Prescription medicine
Pembrolizumab Brand names: Keytruda
Pembrolizumab (Keytruda) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pembrolizumab FDA label on DailyMed (effective July 10, 2026, Merck Sharp & Dohme LLC); the BLA 125514 record on Drugs@FDA; every pembrolizumab label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma.
Forms and strengths
- 25 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- September 4, 2014 Keytruda, Merck Sharp Dohme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 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)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 104,596 through July 30, 2026
What is pembrolizumab used for?
From the label: indications and usageKEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. […]
Conditions named in the indications of pembrolizumab's FDA labels, with every medicine labeled for each:
From other pembrolizumab labelsColorectal cancer: … options. ( 1.8 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an …
Leukemia, lymphoma and myeloma: Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
Breast cancer: Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single …
FDA pharmacologic class: Programmed Death Receptor-1 Blocking Antibody.
Source: FDA drug label (KEYTRUDA), Merck Sharp & Dohme LLC, effective July 10, 2026 (SPL set 9333c79b-d487-4538-a9f0-71b91a02b287), via openFDA; the full label on DailyMed
What does the patient leaflet for pembrolizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KEYTRUDA?KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath, swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. […]
Source: FDA drug label (KEYTRUDA), Merck Sharp & Dohme LLC, effective July 10, 2026 (SPL set 9333c79b-d487-4538-a9f0-71b91a02b287), via openFDA; the full label on DailyMed
Is there a generic for pembrolizumab (Keytruda)?
No generic pembrolizumab is approved (Drugs@FDA, October 8, 2026).
- 2014 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has pembrolizumab been recalled?
The FDA's Enforcement Report lists 1 recall naming pembrolizumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pembrolizumab label say about other medicines?
The pembrolizumab label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name pembrolizumab. 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 |
|---|---|---|
| Axitinib | warnings and precautions | KEYTRUDA with Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. |
| Dexamethasone | warnings and precautions | … with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. ( 5.4 ) Embryo-Fetal toxicity: |
| Prednisone | warnings and precautions | In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Other labels that name pembrolizumab
Source: FDA drug label (KEYTRUDA), Merck Sharp & Dohme LLC, effective July 10, 2026 (SPL set 9333c79b-d487-4538-a9f0-71b91a02b287), via openFDA; the full label on DailyMed
What do FAERS reports show for pembrolizumab?
The FDA Adverse Event Reporting System holds 104,596 reports that list pembrolizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,742 are coded as a death and 43,925 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 pembrolizumab?
22 other medicines are given the same way (intravenous) and in the same FDA class as pembrolizumab 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 (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Nivolumab | Lung cancer, Colorectal cancer, Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Docetaxel | Breast cancer, Lung cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer, Lung cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer, Lung cancer | 10 labelers | n/a | No current entry |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Bevacizumab | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as pembrolizumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pembrolizumab
- 22 medicines for the same use
- Other programmed death receptor-1 blocking antibodys
- the pharmacologic class, with prices and generics
- Pembrolizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other