FDA-filed SPL labeling · retrieved through openFDA

Nitisinone

Nitisinone is an enzyme-blocking medication used to treat hereditary tyrosinemia type 1 (HT-1), a rare inherited metabolic disorder, and — as Harliku — to reduce a harmful acid buildup in adults with alkaptonuria (AKU), another inherited metabolic condition.

Brand names OrfadinNityrHarliku
Drug class ⓘ 4-hydroxyphenyl-pyruvate Dioxygenase Inhibitor
Rx Forms 3 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 15, 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 effectiveDec 22, 2025
Clinical labels in scope ⓘ10
AvailabilityRx
Earliest approval/marketing year ⓘ2002
FDA-listed product records ⓘ60
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Nitisinone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Nitisinone is a specialized medication for rare inherited metabolic disorders — primarily hereditary tyrosinemia type 1 (HT-1), and in the case of Harliku, alkaptonuria (AKU). It must always be paired with strict dietary management and regular medical monitoring, including blood tests and eye exams. When used correctly under close medical supervision, it can prevent life-threatening complications of these conditions.
How we write & review this content — our editorial policy →

📖 Nitisinone: Patient Information Guide

A plain-language walkthrough of Nitisinone — 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▾

Nitisinone is approved for two distinct rare inherited metabolic conditions, depending on the product:

  • Hereditary tyrosinemia type 1 (HT-1) — treated with Orfadin capsules, Orfadin oral suspension, Nityr tablets, and nitisinone capsules, in both adults and children. Always used together with a strict low-tyrosine, low-phenylalanine diet.
  • Alkaptonuria (AKU) — Harliku tablets are approved specifically for adult patients to reduce urine levels of homogentisic acid (HGA), the harmful substance that accumulates in AKU.
⚙️How it works▾

Nitisinone works by blocking an enzyme called 4-hydroxyphenyl-pyruvate dioxygenase — a key step in the body's tyrosine breakdown pathway. In HT-1, blocking this enzyme prevents the formation of toxic compounds (succinylacetone and related substances) that damage the liver and kidneys and can trigger serious neurological crises called porphyric crises. In alkaptonuria, the same blockade reduces the production of homogentisic acid, the substance responsible for harm in AKU.

Because nitisinone blocks tyrosine breakdown, tyrosine itself can accumulate in the blood. This is why a strict low-tyrosine, low-phenylalanine diet is essential during treatment — without it, high tyrosine levels can cause their own serious complications.

💊How it's taken▾

The dose and frequency of nitisinone depend on the product, the condition being treated, and your body weight. For HT-1, treatment typically starts twice daily and may be switched to once daily in eligible patients after at least four weeks of stable therapy. For alkaptonuria, Harliku is taken once daily. No specific milligram doses are listed here — your prescriber will calculate the right amount for you and adjust it over time based on lab results.

  • Orfadin capsules and nitisinone capsules: take at least one hour before or two hours after a meal
  • Orfadin oral suspension: can be taken without regard to meals
  • Nityr and Harliku tablets: can be taken with or without food
  • If you miss a dose, skip it and take your next dose at the usual time — never double up
🤒Side effects — in detail▾

The most common side effect of nitisinone is elevated tyrosine levels in the blood, which is why dietary restriction is so important. Other side effects reported in clinical trials include:

  • Low white blood cell count (leukopenia) and low platelet count (thrombocytopenia)
  • Eye problems: conjunctivitis, corneal opacity, keratitis, light sensitivity, eye pain, blepharitis, cataracts
  • Skin reactions: itching, dry skin, maculopapular rash, exfoliative dermatitis, hair loss
  • Nosebleeds

Serious reactions — including eye damage, liver complications, liver tumors, porphyric crises, and very low blood counts — have been reported and require prompt medical attention. Regular monitoring is key to catching problems early.

