Prescription medicine
Trastuzumab Brand names: Ogivri, Kanjinti, Herzuma, Trazimera, Ontruzant
Trastuzumab (Herceptin) is a prescription medicine with an FDA approval on record since 1998. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the trastuzumab FDA label on DailyMed (effective May 29, 2026, Genentech, Inc.); the BLA 103792 record on Drugs@FDA; every trastuzumab label on DailyMed.
Highlights of the record
FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY,.
and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Herceptin can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Herceptin for cardiomyopathy. ( 2.5 , 5.1 ) Infusion Reactions, Pulmonary Toxicity: Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. ( 5.2 , 5.4 ) Embryo-Fetal Toxicity: Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. ( 5.3 , 8.1 , 8.3 ) Cardiomyopathy Herceptin administration can result in sub - clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline - containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. […]
Used for
From the label: indications and usageHerceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer.
Forms and strengths
- 150 mg
- 150 mg/7.15ml
- 150 mg/7.4ml
- 420 mg/20ml
Injection (powder) (lyophilized) for solution; kit.
On the market
- Earliest approval on file
- September 25, 1998 Herceptin, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 7 of which 0 under generic applications, 7 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)
- 0 since 2019 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 70,268 through July 30, 2026
What is trastuzumab used for?
From the label: indications and usageHerceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. […]
Conditions named in the indications of trastuzumab's FDA labels, with every medicine labeled for each:
From other trastuzumab labelsBreast cancer: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens …
FDA pharmacologic class: HER2/neu Receptor Antagonist.
Source: FDA drug label (Herceptin), Genentech, Inc., effective May 29, 2026 (SPL set 492dbdb2-077e-4064-bff3-372d6af0a7a2), via openFDA; the full label on DailyMed
Is there a generic for trastuzumab (Herceptin)?
No generic trastuzumab is approved (Drugs@FDA, October 8, 2026).
- 1998 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has trastuzumab been recalled?
The FDA's Enforcement Report lists 1 recall naming trastuzumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of trastuzumab and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the trastuzumab label say about other medicines?
The trastuzumab label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name trastuzumab. 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 |
|---|---|---|
| Cyclophosphamide | warnings and precautions | NSABP B31 & NCCTG N9831 Median follow-up duration for NSABP B31 & NCCTG N9831 combined was 8.3 years in the AC→paclitaxel+Herceptin arm.; AC Anthracycline (doxorubicin) and cyclophosphamide. →Paclitaxel+Herceptin; … |
| Diphenhydramine | warnings and precautions | Interrupt Herceptin infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). |
| Doxorubicin | warnings and precautions | NSABP B31 & NCCTG N9831 Median follow-up duration for NSABP B31 & NCCTG N9831 combined was 8.3 years in the AC→paclitaxel+Herceptin arm.; AC Anthracycline (doxorubicin) and cyclophosphamide. →Paclitaxel+Herceptin; … |
| Epinephrine | warnings and precautions | Interrupt Herceptin infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). |
| Epirubicin | warnings and precautions | H0648g (AC) Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.; Cardiac Dysfunction; 28%; 7%; 19%; 3% |
| Paclitaxel | warnings and precautions | NSABP B31 & NCCTG N9831 Median follow-up duration for NSABP B31 & NCCTG N9831 combined was 8.3 years in the AC→paclitaxel+Herceptin arm.; AC Anthracycline (doxorubicin) and cyclophosphamide. →Paclitaxel+Herceptin; … |
Other labels that name trastuzumab
Source: FDA drug label (Herceptin), Genentech, Inc., effective May 29, 2026 (SPL set 492dbdb2-077e-4064-bff3-372d6af0a7a2), via openFDA; the full label on DailyMed
What do FAERS reports show for trastuzumab?
The FDA Adverse Event Reporting System holds 70,268 reports that list trastuzumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8,319 are coded as a death and 20,178 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 trastuzumab?
12 other medicines are given the same way (intravenous) and in the same FDA class as trastuzumab or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 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 (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
| Pertuzumab | Breast cancer | none listed | n/a | No current entry |
| Docetaxel | Breast cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer | 10 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as trastuzumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trastuzumab
- 12 medicines for the same use
- Other her2/neu receptor antagonists
- the pharmacologic class, with prices and generics
- Trastuzumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other