FDA-filed SPL labeling · retrieved through openFDA

Eslicarbazepine

Eslicarbazepine is an antiseizure medicine used to treat partial-onset seizures in adults and children 4 years and older.

Brand name Aptiom
Drug classes ⓘ Cytochrome P450 2c19 Inhibitors
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 10 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 effectiveNov 10, 2023
Clinical labels in scope ⓘ10
AvailabilityRx
Earliest approval/marketing year ⓘ2013
FDA-listed product records ⓘ70
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Eslicarbazepine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Eslicarbazepine acetate (Aptiom) is a once-daily oral antiseizure tablet approved for partial-onset seizures in adults and children 4 and older, used alone or with other seizure medicines. It generally works well and is convenient to take with or without food, but never stop it suddenly. Watch for mood changes, skin reactions, low sodium symptoms, and check with your pharmacist about any hormonal birth control or other antiseizure medicines you take.
How we write & review this content — our editorial policy →

📖 Eslicarbazepine: Patient Information Guide

A plain-language walkthrough of Eslicarbazepine — 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▾

Eslicarbazepine acetate is an antiseizure medicine approved for the following use across its supported products:

  • Aptiom (eslicarbazepine acetate tablet, oral) is indicated for the treatment of partial-onset seizures in patients 4 years of age and older — as monotherapy (the only antiseizure medicine) or as adjunctive therapy (added to other antiseizure medicines).
  • Eslicarbazepine Acetate tablets (oral) are indicated for the treatment of partial-onset seizures in patients 4 years of age and older — as monotherapy or adjunctive therapy.
⚙️How it works▾

When you take an eslicarbazepine acetate tablet, your body rapidly converts almost all of it into its active form, eslicarbazepine, which does the therapeutic work. Eslicarbazepine is believed to block voltage-gated sodium channels — tiny gatekeepers in nerve cell membranes that control electrical signals. By stabilizing these channels and preventing them from firing abnormally, eslicarbazepine reduces the runaway electrical activity in the brain that produces partial-onset seizures.

💊How it's taken▾

Eslicarbazepine acetate tablets are taken orally, once a day, with or without food. In adults, the prescriber typically starts at a lower dose and increases it in weekly steps until the best balance of seizure control and tolerability is reached. In children ages 4 to 17, the dose is based on body weight and also increased gradually. Patients with significant kidney impairment generally need a lower dose. Never stop this medicine abruptly — your prescriber will slowly taper your dose to avoid triggering increased seizures or a prolonged seizure emergency called status epilepticus.

🤒Side effects — in detail▾

The most commonly reported side effects with eslicarbazepine acetate tablets include:

  • Dizziness
  • Sleepiness (somnolence)
  • Nausea or vomiting
  • Headache
  • Double vision (diplopia)
  • Fatigue
  • Unsteady walking or poor coordination (ataxia)
  • Blurred vision or a spinning sensation (vertigo)
  • Tremor

Serious reactions — including severe skin blistering, signs of a major allergic reaction, low blood sodium, liver injury, suicidal thoughts, or unusual bruising and infections — require prompt medical attention. Contact your doctor or seek emergency care right away if any of these occur.

⚠️Warnings & precautions▾
  • Suicidal thoughts and behavior: All antiseizure medicines, including eslicarbazepine acetate, increase the risk of suicidal thinking or behavior. This can begin within the first week of treatment. Report any new depression, mood changes, or thoughts of self-harm to a healthcare provider immediately.
  • Serious skin reactions: Rare, potentially fatal skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. Stop the medicine and get urgent care if severe skin blistering or peeling develops.
  • DRESS (severe multi-organ allergic reaction): Fever, rash, swollen lymph nodes, and organ involvement can signal this life-threatening reaction. Discontinue the medicine if DRESS is suspected.
  • Anaphylaxis and angioedema: Rare cases of sudden severe allergic reactions and dangerous throat swelling have occurred. Seek emergency care immediately.
  • Low sodium (hyponatremia): Clinically significant drops in blood sodium have been reported. Watch for confusion, swelling, or unusual fatigue, especially in people at risk.
  • Liver injury: Stop the medicine and contact your doctor if you develop yellow skin or eyes, or other signs of liver trouble.
  • Thyroid changes: Dose-related decreases in thyroid hormone levels have been seen; abnormal thyroid tests should be evaluated by your doctor.
  • Blood cell problems: Rare but serious decreases in blood cell counts (including agranulocytosis and pancytopenia) have been reported after marketing; discontinuation may be needed.
🔀What it interacts with▾

