FDA-filed SPL labeling · retrieved through openFDA

Fruquintinib

Fruquintinib is a targeted cancer therapy used to treat metastatic colorectal cancer in adults who have already received multiple prior treatments.

Brand name Fruzaqla
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 13, 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 1 clinical label set 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 effectiveJul 31, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2023
FDA-listed product records ⓘ12
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Fruquintinib at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fruquintinib (Fruzaqla) is a targeted oral therapy for adults with heavily pre-treated metastatic colorectal cancer — it works by cutting off the blood supply tumors need to grow. It requires close monitoring for high blood pressure, bleeding, liver changes, and other significant risks throughout treatment. Anyone who is pregnant or could become pregnant must use effective contraception, as this drug can cause serious harm to a developing baby.

📖 Fruquintinib: Patient Information Guide

A plain-language walkthrough of Fruquintinib — 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▾

Fruquintinib is a targeted therapy approved for adults with advanced colorectal cancer that has spread beyond the colon or rectum.

  • Fruzaqla (fruquintinib capsules, taken by mouth) is indicated for adults with metastatic colorectal cancer (mCRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and — if their tumor is RAS wild-type and it is medically appropriate — an anti-EGFR therapy.
⚙️How it works▾

Fruquintinib is a kinase inhibitor that targets VEGF receptors (VEGFR-1, -2, and -3) — proteins found on the surface of blood vessel cells. Tumors send out signals that activate these receptors to spur the growth of new blood vessels, a process called angiogenesis, which feeds the tumor oxygen and nutrients. Fruquintinib blocks all three VEGFR subtypes, shutting down this signaling and starving the tumor of the blood supply it needs to grow. Lab and animal studies have shown it can inhibit tumor blood vessel formation and slow tumor growth in colon cancer models.

💊How it's taken▾

Fruzaqla is taken as an oral capsule once a day, on a 3-weeks-on, 1-week-off cycle: you take it for the first 21 days of a 28-day cycle, then pause for 7 days before starting the next cycle. It can be taken with or without food, and you should try to take it at the same time each day.

  • Swallow the capsule whole — do not crush, chew, or open it.
  • If you miss a dose and fewer than 12 hours have passed, take it. If more time has passed, skip that dose — never take two doses in one day to make up for a missed one.
  • If you vomit after taking a dose, do not take another — just continue with your next scheduled dose.
🤒Side effects — in detail▾

The most common side effects people experience with Fruzaqla include:

  • High blood pressure
  • Hand-foot skin reactions (palmar-plantar erythrodysesthesia) — redness, pain, swelling, or peeling on the palms and soles
  • Protein in the urine (proteinuria)
  • Voice hoarseness or changes (dysphonia)
  • Abdominal pain
  • Diarrhea
  • Fatigue or weakness (asthenia)
  • Mouth sores (stomatitis)
  • Hypothyroidism (underactive thyroid)

More serious reactions — including severe bleeding, gut perforation, liver injury, serious infections, and a rare brain swelling condition (PRES) — require prompt medical attention if signs appear.

⚠️Warnings & precautions▾
  • High blood pressure: Nearly half of patients develop it, including severe cases. Blood pressure must be controlled before starting and monitored weekly for the first month, then monthly. Medication adjustments or dose changes may be needed.
  • Bleeding: Serious and sometimes fatal bleeding events have occurred, including gastrointestinal bleeding. Risk should be assessed and INR monitored in patients on blood thinners.
  • Infections: Fruzaqla raises the risk of infections, including fatal ones. Do not start treatment during an active infection. Report any fever, chills, or worsening symptoms promptly.
  • GI perforation: A hole can develop in the stomach or intestines — a medical emergency. Fruzaqla must be permanently stopped if this occurs.
  • Liver injury (hepatotoxicity): Liver enzyme elevations are common; severe cases have occurred. Liver tests are checked before and during treatment.
  • Proteinuria: Significant protein in the urine occurred in over a third of patients. Kidney function is monitored throughout therapy.
  • Wound healing: Fruzaqla must be paused at least 2 weeks before and 2 weeks after major surgery.
  • Embryo-fetal toxicity: This drug can seriously harm a developing baby. Effective contraception is required during treatment and for 2 weeks after the last dose.
  • PRES (posterior reversible encephalopathy syndrome): A rare brain condition causing seizures, headache, vision changes, or confusion — seek emergency care immediately if these occur.
  • Arterial blood clots: Fruzaqla may increase the risk of arterial thromboembolism (blood clots in arteries). It should be used cautiously in patients with a recent history of clotting events.
🔀What it interacts with▾

Fruquintinib is broken down mainly by liver enzymes, so drugs that affect those enzymes can change how much fruquintinib is in your system:

  • Strong CYP3A inducers (e.g., rifampin, a common antibiotic for tuberculosis): Significantly reduce fruquintinib blood levels, which could make it less effective. Avoid combining these.
  • Moderate CYP3A inducers (e.g., efavirenz, used for HIV): Can also reduce fruquintinib levels. Avoid if possible; if unavoidable, your doctor will advise on dosing.
  • Anticoagulants (blood thinners): Fruzaqla carries a bleeding risk, and INR levels should be monitored more closely in patients on anticoagulants.

