Dafiro HCT (Amlodipine / Valsartan / Hydrochlorothiazide)
Triple combination antihypertensive for blood pressure control
Dafiro HCT is a prescription medicine that combines three active substances – amlodipine, valsartan, and hydrochlorothiazide – in a single tablet to treat high blood pressure (hypertension) in adults. It is typically prescribed when blood pressure is not adequately controlled by two-component therapy. By acting through three complementary mechanisms, Dafiro HCT provides more effective blood pressure reduction and helps protect against cardiovascular complications such as stroke and heart attack.
Quick Facts
Key Takeaways
- Dafiro HCT combines three blood pressure-lowering agents (amlodipine, valsartan, and hydrochlorothiazide) in one tablet for simplified once-daily dosing.
- It is intended for patients whose blood pressure is not adequately controlled by dual-component therapy, not as a first-line treatment.
- Dafiro HCT must not be used during pregnancy as valsartan can cause serious harm to the unborn baby.
- Regular monitoring of kidney function, electrolytes (especially potassium and sodium), and blood pressure is essential during treatment.
- Common side effects include dizziness, headache, and peripheral edema (swollen ankles), which usually improve over time.
What Is Dafiro HCT and What Is It Used For?
Quick Answer: Dafiro HCT is a triple-combination prescription medicine containing amlodipine, valsartan, and hydrochlorothiazide. It is used to treat high blood pressure (hypertension) in adults when two-component therapy alone does not provide sufficient blood pressure control.
Dafiro HCT belongs to a class of medicines known as fixed-dose combination antihypertensives. Each tablet contains three active substances that lower blood pressure through distinct and complementary mechanisms. Amlodipine is a calcium channel blocker (CCB) that relaxes and widens blood vessels by preventing calcium from entering the smooth muscle cells in artery walls. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the action of angiotensin II, a hormone that causes blood vessels to constrict and promotes salt and water retention. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that increases urine production, reducing the volume of fluid in the bloodstream.
By combining these three mechanisms in a single tablet, Dafiro HCT achieves greater blood pressure reduction than any one or two of its components used alone. Clinical trials have demonstrated that the triple combination produces statistically significant additional blood pressure lowering compared to the corresponding two-component combinations. This additive effect is particularly valuable for patients with moderate-to-severe hypertension or those who have not achieved target blood pressure with simpler regimens.
High blood pressure is a major risk factor for cardiovascular disease, including stroke, heart attack, heart failure, and kidney disease. The World Health Organization estimates that hypertension affects approximately 1.28 billion adults worldwide, yet only about one in five people with hypertension have their condition under control. For many patients, achieving target blood pressure requires more than one antihypertensive agent. The European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) 2023 guidelines recommend initial treatment with a two-drug combination, escalating to triple therapy when needed. Dafiro HCT addresses this clinical need by offering a convenient single-pill triple combination.
The medicine is marketed under the brand names Dafiro HCT and Exforge HCT in different countries. It is manufactured by Novartis and was first approved by the European Medicines Agency (EMA) in 2009. Dafiro HCT is available in several strength combinations to allow dose adjustment based on individual patient needs: 5/160/12.5 mg, 5/160/25 mg, 10/160/12.5 mg, 10/160/25 mg, and 10/320/25 mg (amlodipine/valsartan/hydrochlorothiazide).
What Should You Know Before Taking Dafiro HCT?
Quick Answer: Dafiro HCT is contraindicated in pregnancy, severe liver or kidney disease, and in patients with certain electrolyte disorders. Inform your doctor about all medical conditions and medications before starting treatment.
Contraindications
You must not take Dafiro HCT if any of the following apply to you:
- Allergy to amlodipine, valsartan, hydrochlorothiazide, other sulfonamide-derived substances, other dihydropyridine calcium channel blockers, or any of the other ingredients in the tablet.
- Pregnancy or planning to become pregnant. Dafiro HCT can cause serious injury or death to the developing baby, particularly during the second and third trimesters.
- Severe liver disease, including biliary cirrhosis or cholestasis (impaired bile flow).
- Severe kidney disease (glomerular filtration rate below 30 mL/min) or anuria (absence of urine production).