Eslicarbazepine acetate can interact with several other medicines — always tell your prescriber and pharmacist everything you take:

  • Carbamazepine: Lowers eslicarbazepine blood levels, and the combination increases the risk of side effects; doses of either drug may need adjustment.
  • Phenytoin, phenobarbital, primidone: These enzyme-inducing antiseizure drugs reduce eslicarbazepine levels, so a higher eslicarbazepine dose may be needed. Eslicarbazepine can also raise phenytoin levels, requiring a phenytoin dose reduction.
  • Oxcarbazepine: Should not be used together with eslicarbazepine acetate as adjunctive therapy.
  • Hormonal contraceptives (ethinylestradiol/levonorgestrel): Eslicarbazepine lowers hormone levels and can make birth control pills, patches, and rings less effective — use additional or non-hormonal contraception.
  • Clobazam and omeprazole: Eslicarbazepine can raise blood levels of these drugs, possibly requiring dose adjustments.
  • Simvastatin and lovastatin: Eslicarbazepine can lower levels of these cholesterol medicines; monitoring and dose adjustment may be needed.

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▾
  • Allergy to eslicarbazepine or oxcarbazepine: Do not take this medicine if you have had a hypersensitivity reaction to either of these drugs — it is contraindicated.
  • Previous serious skin reaction or DRESS with oxcarbazepine or eslicarbazepine: Do not use eslicarbazepine acetate.
  • Kidney disease: Dose reduction is needed if creatinine clearance is below 50 mL/min. Patients on dialysis should be monitored closely.
  • Severe liver disease: Eslicarbazepine acetate has not been studied in severe hepatic impairment and is not recommended in these patients.
  • Pregnancy: Animal studies showed fetal harm including malformations, embryo loss, and growth problems. Tell your doctor if you are pregnant or planning to become pregnant. Consider enrolling in the NAAED Pregnancy Registry (1-888-233-2334).
  • Breastfeeding: Eslicarbazepine passes into breast milk; discuss the risks and benefits with your doctor.
  • Hormonal contraception users: Eslicarbazepine reduces hormone levels — use additional or alternative non-hormonal birth control.
  • Children under 4: Safety and effectiveness have not been established in this age group.
  • Older adults: Age alone does not require a dose change, but older patients are more likely to have reduced kidney function, which does require dose adjustment.
🚑If you take too much▾

Taking too much eslicarbazepine acetate can cause symptoms including severe low sodium (hyponatremia), dizziness, nausea, vomiting, extreme drowsiness, unsteady walking, double vision, and a feeling of numbness or tingling in the mouth. There is no specific antidote — treatment focuses on supportive care, and a healthcare team may consider stomach lavage, activated charcoal, or hemodialysis (which can partially remove the drug) depending on the situation. If you suspect an overdose, call emergency services or poison control immediately.

📡Pharmacodynamics — effects in the body▾

Eslicarbazepine acetate tablets have been studied for effects on the heart's electrical activity (specifically the QTc interval, a measure of heart rhythm). At the doses studied, no meaningful effect on the QTc interval was detected, suggesting the drug does not significantly alter heart rhythm at therapeutic or higher doses.

🔬Pharmacokinetics — how your body processes it▾

After swallowing an eslicarbazepine acetate tablet, the body converts it almost entirely into its active form, eslicarbazepine, which peaks in the blood within 1 to 4 hours in adults (1 to 3 hours in children). The drug stays in the body for a relatively long time — its half-life (the time for blood levels to drop by half) is 13 to 20 hours in adults and 10 to 16 hours in children — which is why once-daily dosing works well. Steady, stable blood levels are typically reached after 4 to 5 days of once-daily dosing. Eslicarbazepine is mainly cleared through the kidneys, so reduced kidney function leads to higher drug levels in the body and requires a lower dose.

📦How to store it▾

Store eslicarbazepine acetate tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Eslicarbazepine’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 →

