FDA-filed SPL labeling · retrieved through openFDA

Amlodipine / Valsartan

Amlodipine/valsartan is a combination tablet that treats high blood pressure (hypertension) by working through two different mechanisms to lower the risk of stroke and heart attack.

Brand name Exforge
Drug class ⓘ Angiotensin 2 Receptor Blocker
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 17, 2026
Clinical labels in scope ⓘ11
AvailabilityRx
Earliest approval/marketing year ⓘ2007
FDA-listed product records ⓘ104
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 29, 2026
⭐ Amlodipine / Valsartan at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Amlodipine and valsartan is an effective combination tablet for treating high blood pressure, working through two complementary pathways to help more patients reach their blood pressure goals. It must never be taken during pregnancy due to serious risk of fetal harm. Most people tolerate it well, but regular monitoring of blood pressure, kidney function, and potassium is important during treatment.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

WARNING: This medicine can harm or kill an unborn baby. Amlodipine and valsartan tablets affect the renin-angiotensin system — a hormone system that the developing fetus depends on for kidney development. Using this medicine during the second or third trimester of pregnancy can cause serious fetal kidney damage, low amniotic fluid, lung underdevelopment, skull defects, and even fetal or newborn death. If you become pregnant while taking this medicine, stop it immediately and call your doctor. Talk to your doctor about safe alternatives to control blood pressure if you are pregnant or planning to become pregnant.

Read the full warning on DailyMed →

📖 Amlodipine / Valsartan: Patient Information Guide

A plain-language walkthrough of Amlodipine / Valsartan — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Amlodipine and valsartan is a combination tablet used to treat high blood pressure (hypertension) in adults.

  • Treats high blood pressure in patients whose blood pressure is not adequately controlled on either amlodipine or valsartan alone
  • Can be used as initial (starting) combination therapy when a single blood pressure medicine is unlikely to be sufficient
  • Lowering blood pressure with this medicine reduces the risk of strokes and heart attacks
  • May be used alongside other antihypertensive agents when additional blood pressure control is needed
⚙️How it works▾

Amlodipine and valsartan lower blood pressure through two different but complementary mechanisms. Amlodipine is a calcium channel blocker — it prevents calcium from entering the walls of blood vessels, which relaxes the vessels and reduces the resistance blood has to flow against, lowering blood pressure. Valsartan is an angiotensin II receptor blocker (ARB) — it blocks a hormone called angiotensin II from binding to its receptor, preventing the blood vessel tightening and sodium retention that angiotensin II normally causes. Because these two mechanisms work independently, using them together produces a greater blood pressure reduction than either drug alone.

💊How it's taken▾

Amlodipine and valsartan tablets are taken once daily by mouth. They can be taken with or without food, so take them whichever way works best for you. The dose may be adjusted by your doctor after 1–2 weeks based on how your blood pressure responds. Always follow your prescriber's specific instructions — do not adjust your dose on your own.

  • Take at the same time each day to help remember
  • If you miss a dose, take it as soon as you remember — but if it's almost time for your next dose, skip the missed one; do not double up
🤒Side effects — in detail▾

Most people tolerate this medicine well. The most common side effects include:

  • Swelling in the legs or feet (peripheral edema) — the most common reason people stop the medicine
  • Dizziness or lightheadedness
  • Runny nose, sore throat, or upper respiratory infections
  • Headache
  • Flushing or feeling hot
  • Fatigue
  • Nausea, diarrhea, or stomach discomfort
  • Palpitations (feeling your heart beat)

Seek medical attention right away for serious reactions: severe low blood pressure (fainting, extreme dizziness), sudden swelling of the face or throat (angioedema), chest pain, very little or no urination, or muscle weakness that could signal high potassium levels.

