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Prescription medicine

Pembrolizumab

Brand names: Keytruda

Drug class: Programmed Death Receptor-1 Blocking Antibody

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2014First FDA approval on file

Quick answers

What is Pembrolizumab used for?
The FDA-approved label (Keytruda, Merck Sharp & Dohme LLC, July 10, 2026) says: “KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Pembrolizumab have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Pembrolizumab?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Pembrolizumab been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Pembrolizumab?
1 company lists prescription products of Pembrolizumab in the FDA NDC Directory, including Merck Sharp & Dohme LLC.

What Pembrolizumab is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. …

— FDA label: Keytruda, Merck Sharp & Dohme LLC, effective July 10, 2026. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Breast cancerLung cancerColorectal cancerOvarian cancerCervical cancerEndometrial CancerKidney cancerHodgkin Lymphoma

Related medical specialties

Oncology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteIntravenous
Prescription products1 in the FDA NDC Directory
Brand namesKeytruda

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA125514
KEYTRUDA		 Merck Sharp DohmeSeptember 4, 2014 127, latest October 16, 2026
2026: Efficacy · 2026: Efficacy · 2026: Efficacy

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1657746, 1657749, 1657750, 1657751
SPL set ID of the quoted label9333c79b-d487-4538-a9f0-71b91a02b287
FDA labels (SPL)1
FDA applicationsBLA125514
Active ingredients (FDA)PEMBROLIZUMAB

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Keytruda, Merck Sharp & Dohme LLC, effective July 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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