- Refractory hypokalemia (persistently low potassium), hyponatremia (low sodium), hypercalcemia (high calcium), or symptomatic hyperuricemia (gout).
- Concomitant use with aliskiren in patients with diabetes mellitus or moderate-to-severe renal impairment.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Dafiro HCT if you have or have had any of the following conditions:
- Kidney problems: Hydrochlorothiazide and valsartan can affect kidney function. Your doctor will monitor your kidney function through regular blood tests, particularly during the first weeks of treatment.
- Liver disease: Amlodipine is primarily metabolized by the liver, and dose adjustment may be necessary. Patients with mild-to-moderate hepatic impairment should be started on the lowest available dose.
- Heart failure or aortic/mitral valve stenosis: Extra caution is needed as blood pressure-lowering medicines can worsen these conditions.
- Diabetes mellitus: Hydrochlorothiazide can increase blood glucose levels, and dose adjustments of diabetic medication may be needed.
- Gout: Hydrochlorothiazide can increase uric acid levels and may trigger gout attacks.
- Systemic lupus erythematosus (SLE): Hydrochlorothiazide has been associated with activation or exacerbation of SLE.
- Electrolyte imbalances: Regular monitoring of sodium, potassium, calcium, and magnesium levels is essential, especially in patients also taking potassium supplements or potassium-sparing diuretics.
- Photosensitivity: Hydrochlorothiazide can increase sensitivity to sunlight. Use sunscreen and protective clothing, particularly during the first weeks of treatment. Cases of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) have been observed with cumulative increasing doses of hydrochlorothiazide.
Stop taking Dafiro HCT and seek immediate medical attention if you experience symptoms of angioedema: swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing. Angioedema is a rare but potentially life-threatening adverse reaction associated with valsartan.
Pregnancy and Breastfeeding
Pregnancy: Dafiro HCT must not be used during pregnancy. The valsartan component belongs to a class of medicines (angiotensin II receptor blockers) known to cause serious fetal harm when used during the second and third trimesters, including reduced amniotic fluid (oligohydramnios), fetal kidney failure, skull bone underdevelopment, and fetal death. If you become pregnant while taking Dafiro HCT, stop the medicine immediately and contact your doctor. Women of childbearing potential should use reliable contraception during treatment.
Breastfeeding: Dafiro HCT is not recommended during breastfeeding. Amlodipine and hydrochlorothiazide are excreted into human breast milk. It is not known whether valsartan passes into breast milk. Due to the potential for serious adverse effects in the nursing infant, a decision must be made whether to discontinue breastfeeding or discontinue the medicine, taking into account the importance of treatment to the mother. Consult your doctor for guidance on alternative antihypertensive options that are compatible with breastfeeding.
How Does Dafiro HCT Interact with Other Drugs?
Quick Answer: Dafiro HCT can interact with many medications including lithium, NSAIDs, other blood pressure medicines, potassium supplements, and certain heart medicines. Always inform your doctor about all medications you are taking.
Drug interactions can alter how Dafiro HCT works or increase the risk of serious side effects. The three active substances in Dafiro HCT each have their own interaction profile, making it particularly important to review all concomitant medications. Below is a summary of the most clinically significant interactions.