⚠️Warnings & precautions▾
  • Fetal harm (most critical): This medicine can injure or kill an unborn baby. Stop it immediately if you become pregnant and contact your doctor. Do not use during the second or third trimester of pregnancy.
  • Low blood pressure (hypotension): Risk is higher if you are dehydrated, on high-dose diuretics, or have heart failure. Correct dehydration before starting and begin therapy under medical supervision.
  • Kidney problems: Can cause worsening kidney function or acute kidney failure, especially in people with kidney artery disease, chronic kidney disease, severe heart failure, or volume depletion. Monitor kidney function periodically.
  • High potassium (hyperkalemia): Valsartan can raise potassium levels. Monitor electrolytes, especially in patients with kidney impairment or heart failure.
  • Worsening chest pain or heart attack: In patients with severe coronary artery disease, starting or increasing amlodipine has rarely triggered worsening angina or a heart attack.
🔀What it interacts with▾

Several drugs and substances can interact with amlodipine and valsartan, affecting how the medicine works or raising the risk of side effects:

  • CYP3A inhibitors (e.g., diltiazem, itraconazole, clarithromycin) — increase amlodipine blood levels, raising the risk of low blood pressure and swelling; dose adjustment may be needed
  • CYP3A inducers (e.g., rifampin, St. John's Wort) — may lower amlodipine effectiveness; blood pressure should be closely monitored
  • Simvastatin — amlodipine significantly increases simvastatin exposure; the simvastatin dose should not exceed 20 mg daily
  • Sildenafil — both this medicine and sildenafil lower blood pressure independently; use together with caution and monitor for hypotension
  • Cyclosporine and tacrolimus — amlodipine can raise levels of these transplant medicines; frequent blood level monitoring is recommended
  • Potassium-raising drugs (potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, heparin) — combined with valsartan, can cause dangerously high potassium levels
  • NSAIDs (ibuprofen, naproxen, COX-2 inhibitors) — can reduce the blood pressure-lowering effect and increase the risk of kidney problems, especially in older adults or those with kidney disease
  • Lithium — valsartan can increase lithium levels, raising the risk of lithium toxicity; lithium blood levels should be monitored
  • Aliskiren — do not combine with this medicine in patients with diabetes; avoid in patients with a creatinine clearance below 60 mL/min

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Pregnancy: Do not take this medicine if you are pregnant or planning to become pregnant — it can cause serious fetal injury or death. Discuss safe alternatives with your doctor.
  • Breastfeeding: Breastfeeding is not recommended while taking this medicine.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults: Amlodipine clears more slowly in older adults. This combination is generally not recommended as the first choice for starting therapy in elderly patients due to the unavailability of the lower recommended starting dose of amlodipine in this combination form.
  • Kidney disease: Patients with mild-to-moderate kidney impairment generally do not need dose adjustments, but patients with severe kidney impairment require careful monitoring. Kidney function should be monitored periodically.
  • Liver disease: This combination is generally not recommended as initial therapy in patients with hepatic impairment.
  • Allergy: Do not take if you have a known allergy to any ingredient in this tablet.
  • Diabetes: Do not combine with aliskiren if you have diabetes.
  • Heart failure or recent heart attack: Use with caution; begin therapy under close medical supervision.
🚑If you take too much▾

Taking too much amlodipine can cause severe, prolonged low blood pressure and, in serious cases, shock. Too much valsartan can also cause low blood pressure, and rarely a slowed or racing heart rate. If an overdose is suspected, seek emergency medical help immediately. Because amlodipine is highly protein-bound, hemodialysis is unlikely to remove it from the body, and valsartan is also not removed by hemodialysis.

📡Pharmacodynamics — effects in the body▾

In patients with high blood pressure, amlodipine produces widening of blood vessels (vasodilation), reducing the resistance the heart pumps against and lowering blood pressure in both lying-down and standing positions — without significantly changing heart rate. The effect lasts at least 24 hours with once-daily dosing. Valsartan blocks angiotensin II from raising blood pressure, and an oral dose substantially inhibits this effect at peak with partial effect persisting through 24 hours. Together, both components reduce peripheral resistance through complementary and independent mechanisms, providing an additive blood pressure-lowering effect.

🔬Pharmacokinetics — how your body processes it▾

After taking amlodipine and valsartan tablets together, peak blood levels of valsartan are reached in about 3 hours and amlodipine in about 6–8 hours. Food does not meaningfully affect the absorption of either component from the combination tablet, so it can be taken with or without meals. Amlodipine has a long half-life of 30–50 hours and is extensively broken down by the liver, with steady-state levels reached after 7–8 days of daily dosing. Valsartan has a shorter half-life of about 6 hours, is mostly eliminated unchanged via feces, and is not significantly metabolized by CYP450 enzymes, making drug interactions through that pathway unlikely. Neither component is effectively removed by hemodialysis.