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: Fruquintinib can cause serious harm or loss of a pregnancy. Tell your doctor immediately if you are pregnant or think you might be.
  • Contraception: Females who can become pregnant and males with female partners who can become pregnant must use effective contraception during treatment and for 2 weeks after the last dose.
  • Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose due to potential risk to the infant.
  • Fertility: Animal studies suggest fruquintinib may affect female fertility. Discuss family planning with your doctor before starting.
  • Children: Safety and effectiveness have not been established in patients under 18 years of age.
  • Older adults: Patients 65 and older have been studied and no overall differences in safety or effectiveness were observed compared to younger patients.
  • Liver impairment: Fruzaqla is not recommended for patients with severe liver impairment. Use in moderate liver impairment has not been sufficiently studied.
  • Uncontrolled high blood pressure: Blood pressure must be adequately controlled before starting Fruzaqla.
  • Recent blood clots or cardiovascular disease: Patients with a recent history of arterial clotting events or significant heart disease were excluded from clinical trials — discuss your history with your doctor.
  • Dye allergy: The 1 mg capsule contains yellow dye additives (FD&C Yellow No. 5 and No. 6) that can cause allergic reactions, including in people with aspirin sensitivity or asthma. Tell your doctor if you have these allergies.
📡Pharmacodynamics — effects in the body▾

Fruquintinib blocks VEGF receptor signaling, which stops tumor blood vessel formation. At the approved dose, it does not appear to significantly prolong the QTc interval (the heart's electrical recovery time), which is reassuring for heart rhythm safety. The full relationship between fruquintinib blood levels and clinical response has not been fully characterized.

🔬Pharmacokinetics — how your body processes it▾

After taking Fruzaqla by mouth, fruquintinib reaches peak blood levels in about 2 hours, and food does not meaningfully affect absorption — so it can be taken with or without a meal. It binds strongly to blood proteins (about 95%) and has a half-life of roughly 42 hours, meaning it stays in the body for a day and a half after each dose. Steady, stable drug levels build up over about 14 days of daily dosing. The drug is broken down mainly by liver enzymes (primarily CYP3A) and excreted mostly through urine, with a smaller portion in stool.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F).

📄 Written from Fruquintinib’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 →

168

Supplements & herbs that interact with Fruquintinib

168 supplements and herbal products have documented interactions with Fruquintinib 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 · 6
  • Moderate · 124
  • Minor · 38
Every supplement checked against Fruquintinib — ranked by severity The full interaction hub: 6 major · 124 moderate · 38 minor · every one linked to its full report. Check Fruquintinib 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 Fruquintinib — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Fruzaqla and why was it prescribed to me? ▾
Fruzaqla contains the active ingredient fruquintinib, and it's designed specifically for adults whose colorectal cancer has spread and who have already tried several rounds of standard chemotherapy and other targeted treatments. It works by blocking the signals tumors use to build new blood vessels — essentially cutting off the tumor's food supply. Your oncologist prescribed it because you've already been through earlier lines of treatment and this is a next option to help slow the cancer's growth.
How do I take it, and does it matter if I take it with food? ▾
You take one capsule by mouth once a day — swallowed whole — for the first 21 days of every 28-day cycle. Then you take 7 days off before the next cycle starts. The good news is food doesn't affect how the medicine works, so you can take it with or without a meal — whatever is most comfortable for you. Try to take it at the same time each day to keep levels consistent. If you miss a dose, only take it if fewer than 12 hours have passed since you were supposed to take it. Otherwise, just skip it and get back on track with the next dose.
What side effects should I expect, and which ones should make me call my doctor right away? ▾
The most common things people notice are high blood pressure, soreness or peeling on the palms and soles of the feet (called hand-foot skin reactions), fatigue, diarrhea, and a hoarse or changed voice. These are worth telling your doctor about, but they're manageable. What you should call about right away — don't wait — are signs of severe high blood pressure like a sudden bad headache or blurred vision, any unusual bleeding, a sudden severe stomach pain, fever or signs of infection, or anything like seizures, confusion, or vision changes. These need prompt medical attention.
I take other medications. Are there any I should be worried about? ▾
Yes, a few interactions are worth flagging. Certain drugs that 'speed up' liver enzymes — called CYP3A inducers — can lower fruquintinib levels in your blood and make it less effective. A common example is rifampin, used for tuberculosis. If you're on any HIV medications, anti-seizure drugs, or other long-term prescriptions, bring a full list to your oncologist and pharmacist. Also, if you take blood thinners, your INR (a clotting measure) will need to be checked more frequently since Fruzaqla carries a bleeding risk.
Can I get pregnant while taking this, or do I need to worry about birth control? ▾
This is a really important one. Fruquintinib has been shown to cause serious harm to a developing baby — including birth defects and pregnancy loss — in animal studies. If you can become pregnant, you must use effective contraception while taking Fruzaqla and for 2 weeks after your last dose. The same applies if you're a male whose partner could become pregnant. You should also not breastfeed during treatment or for 2 weeks after stopping. If there's any chance you're pregnant, tell your care team immediately before starting.
I have a surgery coming up. Do I need to stop Fruzaqla before it? ▾
Yes, and this is important to plan ahead for. Drugs that block VEGF signaling — like fruquintinib — can interfere with how well wounds heal. Your doctor will need to pause Fruzaqla at least 2 weeks before any major surgery. You also shouldn't restart it for at least 2 weeks after surgery and only once your wounds have healed well. Make sure your surgeon and oncologist are in communication about the timing so nothing gets missed.
Is Fruquintinib available over the counter? ▾
Fruquintinib 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 Fruquintinib first available? ▾
Fruquintinib has been available in the United States since at least 2023, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fruquintinib? ▾
Fruquintinib is supplied by 2 manufacturers listed in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc., HUTCHMED International Corporation.

