Prescription medicine
Nivolumab Brand names: Opdivo
Nivolumab (Opdivo) 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 nivolumab FDA label on DailyMed (effective August 12, 2026, E.R. Squibb & Sons, L.L.C.); the BLA 125554 record on Drugs@FDA; every nivolumab label on DailyMed.
Highlights of the record
FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma
adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab.
Forms and strengths
- 10 mg/ml
Injection.
On the market
- Earliest approval on file
- December 22, 2014 Opdivo, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 96,109 through July 30, 2026
What is nivolumab used for?
From the label: indications and usageOPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma
adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1)
for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2) Non-Small Cell Lung Cancer (NSCLC)
adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. […]
Conditions named in the indications of nivolumab's FDA labels, with every medicine labeled for each:
From other nivolumab labelsLung cancer: adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy.
Leukemia, lymphoma and myeloma: OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
Colorectal cancer: Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer
FDA pharmacologic class: Programmed Death Receptor-1 Blocking Antibody.
Source: FDA drug label (OPDIVO), E.R. Squibb & Sons, L.L.C., effective August 12, 2026 (SPL set f570b9c4-6846-4de2-abfa-4d0a4ae4e394), via openFDA; the full label on DailyMed
What does the patient leaflet for nivolumab 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 OPDIVO?OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination with another therapy. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. • cough • shortness of breath • chest pain 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 OPDIVO. 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 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 Rejection of a transplanted organ or tissue. […]
Source: FDA drug label (OPDIVO), E.R. Squibb & Sons, L.L.C., effective August 12, 2026 (SPL set f570b9c4-6846-4de2-abfa-4d0a4ae4e394), via openFDA; the full label on DailyMed
Is there a generic for nivolumab (Opdivo)?
No generic nivolumab 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 nivolumab been recalled?
The FDA's Enforcement Report lists 1 recall naming nivolumab 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 nivolumab label say about other medicines?
The nivolumab label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name nivolumab. 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 |
|---|---|---|
| Cabozantinib | warnings and precautions | OPDIVO with Cabozantinib OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. |
| Dexamethasone | warnings and precautions | Treatment of patients 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. |
| Infliximab | warnings and precautions | Four patients required addition of infliximab to high-dose corticosteroids. |
| Ipilimumab | warnings and precautions | OPDIVO with Ipilimumab OPDIVO 3 mg/kg with Ipilimumab 1 mg/kg: In NSCLC, immune-mediated pneumonitis occurred in 9% (50/576) of patients receiving OPDIVO 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4%) immune-mediated pneumonitis. |
| Levothyroxine | warnings and precautions | Approximately 79% of patients with hypothyroidism received levothyroxine. |
| Methimazole | warnings and precautions | Approximately 19% of patients with hyperthyroidism received methimazole, 7% received carbimazole, and 4% received propylthiouracil. |
| Mycophenolic acid | warnings and precautions | Two patients required the addition of mycophenolic acid to high-dose corticosteroids. |
| Prednisone | warnings and precautions | In general, if OPDIVO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
| Propylthiouracil | warnings and precautions | Approximately 19% of patients with hyperthyroidism received methimazole, 7% received carbimazole, and 4% received propylthiouracil. |
Source: FDA drug label (OPDIVO), E.R. Squibb & Sons, L.L.C., effective August 12, 2026 (SPL set f570b9c4-6846-4de2-abfa-4d0a4ae4e394), via openFDA; the full label on DailyMed
What do FAERS reports show for nivolumab?
The FDA Adverse Event Reporting System holds 96,109 reports that list nivolumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24,663 are coded as a death and 39,168 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 nivolumab?
18 other medicines are given the same way (intravenous) and in the same FDA class as nivolumab 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 |
|---|---|---|---|---|
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Pembrolizumab | Lung cancer, Colorectal cancer, Leukemia, lymphoma and myeloma | 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 |
| Bevacizumab-maly | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nivolumab
- 18 medicines for the same use
- Other programmed death receptor-1 blocking antibodys
- the pharmacologic class, with prices and generics
- Nivolumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other