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Trastuzumab: uses, dosing, side effects & brands

Trastuzumab is a her2/neu receptor antagonist sold in the U.S. under one brand, for breast neoplasms, gastrointestinal neoplasms and stomach neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Her2/Neu Receptor Antagonist
Treats
Breast Neoplasms, Gastrointestinal Neoplasms and Stomach Neoplasms
Available as
Injectable
Sold as
Herceptin
Prescription?
Prescription only
Generic available?
Not in our catalog
Boxed warning
Boxed warning

How trastuzumab is dosed

From the FDA label for Herceptin (application BLA103792). Other trastuzumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

For intravenous (IV) infusion only. Do not administer as an IV push or bolus. Herceptin has different dosage and administration instructions than subcutaneous trastuzumab products. ( 2.3 ) Do not substitute Herceptin (trastuzumab) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. ( 2.3 ) Perform HER2 testing using FDA-authorized tests by laboratories with demonstrated proficiency. ( 1 , 2.2 ) Adjuvant Treatment of HER2-Overexpressing Breast Cancer ( 2.2 ) Administer at either: Initial dose of 4 mg/kg over 90 minutes IV infusion, then 2 mg/kg over 30 minutes IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of Herceptin, administer 6 mg/kg as an IV infusion over 30–90 minutes every three weeks to complete a total of 52 weeks of therapy, or Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30–90 minutes IV infusion every three weeks for 52 weeks. Metastatic HER2-Overexpressing Breast Cancer ( 2.3 ) Initial dose of 4 mg/kg as a 90 minutes IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minutes IV infusions. Metastatic HER2-Overexpressing Gastric Cancer ( 2.3 ) Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks. 2.1 Evaluation and Testing Before Initiating…

Trastuzumab side effects

The following adverse reactions are discussed in greater detail in other sections of the label: Cardiomyopathy [see Warnings and Precautions (5.1) ] Infusion Reactions [see Warnings and Precautions (5.2) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Exacerbation of Chemotherapy-Induced Neutropenia [see Warnings and Precautions (5.5) ] Adjuvant Breast Cancer Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills. ( 6.1 ) Metastatic Breast Cancer Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. ( 6.1 ) Metastatic Gastric Cancer Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions in…

Who shouldn’t take trastuzumab

None. None. ( 4 )

Trastuzumab drug interactions

Anthracyclines Patients who receive anthracycline after stopping Herceptin may be at increased risk of cardiac dysfunction because of trastuzumab's estimated long washout period [see Clinical Pharmacology (12.3) ] . If possible, avoid anthracycline-based therapy for up to 7 months after stopping Herceptin. If anthracyclines are used, closely monitor the patient's cardiac function.

Every trastuzumab product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Herceptin.

Combination products containing trastuzumab

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

How long trastuzumab keeps

The date on a sealed pack is not the only one: some trastuzumab labels start a second clock once the product is opened or mixed, as short as 24 hours.

Does trastuzumab expire? The in-use limits and storage rules from its labels

Trastuzumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Trastuzumab milk concentrations were collected in one mother. Concentrations were low, consistent with it being a large protein molecule with a molecular weight of about of 145,531 Da. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, trastuzumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during trastuzumab therapy and for 7 months after the last dose.

Full LactMed record for trastuzumab: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised June 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about trastuzumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 36,591 reports naming trastuzumab, and the FDA flagged 95% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • diarrhoea3,821 reports
  • nausea2,842 reports
  • fatigue2,497 reports
  • myelosuppression2,211 reports
  • vomiting1,867 reports
  • neutropenia1,690 reports
  • dyspnoea1,538 reports
  • pyrexia1,486 reports

Read these as a signal, not a rate. A report does not mean trastuzumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 26, 2026.

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Frequently asked questions

What is trastuzumab?

Herceptin (Trastuzumab) is a HER2/neu receptor antagonist used to treat Breast Neoplasms, Gastrointestinal Neoplasms, Stomach Neoplasms.

What kind of drug is trastuzumab?

The FDA classifies trastuzumab as a her2/neu receptor antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take trastuzumab with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run trastuzumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does trastuzumab come in?

Across the brands we track, trastuzumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic trastuzumab?

We do not currently list a generic-labelled trastuzumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Trastuzumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/trastuzumab
MLA
“Trastuzumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/trastuzumab.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for trastuzumab on DailyMed (NIH) ↗ — including its boxed warning in full.