Major Interactions
| Interacting Drug | Component Affected | Effect | Recommendation |
|---|---|---|---|
| Lithium | HCTZ + Valsartan | Increased lithium levels, risk of toxicity | Avoid combination; if used, monitor lithium levels closely |
| ACE inhibitors (e.g. enalapril, ramipril) | Valsartan | Dual RAAS blockade: increased risk of hypotension, hyperkalemia, renal impairment | Avoid combination; contraindicated in diabetic patients |
| Aliskiren | Valsartan | Dual RAAS blockade: increased risk of hypotension, hyperkalemia, renal failure | Contraindicated in patients with diabetes or renal impairment |
| Potassium supplements / potassium-sparing diuretics | Valsartan + HCTZ | Risk of hyperkalemia or unpredictable potassium levels | Monitor potassium levels frequently; adjust doses as needed |
| NSAIDs (e.g. ibuprofen, naproxen) | Valsartan + HCTZ | Reduced antihypertensive effect; increased risk of renal impairment | Use with caution; monitor renal function and blood pressure |
Other Notable Interactions
| Interacting Drug | Component Affected | Effect | Recommendation |
|---|---|---|---|
| Simvastatin | Amlodipine | Increased simvastatin levels; higher risk of myopathy/rhabdomyolysis | Limit simvastatin to 20 mg/day when used with amlodipine |
| Ciclosporin | Amlodipine | Increased ciclosporin levels | Monitor ciclosporin levels and adjust dose |
| Digoxin | HCTZ | Hypokalemia from HCTZ increases risk of digoxin toxicity | Monitor potassium levels and ECG |
| Antidiabetic agents (insulin, metformin) | HCTZ | HCTZ may increase blood glucose; dose adjustment of antidiabetics may be required | Monitor blood glucose more frequently |
| Alcohol | All three | Enhanced blood pressure-lowering effect; increased risk of dizziness and orthostatic hypotension | Limit alcohol intake |
| CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) | Amlodipine | Increased amlodipine plasma levels | Monitor for signs of excessive blood pressure lowering |
Always inform your doctor or pharmacist about all medicines you are taking, including prescription and over-the-counter drugs, vitamins, and herbal supplements. This list is not exhaustive – other interactions may exist. Your pharmacist can check for interactions when you fill your prescription.
What Is the Correct Dosage of Dafiro HCT?
Quick Answer: The usual dose is one tablet taken orally once daily, with or without food. The specific strength is determined by your doctor based on your blood pressure response and tolerance. Dafiro HCT is not intended for initial therapy.
Dafiro HCT is intended for patients who are already stabilized on the individual components (amlodipine, valsartan, and hydrochlorothiazide) given separately or as dual combinations, or for those whose blood pressure is not adequately controlled on a two-drug combination. The dose is individualized based on the patient's current therapy, clinical response, and tolerability.
Adults
Recommended Adult Dosage
One film-coated tablet taken once daily, preferably at the same time each day. Tablets should be swallowed whole with water and can be taken with or without food. The available strength combinations are:
- 5/160/12.5 mg – Starting dose for patients transitioning from dual therapy
- 5/160/25 mg – For patients requiring higher diuretic dose
- 10/160/12.5 mg – For patients requiring higher amlodipine dose
- 10/160/25 mg – Higher combination dose
- 10/320/25 mg – Maximum recommended dose
The maximum recommended daily dose is amlodipine 10 mg / valsartan 320 mg / hydrochlorothiazide 25 mg. Dose adjustment should be made at intervals of at least 2 weeks to allow the full blood pressure-lowering effect to develop.
Children and Adolescents
Pediatric Use
Dafiro HCT is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of this triple combination have not been established in this age group. Pediatric hypertension should be managed with individually dosed single-agent or two-drug combinations under specialist supervision.
Elderly Patients
Dosing in the Elderly
Caution is required when prescribing Dafiro HCT to elderly patients, especially those over 75 years of age. The starting dose should generally be the lowest available strength (5/160/12.5 mg). Elderly patients are more susceptible to orthostatic hypotension (dizziness upon standing), electrolyte disturbances, and renal impairment. Amlodipine clearance is reduced in elderly patients, and dose titration should proceed slowly. Regular monitoring of kidney function, electrolytes, and blood pressure is essential.
Missed Dose
If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next scheduled dose, skip the missed dose and take the next one at the regular time. Do not take a double dose to make up for a forgotten tablet. Setting a daily reminder can help ensure consistent dosing and optimal blood pressure control.
Overdose
If you take more Dafiro HCT than prescribed, seek immediate medical attention or contact your local poison control center. Overdose symptoms may include severe dizziness, fainting, rapid or irregular heartbeat, excessive drop in blood pressure, dehydration, and electrolyte imbalances. Treatment is supportive: for amlodipine overdose, activated charcoal (if given within 1–2 hours) and intravenous calcium gluconate may be used. Valsartan is not effectively removed by hemodialysis. Hydrochlorothiazide overdose may cause severe electrolyte depletion requiring intravenous fluid and electrolyte replacement.
What Are the Side Effects of Dafiro HCT?
