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Nivolumab: uses, dosing, side effects & brands

Nivolumab is a medicine sold in the U.S. under one brand. 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

Available as
Injectable
Sold as
Opdivo
Prescription?
Prescription only
Generic available?
Not in our catalog

Every nivolumab 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: Opdivo.

Combination products containing nivolumab

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.

Nivolumab recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long nivolumab keeps

The date on a sealed pack is not the only one: some nivolumab labels start a second clock once the product is opened or mixed, as short as 8 hours.

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

Nivolumab and breastfeeding

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

Nivolumab milk levels in one mother were unexpectedly high and appeared to accumulate with repeated doses, possibly because it is an IgG4 antibody rather than the more typical IgG1 for other monoclonal antibodies It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. However, until more data become available, nivolumab should probably be avoided during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during nivolumab therapy and for 5 months after the last dose of the drug.

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

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about nivolumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 48,376 reports naming nivolumab, and the FDA flagged 96% 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:

  • malignant neoplasm progression5,245 reports
  • diarrhoea2,857 reports
  • fatigue2,174 reports
  • pyrexia2,051 reports
  • nausea1,795 reports
  • dyspnoea1,705 reports
  • pneumonia1,547 reports
  • pneumonitis1,498 reports

Read these as a signal, not a rate. A report does not mean nivolumab 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 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

Can you take nivolumab 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 nivolumab 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 nivolumab come in?

Across the brands we track, nivolumab 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 nivolumab?

We do not currently list a generic-labelled nivolumab 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.

Has nivolumab been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions nivolumab. The most recent: Opdualag (nivolumab and relatlimab-rmbw) injection (Oct 21, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

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

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 nivolumab on DailyMed (NIH) ↗.