⚠️Warnings & precautions▾
  • High tyrosine levels: Nitisinone itself raises blood tyrosine. If tyrosine climbs above 500 micromol/L — often due to inadequate diet — it can cause corneal eye damage, intellectual disability, developmental delay, and painful skin thickening. Do not adjust your nitisinone dose to lower tyrosine; adjust your diet instead.
  • Eye monitoring: A slit-lamp eye exam is required before starting nitisinone and regularly throughout treatment. Report any eye pain, redness, or light sensitivity to your doctor immediately.
  • Low blood counts: Leukopenia (low white cells) and thrombocytopenia (low platelets) have occurred. Your doctor will monitor your blood counts regularly.
  • Liver complications in HT-1: Patients with HT-1 are already at risk for liver failure, liver tumors, and porphyric crises. These were observed even during treatment and require ongoing monitoring.
  • Glycerol in Orfadin oral suspension: High doses of the suspension may cause headache, stomach upset, or diarrhea due to glycerol content. Switching to Orfadin capsules may help.
🔀What it interacts with▾

Nitisinone affects certain drug-processing enzymes and transporters in the body, which can raise the blood levels of other medications you may be taking:

  • CYP2C9-metabolized drugs (such as warfarin, phenytoin, and celecoxib): nitisinone is a moderate inhibitor of this enzyme, so these drugs build up more in your system. Dose reductions and closer monitoring are typically needed.
  • OAT1/OAT3 substrate drugs (such as methotrexate, ganciclovir, and adefovir): nitisinone blocks these kidney transporters, raising blood levels of these drugs and increasing the risk of their side effects.
  • CYP2E1-metabolized drugs (such as chlorzoxazone): nitisinone weakly induces this enzyme, potentially lowering levels of drugs processed through it.

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: Animal studies showed potential harm to developing fetuses, including incomplete bone development and reduced pup survival. There is not enough human data to fully assess the risk. Discuss with your doctor before becoming pregnant.
  • Breastfeeding: It is not known whether nitisinone passes into human breast milk, but animal data suggest it may. Talk to your doctor about the risks and benefits before breastfeeding.
  • Children: Nitisinone is approved for pediatric patients with HT-1. Dosing is weight-based and requires careful monitoring.
  • Older adults (65+): There is limited data in elderly patients. Dose selection should be cautious, given the higher likelihood of reduced liver, kidney, or heart function in this age group.
  • Dietary commitment: You must maintain a strict low-tyrosine, low-phenylalanine diet throughout treatment. Failing to do so can lead to serious complications from high tyrosine levels.
  • No contraindications listed: The FDA label states there are no contraindications — but this does not mean nitisinone is right for everyone. Always inform your doctor of all your medical conditions and medications.
🚑If you take too much▾

If someone without a restricted diet accidentally takes nitisinone, their tyrosine levels can rise very high — in one study of healthy volunteers given a single dose, tyrosine peaked at around 1,200 micromol/L and remained elevated for weeks, though no serious changes in vital signs were reported. One person reported sensitivity to sunlight. If an overdose is suspected, seek medical attention right away.

📡Pharmacodynamics — effects in the body▾

Nitisinone works quickly to reduce the toxic byproducts of abnormal tyrosine metabolism. In clinical studies of HT-1 patients, urinary succinylacetone — the key toxic marker — normalized within a median of about 0.3 months, and plasma succinylacetone normalized in a median of about 3.9 months. Studies also showed that once succinylacetone levels are undetectable on twice-daily dosing, switching to the same total daily dose given once daily keeps levels suppressed.

🔬Pharmacokinetics — how your body processes it▾

Nitisinone is absorbed after oral dosing, with the oral suspension reaching peak blood levels faster than the capsule (about 3 hours earlier). It binds strongly to plasma proteins (more than 95%) and has a long half-life of about 54 hours, meaning it stays in the body for several days after a dose. It is broken down minimally by the liver (mainly via the CYP3A4 enzyme) and only a small fraction is eliminated unchanged through the kidneys, so renal elimination is minor. Steady-state blood levels are reached within about 14 days of once-daily dosing.