Quick Answer: The most common side effects include dizziness, headache, peripheral edema (swollen ankles), and low potassium levels. Serious but rare side effects include angioedema, severe hypotension, and acute kidney injury. Most side effects are mild and improve with continued use.
Like all medicines, Dafiro HCT can cause side effects, although not everybody gets them. The side effects listed below reflect the combined safety profile of all three active substances. The frequency categories are based on clinical trial data and post-marketing surveillance reports from the EMA and FDA.
Very Common (may affect more than 1 in 10 people)
- Hypokalemia (low potassium levels in the blood)
Common (may affect up to 1 in 10 people)
- Dizziness, especially when standing up (orthostatic dizziness)
- Headache
- Peripheral edema (swelling of ankles and feet)
- Fatigue and asthenia (weakness)
- Flushing (feeling of warmth in the face)
- Nasopharyngitis (inflammation of the nose and throat)
- Increased blood uric acid levels
- Increased blood creatinine (reduced kidney function)
- Muscle spasms and cramps
- Nausea
- Pollakiuria (frequent urination)
Uncommon (may affect up to 1 in 100 people)
- Hypotension (excessively low blood pressure)
- Paresthesia (tingling or numbness)
- Vertigo (spinning sensation)
- Tachycardia (rapid heartbeat) or palpitations
- Dry mouth
- Abdominal pain, constipation, or diarrhea
- Joint pain (arthralgia)
- Back pain
- Erectile dysfunction
- Visual disturbances
- Hyponatremia (low sodium levels)
- Photosensitivity reaction (skin rash from sunlight)
Rare (may affect up to 1 in 1,000 people)
- Angioedema (swelling of face, lips, tongue, throat)
- Hepatitis (inflammation of the liver)
- Acute kidney injury
- Interstitial nephritis
- Thrombocytopenia (low platelet count)
- Aplastic anemia
- Pancreatitis (inflammation of the pancreas)
- Stevens-Johnson syndrome (severe skin reaction)
- Acute angle-closure glaucoma
- Acute myopia (sudden change in vision)
Contact your doctor or seek emergency medical care immediately if you experience: swelling of the face, lips, tongue, or throat (angioedema); severe skin blistering or peeling; chest pain or irregular heartbeat; signs of severe allergic reaction (difficulty breathing, rash, fever); yellowing of skin or eyes (jaundice); or significantly reduced urine output. These reactions are rare but can be serious.
If you experience any side effects, even those not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority (e.g., the FDA MedWatch program in the United States, or the Yellow Card Scheme in the United Kingdom) to help provide more information on the safety of this medicine.
How Should You Store Dafiro HCT?
Quick Answer: Store Dafiro HCT below 30°C (86°F) in the original packaging to protect from moisture. Keep out of the sight and reach of children.
Proper storage of Dafiro HCT is essential to maintain its effectiveness and safety. Follow these storage guidelines:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze.
- Moisture protection: Store in the original blister packaging to protect from moisture. Hydrochlorothiazide is particularly sensitive to humidity.
- Light protection: Keep the tablets in their original packaging to protect from light.
- Keep away from children: Store the medicine in a place where children cannot see or reach it.
- Expiry date: Do not use Dafiro HCT after the expiry date printed on the carton and blister pack. The expiry date refers to the last day of that month.
- Disposal: Do not throw unused medicines in the wastewater or household waste. Ask your pharmacist about how to properly dispose of medicines you no longer use. These measures help protect the environment.
If you notice that the tablets have changed color, become crumbly, or have an unusual appearance, do not take them. Contact your pharmacist for a replacement.
What Does Dafiro HCT Contain?
Quick Answer: Each Dafiro HCT tablet contains three active substances – amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide – plus inactive excipients including microcrystalline cellulose, crospovidone, and magnesium stearate.
Active Substances
The active substances and their roles are:
- Amlodipine (as amlodipine besylate) – A dihydropyridine calcium channel blocker. Available in 5 mg or 10 mg strength per tablet. Amlodipine works by relaxing and widening blood vessels, allowing blood to flow more easily and reducing the workload on the heart. Its long half-life (30–50 hours) supports consistent 24-hour blood pressure control with once-daily dosing.
