Prescription medicine
Fruquintinib Brand names: Fruzaqla
Fruquintinib (Fruzaqla) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the fruquintinib FDA label on DailyMed (effective July 31, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 217564 record on Drugs@FDA; every fruquintinib label on DailyMed.
Highlights of the record
FDA label of July 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
Forms and strengths
- 1 mg
- 5 mg
Capsule.
On the market
- Earliest approval on file
- November 8, 2023 Fruzaqla, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 7, 2035 Fruzaqla capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,770 through July 30, 2026
What is fruquintinib used for?
From the label: indications and usageINDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
Conditions named in the indications of fruquintinib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Fruzaqla), Takeda Pharmaceuticals America, Inc., effective July 31, 2026 (SPL set 186d786e-dc8a-45f2-b5e1-01ac0201879f), via openFDA; the full label on DailyMed
Is there a generic for fruquintinib (Fruzaqla)?
No generic fruquintinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Fruzaqla capsules: the compound patent runs to September 7, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fruquintinib label say about other medicines?
The fruquintinib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. |
Source: FDA drug label (Fruzaqla), Takeda Pharmaceuticals America, Inc., effective July 31, 2026 (SPL set 186d786e-dc8a-45f2-b5e1-01ac0201879f), via openFDA; the full label on DailyMed
What do FAERS reports show for fruquintinib?
The FDA Adverse Event Reporting System holds 3,770 reports that list fruquintinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,245 are coded as a death and 1,141 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,820, against a median of 6 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fruquintinib?
4 other medicines are given the same way (oral) and in the same FDA class as fruquintinib or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Capecitabine | Colorectal cancer | 18 labelers | $0.456 per tablet 500 mg tablet | No current entry |
| Tipiracil and trifluridine | Colorectal cancer | none listed | n/a | No current entry |
| Encorafenib | Colorectal cancer | none listed | n/a | No current entry |
| Regorafenib | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as fruquintinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fruquintinib
- 4 medicines for the same use
- Fruquintinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other