📦How to store it▾

Store refrigerated at 2° to 8°C (36° to 46°F). store ORFADIN capsules at room temperature up to 25°C (77°F) for up to 45 days. Store refrigerated at 2°C to 8°C (36°F to 46°F) prior to first use.

📄 Written from Nitisinone’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 →

21

Supplements & herbs that interact with Nitisinone

21 supplements and herbal products have documented interactions with Nitisinone 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 · 11
  • Minor · 9
ACTIVATED CHARCOAL Major CANNABINOL (CBN) Moderate CANNABIS Moderate COFFEE CHARCOAL Moderate DELTA-9-TETRAHYDROCANNABINOL (THC) Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate +13 more
Every supplement checked against Nitisinone — ranked by severity The full interaction hub: 1 major · 11 moderate · 9 minor · every one linked to its full report. Check Nitisinone 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 Nitisinone — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to follow a special diet while taking nitisinone? ▾
Nitisinone works by blocking a step in the breakdown of tyrosine — an amino acid found in many protein-rich foods. This means tyrosine can build up in your blood while you're on this medicine. If your tyrosine level gets too high, it can damage your eyes, slow development, and cause painful skin problems on your hands and feet. The diet — low in tyrosine and phenylalanine — is what keeps that from happening. The diet and the medication work together; you really need both.
What eye problems should I watch out for, and when should I call my doctor? ▾
High tyrosine levels can irritate and damage the surface of your eyes. Call your doctor right away if you notice eye pain, increased sensitivity to light, redness, swelling, or any change in your vision. Before you start nitisinone, you'll need a baseline eye exam (a slit-lamp exam), and your doctor will schedule regular check-ups throughout treatment. Don't wait for your next appointment if your eyes are bothering you.
Can I take my other medications while on nitisinone? ▾
Nitisinone can raise the blood levels of certain other drugs, which could make their effects — or side effects — stronger. This is especially important for blood thinners like warfarin, seizure medications like phenytoin, and some other drugs. Make sure your doctor and pharmacist know every medication you take, including over-the-counter drugs and supplements, so they can check for interactions and adjust doses if needed.
Is nitisinone safe to take during pregnancy or while breastfeeding? ▾
There isn't enough human data to say it's completely safe in pregnancy, and animal studies showed some concerning effects on fetal bone development. If you're pregnant, planning to become pregnant, or breastfeeding, have an honest conversation with your doctor about the risks and benefits. Nitisinone may pass into breast milk based on animal data, so your doctor will help you weigh what's right for your situation.
What blood tests will I need while I'm on this medication? ▾
Your doctor will monitor several things regularly: tyrosine levels in your blood, markers of liver health, alpha-fetoprotein (a liver tumor marker), and your blood cell counts — including white cells and platelets. For HT-1, succinylacetone in your blood or urine is also tracked closely, especially when you first start or when your dose changes. These tests help make sure the medicine is working and catch any problems early.
What should I do if I miss a dose? ▾
Just skip the missed dose and take your next one at your regular scheduled time. Do not take two doses at once to make up for the one you missed. If you're unsure what to do, call your pharmacist or prescriber — they can guide you based on your specific regimen.
Is Nitisinone available over the counter? ▾
Nitisinone 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 Nitisinone first available? ▾
Nitisinone has been available in the United States since at least 2002, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Nitisinone? ▾
Nitisinone is supplied by 17 manufacturers listed in the FDA NDC Directory, including Analog Pharma, Cycle Pharmaceuticals Ltd., Swedish Orphan Biovitrum Ab (publ).

💬 Answers drafted from Nitisinone’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

📊Nitisinone supplement interactions21 checked — ranked by severity 🌿Drug & Supplement CheckerNitisinone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Nitisinone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Nitisinone comes

Nitisinone is available in 3 forms. 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.

