsartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,285 are coded as a death and 3,930 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, 3 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?
- Amlodipine 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