📦How to store it▾

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

📄 Written from Amlodipine / Valsartan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Amlodipine / Valsartan — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine actually for, and why am I taking two drugs in one pill? ▾
This tablet combines two different blood pressure medicines — amlodipine and valsartan — into a single pill. They each lower blood pressure in a different way, and together they're more effective than either one alone. Your doctor prescribed the combination either because one medicine wasn't bringing your blood pressure down far enough, or because your blood pressure needed a bigger reduction from the start. Keeping blood pressure under control helps protect you from strokes and heart attacks over time.
Does it matter if I take this with food or on an empty stomach? ▾
No — you can take amlodipine and valsartan tablets (including Exforge) with or without food. Pick whatever works best for your routine and try to take it at the same time every day. Consistency is more important than what you eat with it.
What side effects should I expect, and which ones mean I should call my doctor? ▾
The most common things people notice are swelling in the legs or feet, dizziness, a runny nose, or mild headache. These are usually manageable and often improve over time. Call your doctor right away if you feel faint or have severe dizziness (signs of very low blood pressure), notice your ankles swelling a lot, develop chest pain, or have very little urination — that last one can signal a kidney issue. And if your face, lips, or throat start swelling suddenly, get emergency help immediately — that's a rare but serious reaction called angioedema.
I'm on a few other medications — are there any I should be especially careful about? ▾
Yes, a few interactions are worth knowing about. If you take the cholesterol medicine simvastatin, your doctor may need to limit its dose because amlodipine raises simvastatin levels in the blood. NSAIDs like ibuprofen or naproxen — even over-the-counter ones — can weaken this medicine's blood pressure effect and put extra strain on your kidneys, so use them sparingly and check with your pharmacist first. Potassium supplements or salt substitutes containing potassium can raise your potassium to unsafe levels when combined with valsartan. And if you're on lithium, your levels will need to be monitored. Always mention every medicine, supplement, and herbal product to your doctor and pharmacist.
I just found out I'm pregnant. What should I do? ▾
Stop taking this medicine right away and call your doctor today — this is urgent. Amlodipine and valsartan can seriously injure or even be fatal to a developing baby, particularly in the second and third trimesters. Your doctor will switch you to a blood pressure medicine that's safe to use during pregnancy. This isn't meant to alarm you, but acting quickly is important.
How long will it take to see if this medicine is working? ▾
Most people get the majority of the blood pressure-lowering benefit within about two weeks of starting the medicine or after a dose change. Your doctor will likely check your blood pressure at follow-up visits to see how you're responding and whether any adjustment is needed. Don't stop taking the medicine on your own even if you feel fine — high blood pressure usually causes no symptoms, but it still raises your risk of stroke and heart attack if it stays uncontrolled.
Is Amlodipine / Valsartan available over the counter? ▾
Amlodipine / Valsartan is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Amlodipine / Valsartan first available? ▾
Amlodipine / Valsartan has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Amlodipine / Valsartan? ▾
Amlodipine / Valsartan is supplied by 12 manufacturers listed in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation, Alembic Pharmaceuticals Inc., Strides Pharma Science Limited.

💬 Answers drafted from Amlodipine / Valsartan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerAmlodipine / Valsartan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Amlodipine / Valsartan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Amlodipine / Valsartan comes

Amlodipine / Valsartan is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Exforge
How this form is used
What it may be used for
  • Amlodipine and Valsartan tablets treat high blood pressure in adults whose blood pressure is not adequately controlled on a single medicine
  • Exforge treats high blood pressure and may be used as initial therapy in patients likely to need more than one drug to reach their blood pressure goal
  • Amlodipine and Valsartan tablets may also be used as initial combination therapy when a single agent is unlikely to be enough
Important instructions
  • Take once daily by mouth, with or without food
  • Exforge and Amlodipine and Valsartan tablets may be taken alongside other blood pressure medicines if your doctor prescribes them together
  • Most of the blood pressure-lowering effect occurs within 2 weeks of starting or changing the dose
  • Patients switching from two separate tablets of amlodipine and valsartan may use Exforge or Amlodipine and Valsartan tablets at the same component doses for convenience
Available strengths 4 strengths
5 mg / 160 mg 5 mg / 320 mg 10 mg / 160 mg 10 mg / 320 mg
104 FDA-listed product records ⓘ