Capsule

By mouth
Brands Orfadin
How this form is used
What it may be used for
  • Orfadin capsules are used to treat hereditary tyrosinemia type 1 (HT-1) in adults and children, alongside a low-tyrosine, low-phenylalanine diet
  • Nitisinone capsules are used to treat hereditary tyrosinemia type 1 (HT-1) in adults and children, alongside a low-tyrosine, low-phenylalanine diet
Important instructions
  • Orfadin capsules should be taken at least one hour before or two hours after a meal
  • Orfadin capsules may be opened and mixed with a small amount of water, formula, or apple sauce immediately before use for patients who have difficulty swallowing and cannot tolerate the oral suspension
  • Nitisinone capsules should be taken at least one hour before or two hours after a meal
  • Nitisinone capsules may be opened and mixed with a small amount of water, formula, or apple sauce immediately before use for patients who have difficulty swallowing
Available strengths 4 strengths
2 mg 5 mg 10 mg 20 mg
38 FDA-listed product records ⓘ

Tablet

By mouth
Brands Harliku Nityr
How this form is used
What it may be used for
  • Nityr tablets are used to treat hereditary tyrosinemia type 1 (HT-1) in adults and children, alongside a low-tyrosine, low-phenylalanine diet
  • Harliku tablets are used in adults with alkaptonuria (AKU) to reduce levels of homogentisic acid (HGA) in the urine
Important instructions
  • Nityr tablets can be taken with or without food
  • Harliku tablets can be taken with or without food
  • If you miss a dose of Nityr or Harliku, skip the missed dose and take the next one at your scheduled time — do not double up
Available strengths 3 strengths
2 mg 5 mg 10 mg
13 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Orfadin
How this form is used
What it may be used for
  • Orfadin oral suspension is used to treat hereditary tyrosinemia type 1 (HT-1) in adults and children, alongside a low-tyrosine, low-phenylalanine diet
Important instructions
  • Orfadin oral suspension can be taken without regard to meals
  • Patients receiving more than 20 mL of Orfadin oral suspension in a single dose may experience headache, stomach upset, or diarrhea due to the glycerol content — talk to your doctor if this occurs
  • Follow your prescriber's instructions for preparing and measuring the correct dose of Orfadin oral suspension
Available strengths 1 strength
4 mg/mL
2 FDA-listed product records ⓘ

📊 Nitisinone across the U.S. market

How Nitisinone 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.

3
Dose forms ⓘ
17
Manufacturers
4
Brand names
60
FDA-listed product records ⓘ
2002
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Analog Pharma18%
Cycle Pharmaceuticals Ltd.17%
Swedish Orphan Biovitrum Ab (publ)10%
Bryant Ranch Prepack10%
Torrent pharmaceuticals limited7%
Eton Pharmaceuticals, Inc.7%
Other makers32%

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

📈 How widely Nitisinone is used

A general measure of how commonly Nitisinone 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 Nitisinone 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.

264
Medicaid prescriptions filled (Q1–Q4 2025)
$7.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nitisinone prescribed? Of the 1,597 medications we measure, Nitisinone ranks #1,435 by Medicaid prescriptions — more than 10% of them.

Where Nitisinone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,435 of 1,597
#1,430 Vonoprazan and Amoxici... 273 Rx #1,431 Elotuzumab Injection 269 Rx #1,432 Bexarotene 266 Rx #1,433 Dexrazoxane Injection 265 Rx #1,434 Sotorasib 265 Rx #1,435 Nitisinone 264 Rx #1,436 Caffeine 262 Rx #1,437 Dopamine 259 Rx #1,438 Nivolumab and relatlim... 245 Rx #1,439 Nefazodone 235 Rx #1,440 Mogamulizumab-kpkc Inj... 230 Rx

Utilization by Nitisinone 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 10 mg oral tablet is the most-dispensed Nitisinone product — about 33% of these Medicaid prescriptions.