37

Supplements & herbs that interact with Eslicarbazepine

37 supplements and herbal products have documented interactions with Eslicarbazepine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 27
  • Minor · 9
ACTIVATED CHARCOAL Major ALKANNA Moderate ALPINE RAGWORT Moderate BONESET Moderate BORAGE Moderate BUTTERBUR Moderate CANNABIDIOL (CBD) Moderate CANNABIS Moderate +29 more
Every supplement checked against Eslicarbazepine — ranked by severity The full interaction hub: 1 major · 27 moderate · 9 minor · every one linked to its full report. Check Eslicarbazepine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What exactly is this medicine for? My doctor said it's for seizures — can you tell me more? ▾
Sure. Eslicarbazepine acetate (brand name Aptiom) is specifically approved to treat partial-onset seizures — that's when a seizure starts in just one area of the brain rather than involving the whole brain all at once. It's approved for both adults and kids as young as 4 years old. Your doctor may have you take it on its own or alongside another seizure medicine, depending on what works best for you.
Can I take this pill with food, or does it have to be on an empty stomach? ▾
Good news — food doesn't affect how this medicine works, so you can take it with or without a meal, whichever is easier for you. It's taken just once a day, which most people find convenient. If swallowing the tablet whole is difficult, you can crush it.
What side effects should I expect, and which ones should make me call my doctor? ▾
The most common ones are dizziness, sleepiness, nausea, headache, and sometimes blurred or double vision — especially when you first start or when your dose goes up. These often improve as your body adjusts. What you really need to call about right away: any skin blistering or peeling, fever with a rash, swelling of the face or throat, trouble breathing, yellowing of your skin or eyes, or any new feelings of depression or thoughts of self-harm. Don't wait on those — they need to be checked urgently.
I use birth control pills. Is that a problem with this medicine? ▾
Yes, this is important to know. Eslicarbazepine acetate can lower the hormone levels in birth control pills, patches, and rings — which means they may not work as well at preventing pregnancy. Talk to your doctor or pharmacist about using a backup method or switching to a non-hormonal form of birth control while you're on this medicine.
What happens if I miss a dose or decide to stop taking it? ▾
If you miss a dose, take it as soon as you remember — unless it's almost time for your next dose, in which case just skip the missed one and carry on as usual. Never double up. And please don't stop this medicine suddenly on your own. Stopping abruptly can cause your seizures to come back more severely or trigger a dangerous prolonged seizure called status epilepticus. If you want to stop, your doctor will create a plan to slowly taper your dose.
Is it safe to take this medicine if I'm pregnant or thinking about getting pregnant? ▾
This is a conversation you really need to have with your doctor. Animal studies did show potential risks to a developing baby, including birth defects and growth problems, so there is a concern. That said, uncontrolled seizures during pregnancy carry their own risks. Your doctor will help you weigh both sides. If you become pregnant while taking this medicine, there's a pregnancy registry you can join to help track outcomes — your doctor can give you the number.
Is Eslicarbazepine available over the counter? ▾
Eslicarbazepine 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 Eslicarbazepine first available? ▾
Eslicarbazepine has been available in the United States since at least 2013, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Eslicarbazepine? ▾
Eslicarbazepine is supplied by 23 manufacturers listed in the FDA NDC Directory, including Apotex Corp., Camber Pharmaceuticals, Inc., Aurobindo Pharma Limited.

💬 Answers drafted from Eslicarbazepine’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

📊Eslicarbazepine supplement interactions37 checked — ranked by severity 🌿Drug & Supplement CheckerEslicarbazepine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Eslicarbazepine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Eslicarbazepine comes

Eslicarbazepine 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 Aptiom
How this form is used
What it may be used for
  • Aptiom tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older, as monotherapy or adjunctive therapy.
  • Eslicarbazepine Acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older, as monotherapy or adjunctive therapy.
Important instructions
  • Both Aptiom and Eslicarbazepine Acetate tablets can be swallowed whole or crushed.
  • Both Aptiom and Eslicarbazepine Acetate tablets can be taken with or without food.
  • Aptiom and Eslicarbazepine Acetate tablets are each taken once daily; dose is adjusted based on age, body weight, and kidney function.
  • Do not stop Aptiom or Eslicarbazepine Acetate tablets abruptly — your prescriber will guide a gradual taper to reduce the risk of worsening seizures.
Available strengths 4 strengths
200 mg 400 mg 600 mg 800 mg
56 FDA-listed product records ⓘ

📊 Eslicarbazepine across the U.S. market

How Eslicarbazepine 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 ⓘ
23
Manufacturers
2
Brand names
70
FDA-listed product records ⓘ
2013
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (12) · Kit (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp.11%
Camber Pharmaceuticals, Inc.11%
Aurobindo Pharma Limited7%
Sunovion Pharmaceuticals Inc.7%
Sumitomo Pharma America, Inc.7%
Ascend Laboratories, LLC6%
Other makers50%

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

📈 How widely Eslicarbazepine is used

A general measure of how commonly Eslicarbazepine 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 Eslicarbazepine 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.

