Prescription medicine
Gefitinib Brand names: Iressa
Gefitinib (Iressa) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
Check it at the source: the gefitinib FDA label on DailyMed (effective February 28, 2023, AstraZeneca Pharmaceuticals LP); the NDA 21399 record on Drugs@FDA; every gefitinib label on DailyMed.
Highlights of the record
FDA label of February 28, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ].
Forms and strengths
- 250 mg
Coated tablet; film-coated tablet.
On the market
- Earliest approval on file
- May 5, 2003 Iressa, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first September 23, 2022; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
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
- 8,974 through July 30, 2026
What is gefitinib used for?
From the label: indications and usageIRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ]. Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ]. […]
Conditions named in the indications of gefitinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (IRESSA), AstraZeneca Pharmaceuticals LP, effective February 28, 2023 (SPL set 827d60e8-7e07-41b7-c28b-49ef1c4a5a41), via openFDA; the full label on DailyMed
Is there a generic for gefitinib (Iressa)?
The FDA approved the first generic gefitinib on September 23, 2022. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists gefitinib from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2022 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gefitinib label say about other medicines?
The gefitinib label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name gefitinib. 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 |
|---|---|---|
| Itraconazole | drug interactions | CYP3A4 Inhibitor Drugs that are strong inhibitors of CYP3A4 (e.g., ketoconazole and itraconazole) decrease gefitinib metabolism and increase gefitinib plasma concentrations. |
| Ketoconazole | drug interactions | CYP3A4 Inhibitor Drugs that are strong inhibitors of CYP3A4 (e.g., ketoconazole and itraconazole) decrease gefitinib metabolism and increase gefitinib plasma concentrations. |
| Phenytoin | drug interactions | Increase IRESSA to 500 mg daily in patients receiving a strong CYP3A4 inducer (e.g., rifampicin, phenytoin, or tricyclic antidepressant) and resume IRESSA at 250 mg 7 days after discontinuation of the strong inducer [see Dosage and Administration (2.4), Clinical Pharmacology (12.3) ]. |
| Warfarin | drug interactions | Hemorrhage in patients taking warfarin: Monitor changes in prothrombin time or INR. |
Source: FDA drug label (IRESSA), AstraZeneca Pharmaceuticals LP, effective February 28, 2023 (SPL set 827d60e8-7e07-41b7-c28b-49ef1c4a5a41), via openFDA; the full label on DailyMed
What do FAERS reports show for gefitinib?
The FDA Adverse Event Reporting System holds 8,974 reports that list gefitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,952 are coded as a death and 2,577 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 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 gefitinib?
26 other medicines are given the same way (oral) and in the same FDA class as gefitinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. 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 |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
| Trametinib | Lung cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to gefitinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Gefitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other