nitisinone 10 MG Oral Tablet Most dispensed

88 Medicaid prescriptions (Q1–Q4 2025) 33% of Nitisinone prescriptions shown $4.5M gross reimbursement (before rebates) ≈ $50,695 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1941464

nitisinone 5 MG Oral Tablet

51 Medicaid prescriptions (Q1–Q4 2025) 19% of Nitisinone prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $20,891 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1941471

nitisinone 10 MG Oral Capsule

43 Medicaid prescriptions (Q1–Q4 2025) 16% of Nitisinone prescriptions shown $801,490 gross reimbursement (before rebates) ≈ $18,639 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351175

nitisinone 4 MG/ML Oral Suspension

39 Medicaid prescriptions (Q1–Q4 2025) 15% of Nitisinone prescriptions shown $768,308 gross reimbursement (before rebates) ≈ $19,700 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790310

nitisinone 2 MG Oral Tablet

31 Medicaid prescriptions (Q1–Q4 2025) 12% of Nitisinone prescriptions shown $184,604 gross reimbursement (before rebates) ≈ $5,955 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1941474

nitisinone 2 MG Oral Capsule

12 Medicaid prescriptions (Q1–Q4 2025) 5% of Nitisinone prescriptions shown $17,668 gross reimbursement (before rebates) ≈ $1,472 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351173

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 Nitisinone, 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 6 of 15 listed Nitisinone NDCs with Medicaid activity.

🔍 Compare Nitisinone products

A representative set of FDA-listed product records for Nitisinone — 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 60 of 60 products — FDA National Drug Code Directory. See every product, package size and price: browse all 60 Nitisinone 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) Nitisinone RxCUI 61805 3 dose forms · 8 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 378717 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 351173 5 MG RxCUI 351174 10 MG RxCUI 351175 20 MG RxCUI 1798999
  2. Dose form (SCDF) Oral Suspension RxCUI 1790308 In current FDA listings
    Clinical drug / strength (SCD) 4 MG/ML RxCUI 1790310
  3. Dose form (SCDF) Oral Tablet RxCUI 1941463 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 1941474 5 MG RxCUI 1941471 10 MG RxCUI 1941464

Look up RxCUI 61805 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

Orfadin Nityr Harliku

🏭 Manufacturers & labelers

Analog Pharma 11 Cycle Pharmaceuticals Ltd. 10 Swedish Orphan Biovitrum Ab (publ) 6 Bryant Ranch Prepack 6 Torrent pharmaceuticals limited 4 Eton Pharmaceuticals, Inc. 4 Endo USA, Inc. 3 Par Health USA, LLC 3 Par Pharmaceutical, Inc. 3 Penn Pharmaceutical Services Ltd 3 Cohance Lifesciences Limited 1 Bachem AG 1 Nuray Chemicals Private Limited 1 SCL Lifesciences Limited 1 Sionc Pharmaceutical Private Limited 1 Anthem Biosciences Limited 1 Amino Chemicals Ltd 1

RxNorm drug class

Nitisinone belongs to the 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor class.

Pharmacologic class 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Drug family (ATC) Various alimentary tract and metabolism products
How it works Hydroxyphenylpyruvate Dioxygenase Inhibitors, Cytochrome P450 2C9 Inhibitors, Organic Anion Transporter 1 Inhibitors, Organic Anion Transporter 3 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 Dec 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nitisinone.
📈
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 Nitisinone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
NDC products indexed
60
Distinct labelers/manufacturers represented
17
Linked representative label ⓘ
Cycle Pharmaceuticals Ltd.
Linked label effective
Dec 22, 2025
Composite sections available
21
Linked SPL Set ID
00fd1905-27e4-420e-8dc5-a69e4ddc1526
Linked SPL Document ID
9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92
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. Cycle Pharmaceuticals Ltd. 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.