50,618
Medicaid prescriptions filled (Q1–Q4 2025)
$82.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Eslicarbazepine prescribed? Of the 1,596 medications we measure, Eslicarbazepine ranks #633 by Medicaid prescriptions — more than 60% of them.

Where Eslicarbazepine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #633 of 1,596
#628 Elexacaftor, Tezacafto... 51,835 Rx #629 Naratriptan 51,801 Rx #630 Neomycin, Polymyxin, a... 51,532 Rx #631 Abacavir, Dolutegravir... 51,277 Rx #632 Pembrolizumab Injectio... 51,156 Rx #633 Eslicarbazepine 50,618 Rx #634 Pegfilgrastim Injectio... 50,322 Rx #635 Pyridostigmine 50,282 Rx #636 Capsaicin 49,268 Rx #637 Suvorexant 49,093 Rx #638 Emtricitabine, Rilpivi... 48,910 Rx

Utilization by Eslicarbazepine 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 800 mg oral tablet is the most-dispensed Eslicarbazepine product — about 48% of these Medicaid prescriptions.

eslicarbazepine acetate 800 MG Oral Tablet Most dispensed

24,519 Medicaid prescriptions (Q1–Q4 2025) 48% of Eslicarbazepine prescriptions shown $37M gross reimbursement (before rebates) ≈ $1,510 per prescription (gross)

Summed across the 7 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482525

eslicarbazepine acetate 600 MG Oral Tablet

13,643 Medicaid prescriptions (Q1–Q4 2025) 27% of Eslicarbazepine prescriptions shown $24.7M gross reimbursement (before rebates) ≈ $1,807 per prescription (gross)

Summed across the 7 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482521

eslicarbazepine acetate 400 MG Oral Tablet

8,850 Medicaid prescriptions (Q1–Q4 2025) 17% of Eslicarbazepine prescriptions shown $14.2M gross reimbursement (before rebates) ≈ $1,603 per prescription (gross)

Summed across the 7 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482515

eslicarbazepine acetate 200 MG Oral Tablet

3,606 Medicaid prescriptions (Q1–Q4 2025) 7% of Eslicarbazepine prescriptions shown $6.2M gross reimbursement (before rebates) ≈ $1,715 per prescription (gross)

Summed across the 7 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482507

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 Eslicarbazepine, 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 28 of 83 listed Eslicarbazepine NDCs with Medicaid activity.

🔍 Compare Eslicarbazepine products

A representative set of FDA-listed product records for Eslicarbazepine — 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 70 of 70 products — FDA National Drug Code Directory. See every product, package size and price: browse all 70 Eslicarbazepine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Eslicarbazepine RxCUI 1482502 1 dose form · 4 strengths

Look up RxCUI 1482502 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

Aptiom

🏭 Manufacturers & labelers

Apotex Corp. 8 Camber Pharmaceuticals, Inc. 8 Aurobindo Pharma Limited 5 Sunovion Pharmaceuticals Inc. 5 Sumitomo Pharma America, Inc. 5 Ascend Laboratories, LLC 4 Torrent Pharmaceuticals Limited 4 Patheon Inc. 4 Lupin Pharmaceuticals, Inc. 4 Jubilant Cadista Pharmaceuticals Inc. 4 Golden State Medical Supply, Inc. 4 Dr.Reddys Laboratories Inc 4 Hubei Gedian humanwell Pharmaceutical Co., Ltd 1 Hubei Gedian Humanwell Pharmaceutical Co., Ltd. 1 Jubilant Biosys limited 1 Lupin Manufacturing Solutions Limited 1 Dr.Reddy's Laboratories Limited 1 MSN Life Sciences Private Limited 1 Dasami Lab Private Limited 1 Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. 1 CTX Lifesciences Pvt. Ltd. 1 Cohance Lifesciences Limited 1 Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd. 1

RxNorm drug class

Eslicarbazepine belongs to the Carboxamide derivatives class.

Drug family (ATC) Carboxamide derivatives
How it works Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers

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 Nov 10, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Eslicarbazepine.
📈
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 Eslicarbazepine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
NDC products indexed
70
Distinct labelers/manufacturers represented
23
Linked representative label ⓘ
Sunovion Pharmaceuticals Inc.
Linked label effective
Nov 10, 2023
Composite sections available
27
Linked SPL Set ID
3d0c9554-eaeb-4694-8089-00133fcadce3
Linked SPL Document ID
3af99c5d-50e2-4336-8a5e-e93b6cf3618a
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 10 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. Sunovion Pharmaceuticals Inc. 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.