- Valsartan – An angiotensin II receptor blocker (ARB). Available in 160 mg or 320 mg strength per tablet. Valsartan selectively blocks the AT1 receptor, preventing angiotensin II from causing vasoconstriction and aldosterone release. This leads to vasodilation and reduced sodium and water retention.
- Hydrochlorothiazide (HCTZ) – A thiazide diuretic. Available in 12.5 mg or 25 mg strength per tablet. HCTZ acts on the distal convoluted tubule in the kidneys to inhibit sodium and chloride reabsorption, promoting water excretion and reducing blood volume. It also has a mild vasodilatory effect with chronic use.
Inactive Ingredients (Excipients)
The inactive ingredients help give the tablet its form, stability, and coating. They include:
- Tablet core: Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate
- Film coating: Hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide yellow (E172). Depending on the strength, additional colorants such as iron oxide red (E172) may be present
If you are allergic to any of the inactive ingredients listed above, inform your doctor or pharmacist before taking Dafiro HCT. Patients with known sulfonamide allergy should exercise caution, as hydrochlorothiazide is a sulfonamide-derived substance and cross-reactivity may occur in rare cases.
Frequently Asked Questions About Dafiro HCT
Dafiro HCT is used to treat high blood pressure (hypertension) in adults. It contains three active substances – amlodipine, valsartan, and hydrochlorothiazide – that work together through complementary mechanisms to lower blood pressure more effectively than single or dual therapy. It is prescribed for patients whose blood pressure is not adequately controlled by two-component treatment.
No. Dafiro HCT must not be used during pregnancy, as the valsartan component can cause serious injury or death to the developing baby, particularly during the second and third trimesters. If you become pregnant, stop the medicine immediately and contact your doctor. Women of childbearing potential should use reliable contraception.
The most common side effects include low potassium levels (hypokalemia), dizziness, headache, peripheral edema (swelling of ankles and feet), and fatigue. Dizziness is often more noticeable when starting or increasing the dose. Most side effects are mild and tend to improve as your body adjusts to the medicine. Contact your doctor if side effects persist or become bothersome.
It is advisable to limit or avoid alcohol while taking Dafiro HCT. Alcohol can enhance the blood pressure-lowering effect, increasing the risk of dizziness, lightheadedness, and fainting. If you choose to drink, do so in moderation and be mindful of how it affects you, particularly when standing up quickly.
If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Never take a double dose to make up for a forgotten tablet. Setting a daily alarm can help you remember to take your medicine consistently.
Dafiro HCT begins to lower blood pressure within a few hours of the first dose. However, the full therapeutic effect usually develops over 2 to 4 weeks of regular use. Continue taking the medicine as prescribed even if you feel well, since high blood pressure often has no noticeable symptoms. Your doctor will monitor your blood pressure and may adjust your dose if needed.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Dafiro HCT – Summary of Product Characteristics (SmPC). Last updated 2025. Available at: www.ema.europa.eu
- Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension. Journal of Hypertension. 2023;41(12):1874–2071. doi:10.1097/HJH.0000000000003480
- Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018;39(33):3021–3104. doi:10.1093/eurheartj/ehy339
- World Health Organization (WHO). Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: www.who.int
- Calhoun DA, Lacourcière Y, Chiang YT, Glazer RD. Triple antihypertensive therapy with amlodipine, valsartan, and hydrochlorothiazide: a randomized clinical trial. Hypertension. 2009;54(1):32–39. doi:10.1161/HYPERTENSIONAHA.109.131300
- Joint National Committee (JNC 8). 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults. JAMA. 2014;311(5):507–520. doi:10.1001/jama.2013.284427
- British National Formulary (BNF). Amlodipine with valsartan and hydrochlorothiazide. NICE, 2025. Available at: bnf.nice.org.uk
- U.S. Food and Drug Administration (FDA). Exforge HCT Prescribing Information. Available at: www.fda.gov
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians specializing in clinical pharmacology, cardiology, and internal medicine. Our team follows international guidelines from the WHO, EMA, FDA, and ESC/ESH to ensure all information is accurate, evidence-based, and up to date.
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