📊 Amlodipine / Valsartan across the U.S. market

How Amlodipine / Valsartan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
12
Manufacturers
2
Brand names
104
FDA-listed product records ⓘ
2007
First marketed ⓘ
Novartis Pharmaceuticals Corporation14%
Alembic Pharmaceuticals Inc.12%
Strides Pharma Science Limited12%
Aurobindo Pharma Limited12%
Mylan Pharmaceuticals Inc.8%
Lupin Pharmaceuticals,Inc.8%
Other makers36%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Amlodipine / Valsartan is used

A general measure of how commonly Amlodipine / Valsartan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Amlodipine / Valsartan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

77,462
Medicaid prescriptions filled (Q1–Q4 2025)
$2.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Amlodipine / Valsartan prescribed? Of the 1,597 medications we measure, Amlodipine / Valsartan ranks #550 by Medicaid prescriptions — more than 66% of them.

Where Amlodipine / Valsartan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #550 of 1,597
#545 Crisaborole Topical 80,367 Rx #546 Gadobutrol 80,211 Rx #547 Alfuzosin 80,100 Rx #548 Potassium Citrate 79,544 Rx #549 Methotrexate Injection 78,302 Rx #550 Amlodipine / Valsartan 77,462 Rx #551 Rifampin 77,313 Rx #552 Clindamycin Vaginal 76,615 Rx #553 Ruxolitinib Topical 76,226 Rx #554 Calcipotriene Topical 74,990 Rx #555 Clotrimazole Vaginal 73,195 Rx

Utilization by Amlodipine / Valsartan product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg / 160 mg oral tablet is the most-dispensed Amlodipine / Valsartan product — about 38% of these Medicaid prescriptions.

amlodipine 5 MG / valsartan 160 MG Oral Tablet Most dispensed

29,388 Medicaid prescriptions (Q1–Q4 2025) 38% of Amlodipine / Valsartan prescriptions shown $981,046 gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 8 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722134

amlodipine 10 MG / valsartan 320 MG Oral Tablet

21,549 Medicaid prescriptions (Q1–Q4 2025) 28% of Amlodipine / Valsartan prescriptions shown $927,173 gross reimbursement (before rebates) ≈ $43 per prescription (gross)

Summed across the 8 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722131

amlodipine 10 MG / valsartan 160 MG Oral Tablet

20,142 Medicaid prescriptions (Q1–Q4 2025) 26% of Amlodipine / Valsartan prescriptions shown $702,859 gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 8 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722126

amlodipine 5 MG / valsartan 320 MG Oral Tablet

6,383 Medicaid prescriptions (Q1–Q4 2025) 8% of Amlodipine / Valsartan prescriptions shown $248,808 gross reimbursement (before rebates) ≈ $39 per prescription (gross)

Summed across the 7 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722137

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amlodipine / Valsartan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 31 of 132 listed Amlodipine / Valsartan NDCs with Medicaid activity.

🔍 Compare Amlodipine / Valsartan products

A representative set of FDA-listed product records for Amlodipine / Valsartan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 104 of 104 products — FDA National Drug Code Directory. See every product, package size and price: browse all 104 Amlodipine / Valsartan NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Amlodipine / Valsartan RxCUI 729455 1 dose form · 4 strengths

Look up RxCUI 729455 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Exforge

🏭 Manufacturers & labelers

Novartis Pharmaceuticals Corporation 15 Alembic Pharmaceuticals Inc. 12 Strides Pharma Science Limited 12 Aurobindo Pharma Limited 12 Mylan Pharmaceuticals Inc. 8 Lupin Pharmaceuticals,Inc. 8 Alembic Pharmaceuticals Limited 8 Lupin Pharmaceuticals, Inc. 8 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 8 Golden State Medical Supply, Inc. 8 Macleods Pharmaceuticals Limited 4 A-S Medication Solutions 1

RxNorm drug class

Amlodipine / Valsartan belongs to the Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker, Calcium Channel Blocker
Drug family (ATC) Renin-inhibitors, ACE inhibitors and calcium channel blockers, Dihydropyridine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 3A Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 17, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Amlodipine / Valsartan.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Amlodipine / Valsartan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
NDC products indexed
104
Distinct labelers/manufacturers represented
12
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
Feb 17, 2026
Composite sections available
23
Linked SPL Set ID
d0caec89-96ec-411d-a933-63eda74a6da7
Linked SPL Document ID
7e675018-c404-4ea5-ac95-a18d7cb78301
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 11 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.