Prescription medicine
Erlotinib First approved as Tarceva
Erlotinib (Tarceva) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 10 generic labelers.
- Generic listed
Check it at the source: the erlotinib FDA label on DailyMed (effective June 10, 2024, Alembic Pharmaceuticals Limited); the NDA 21743 record on Drugs@FDA; every erlotinib label on DailyMed.
Highlights of the record
FDA label of June 10, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageErlotinib tablets are a kinase inhibitor indicated for: The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy re
Forms and strengths
- 25 mg
- 100 mg
- 150 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- November 18, 2004 Tarceva, Osi Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first June 11, 2014; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 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
- 12,438 through July 30, 2026
What is erlotinib used for?
From the label: indications and usageErlotinib tablets are a kinase inhibitor indicated for: The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1) First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. […]
Conditions named in the indications of erlotinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (ERLOTINIB HYDROCHLORIDE), Alembic Pharmaceuticals Limited, effective June 10, 2024 (SPL set ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b), via openFDA; the full label on DailyMed
Is there a generic for erlotinib (Tarceva)?
The FDA approved the first generic erlotinib on June 11, 2014. 13 generic applications are approved; 8 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 erlotinib from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2014 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the erlotinib label say about other medicines?
The erlotinib label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name erlotinib. 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 |
|---|---|---|
| Carbamazepine | drug interactions | Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St. John's wort) is unavoidable [see Dosage and Administration (2.4)]. |
| Ciprofloxacin | drug interactions | … telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and CYP1A2 inhibitor (e.g., ciprofloxacin). |
| Clarithromycin | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Gemcitabine | warnings and precautions | In comparison, in the placebo/gemcitabine group there were no cerebrovascular accidents. |
| Itraconazole | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Ketoconazole | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Lopinavir and ritonavir | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Nefazodone | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Nelfinavir | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Omeprazole | drug interactions | Drugs the Increase Gastric pH Co-administration of erlotinib with proton pump inhibitors (e.g., omeprazole) and H-2 receptor antagonists (e.g., ranitidine) decreased erlotinib exposure [see Clinical Pharmacology (12.3)]. |
| Phenobarbital | drug interactions | Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St. John's wort) is unavoidable [see Dosage and Administration (2.4)]. |
| Phenytoin | drug interactions | Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St. John's wort) is unavoidable [see Dosage and Administration (2.4)]. |
| Posaconazole | drug interactions | Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and … |
| Ranitidine | drug interactions | Drugs the Increase Gastric pH Co-administration of erlotinib with proton pump inhibitors (e.g., omeprazole) and H-2 receptor antagonists (e.g., ranitidine) decreased erlotinib exposure [see Clinical Pharmacology (12.3)]. |
Every other medicine the erlotinib label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifabutin | drug interactions | Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St. … |
| Rifampin | drug interactions | Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St. … |
| Rifapentine | drug interactions | Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St. … |
| Ritonavir | drug interactions | … clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or … |
| Teriflunomide | drug interactions | Avoid smoking tobacco (CYP1A2 inducer) and avoid concomitant use of erlotinib with moderate CYP1A2 inducers (e.g., teriflunomide, rifampin, or phenytoin). |
| Voriconazole | drug interactions | … nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and CYP1A2 inhibitor (e.g., ciprofloxacin). |
| Warfarin | drug interactions | Anticoagulants Interaction with coumarin-derived anticoagulants, including warfarin, leading to increased International Normalized Ratio (INR) and bleeding adverse reactions, which in some cases were … |
Other labels that name erlotinib
Source: FDA drug label (ERLOTINIB HYDROCHLORIDE), Alembic Pharmaceuticals Limited, effective June 10, 2024 (SPL set ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b), via openFDA; the full label on DailyMed
What do FAERS reports show for erlotinib?
The FDA Adverse Event Reporting System holds 12,438 reports that list erlotinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,765 are coded as a death and 3,881 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 erlotinib?
26 other medicines are given the same way (oral) and in the same FDA class as erlotinib 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 |
|---|---|---|---|---|
| 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 |
| Gefitinib | Lung cancer | 4 labelers | 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 erlotinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Erlotinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other