What the label lists and what reports show
Amlodipine and hydrochlorothiazide and valsartan side effects
Amlodipine and hydrochlorothiazide and valsartan's FDA label: “Most common adverse events (≥ 2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, and nasopharyngitis.” FAERS holds 3,689 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 (379 reports).
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and hydrochlorothiazide and valsartan FDA label on DailyMed (effective December 12, 2025, 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 HCT?EXFORGE HCT may cause serious side effects including: harm to an unborn baby causing injury or death. See “What is the most important information I should know about EXFORGE HCT?” low blood pressure (hypotension). Low blood pressure is most likely to happen if you: take water pills are on a low-salt diet have heart problems get dialysis treatments get sick with vomiting or diarrhea drink alcohol Lie down if you feel faint or dizzy. If you faint (lose consciousness), stop taking EXFORGE HCT. Call your doctor right away. 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. Some people will have changes in blood tests for kidney function and may need a lower dose of EXFORGE HCT. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 18d7820d-471f-4ee2-9ec6-25d8d27c77de), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse events (≥ 2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, and nasopharyngitis.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Preferred Term | Aml/Val/HCTZ 10/320/25 mg N=582 n (%) | Val/HCTZ 320/25 mg N=559 n (%) | Aml/Val 10/320 mg N=566 n (%) | HCTZ/Aml 25/10 mg N=561 n (%) |
|---|---|---|---|---|
| Dizziness | 48 (8.2) | 40 (7.2) | 14 (2.5) | 23 (4.1) |
| Edema | 38 (6.5) | 8 (1.4) | 65 (11.5 ) | 63 (11.2) |
| Headache | 30 (5.2) | 31 (5.5) | 30 (5.3) | 40 (7.1) |
| Dyspepsia | 13 (2.2) | 5 (0.9) | 6 (1.1) | 2 (0.4) |
| Fatigue | 13 (2.2) | 15 (2.7) | 12 (2.1) | 8 (1.4) |
| Muscle spasms | 13 (2.2) | 7 (1.3) | 7 (1.2) | 5 (0.9) |
| Back pain | 12 (2.1) | 13 (2.3) | 5 (0.9) | 12 (2.1) |
| Nausea | 12 (2.1) | 7 (1.3) | 10 (1.8) | 12 (2.1) |
| Nasopharyngitis | 12 (2.1) | 13 (2.3) | 13 (2.3) | 12 (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, continuedMost common adverse events (≥ 2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, and nasopharyngitis. ( 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 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 clinical practice. In the controlled trial of Exforge HCT, where only the maximum dose (10/320/25 mg) was evaluated, safety data were obtained in 582 patients with hypertension. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall frequency of adverse reactions was similar between men and women, younger (< 65 years) and older ( > 65 years) patients, and black and white patients. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 18d7820d-471f-4ee2-9ec6-25d8d27c77de), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,689 reports list amlodipine and hydrochlorothiazide and valsartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 505 are coded as a death and 1,014 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 19 reactions below, 5 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 hydrochlorothiazide 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