💬 Answers drafted from Fruquintinib’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

💊 How Fruquintinib comes

Fruquintinib 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.

Capsule

By mouth
Brands Fruzaqla
How this form is used
What it may be used for
  • Fruzaqla capsules are used to treat adults with metastatic colorectal cancer who have already received multiple standard therapies
Important instructions
  • Fruzaqla capsules are taken once daily by mouth for the first 21 days of each 28-day cycle
  • Fruzaqla capsules can be taken with or without food — swallow whole, do not crush or chew
  • Take Fruzaqla at approximately the same time each day
  • If you vomit after taking Fruzaqla, do not take an extra dose — continue with your next scheduled dose
Available strengths 2 strengths
12 FDA-listed product records ⓘ

📊 Fruquintinib across the U.S. market

How Fruquintinib 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 ⓘ
2
Manufacturers
1
Brand names
12
FDA-listed product records ⓘ
2023
First marketed ⓘ
Takeda Pharmaceuticals America, Inc.67%
HUTCHMED International Corporation33%

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

📈 How widely Fruquintinib is used

A general measure of how commonly Fruquintinib 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 Fruquintinib 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.

323
Medicaid prescriptions filled (Q1–Q4 2025)
$8.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fruquintinib prescribed? Of the 1,597 medications we measure, Fruquintinib ranks #1,412 by Medicaid prescriptions — more than 12% of them.

Where Fruquintinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Fruquintinib 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 oral capsule is the most-dispensed Fruquintinib product — about 97% of these Medicaid prescriptions.

fruquintinib 5 MG Oral Capsule Most dispensed

312 Medicaid prescriptions (Q1–Q4 2025) 97% of Fruquintinib prescriptions shown $8.1M gross reimbursement (before rebates) ≈ $25,983 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2670196

fruquintinib 1 MG Oral Capsule

11 Medicaid prescriptions (Q1–Q4 2025) 3% of Fruquintinib prescriptions shown $283,407 gross reimbursement (before rebates) ≈ $25,764 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2670184

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 Fruquintinib, 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 2 of 6 listed Fruquintinib NDCs with Medicaid activity.

🔍 Compare Fruquintinib products

A representative set of FDA-listed product records for Fruquintinib — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
1 mg — HUTCHMED International Corporation × 2 listings DRUG FOR FURTHER PROCESSING View NDC →
5 mg — HUTCHMED International Corporation × 2 listings DRUG FOR FURTHER PROCESSING View NDC →
1 mg Oral Takeda Pharmaceuticals America, Inc. × 4 listings NDA View NDC →
5 mg Oral Takeda Pharmaceuticals America, Inc. × 4 listings NDA View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Fruquintinib 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) Fruquintinib RxCUI 2670179 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 2670183 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 2670184 5 MG RxCUI 2670196

Look up RxCUI 2670179 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

Fruzaqla

🏭 Manufacturers & labelers

Takeda Pharmaceuticals America, Inc. 8 HUTCHMED International Corporation 4

RxNorm drug class

Fruquintinib belongs to the Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors class.

Drug family (ATC) Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase 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 Jul 31, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fruquintinib.
📈
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 Fruquintinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
12
Distinct labelers/manufacturers represented
2
Linked representative label ⓘ
Takeda Pharmaceuticals America, Inc.
Linked label effective
Jul 31, 2026
Composite sections available
21
Linked SPL Set ID
186d786e-dc8a-45f2-b5e1-01ac0201879f
Linked SPL Document ID
8e86a087-ef8d-424c-8cfe-208bf8d4e122
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 1 FDA-filed SPL label set 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. Takeda Pharmaceuticals America, 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.