Prescription medicine
Ipilimumab Brand names: Yervoy
Ipilimumab (Yervoy) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ipilimumab FDA label on DailyMed (effective August 20, 2026, E.R. Squibb & Sons, L.L.C.); the BLA 125377 record on Drugs@FDA; every ipilimumab label on DailyMed.
Highlights of the record
FDA label of August 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageYERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma
Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab.
Forms and strengths
- 5 mg/ml
Injection.
On the market
- Earliest approval on file
- March 25, 2011 Yervoy, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- No recall recorded
- FAERS reports
- 42,912 through July 30, 2026
What is ipilimumab used for?
From the label: indications and usageYERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma
Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1)
Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (1.2) Renal Cell Carcinoma (RCC)
Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. […]
Conditions named in the indications of ipilimumab's FDA labels, with every medicine labeled for each:
From other ipilimumab labelsLung cancer: Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab.
Colorectal cancer: Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer
FDA pharmacologic class: CTLA-4-directed Blocking Antibody.
Source: FDA drug label (YERVOY), E.R. Squibb & Sons, L.L.C., effective August 20, 2026 (SPL set 2265ef30-253e-11df-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What does the patient leaflet for ipilimumab 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 YERVOY?YERVOY is a medicine that may treat certain cancers by working with your immune system. YERVOY 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 may 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. Some of these problems may happen more often when YERVOY is used in combination with nivolumab. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including: Intestinal problems. • diarrhea (loose stools) or more frequent bowel movements than usual • stools that are black, tarry, sticky, or have blood or mucus • severe stomach-area (abdominal) pain or tenderness Liver problems. […] These are not all of the signs and symptoms of immune system problems that can happen with YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms. • Chest pain, irregular heartbeat, shortness of breath or 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 Getting medical treatment right away may help keep these problems from becoming more serious. […]
Source: FDA drug label (YERVOY), E.R. Squibb & Sons, L.L.C., effective August 20, 2026 (SPL set 2265ef30-253e-11df-8a39-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for ipilimumab (Yervoy)?
No generic ipilimumab is approved (Drugs@FDA, October 8, 2026).
- 2011 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ipilimumab label say about other medicines?
The ipilimumab label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name ipilimumab. 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 |
|---|---|---|
| Infliximab | warnings and precautions | Approximately 23% of patients required addition of infliximab to high-dose corticosteroids. |
| Levothyroxine | warnings and precautions | Approximately 89% of patients with hypothyroidism received levothyroxine. |
| Methimazole | warnings and precautions | Approximately 26% of patients with hyperthyroidism received methimazole and 21% received carbimazole. |
| Mycophenolic acid | warnings and precautions | Approximately 9% of patients with immune-mediated hepatitis required addition of mycophenolic acid to high-dose corticosteroids. |
| Nivolumab | warnings and precautions | YERVOY 1 mg/kg with 3 mg/kg Nivolumab Hypophysitis: YERVOY can cause immune-mediated hypophysitis. |
| Prednisone | warnings and precautions | In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
| Vemurafenib | warnings and precautions | In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg or 720 mg twice daily). |
Source: FDA drug label (YERVOY), E.R. Squibb & Sons, L.L.C., effective August 20, 2026 (SPL set 2265ef30-253e-11df-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show for ipilimumab?
The FDA Adverse Event Reporting System holds 42,912 reports that list ipilimumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,586 are coded as a death and 19,401 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 ipilimumab?
18 other medicines are given the same way (intravenous) and in the same FDA class as ipilimumab 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 |
|---|---|---|---|---|
| Tremelimumab | Lung cancer | none listed | n/a | No current entry |
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Bevacizumab | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ipilimumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ipilimumab
- 18 medicines for the same use
- Other ctla-4-directed blocking antibodys
- the pharmacologic class, with prices and generics
- Ipilimumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other