Durvalumab: uses, dosing, side effects & brands
Durvalumab is a programmed death ligand-1 blocker sold in the U.S. under one brand, for transitional cell carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Programmed Death Ligand-1 Blocker
- Treats
- Transitional Cell Carcinoma
- Available as
- Injectable
- Sold as
- Imfinzi
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How durvalumab is dosed
From the FDA label for Imfinzi (application BLA761069). Other durvalumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer IMFINZI as an intravenous infusion over 60 minutes after dilution. ( 2.4 ) • Neoadjuvant and Adjuvant Treatment of Resectable NSCLC: ∘ Weight ≥ 30 kg: Neoadjuvant : IMFINZI 1,500 mg in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery. Adjuvant : IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery. ( 2.2 ) ∘ Weight < 30 kg Neoadjuvant : IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy for up to 4 cycles prior to surgery. Adjuvant : IMFINZI 20 mg/kg every 4 weeks as a single agent for up to 12 cycles after surgery. ( 2.2 ) • Unresectable Stage III NSCLC, following concurrent platinum-based chemotherapy and radiation therapy: ∘ Weight ≥ 30 kg: IMFINZI 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks. ( 2.2 ) ∘ Weight < 30 kg: IMFINZI 10 mg/kg every 2 weeks. ( 2.2 ) • Metastatic NSCLC: ∘ Weight ≥ 30 kg: IMFINZI 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then administer IMFINZI 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of tremelimumab-actl 75 mg in combination with IMFINZI dose 6 at week 16. ( 2.2 ) ∘ Weight < 30 kg: IMFINZI 20 mg/kg every 3 weeks in combination with tremelimumab-actl 1 mg/kg and platinum-based chemotherapy, and then…
Durvalumab side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling. • Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ]. • Infusion-Related Reactions [see Warnings and Precautions (5.2) ]. IMFINZI in Combination with Chemotherapy • Most common adverse reactions (≥ 20%) of patients with resectable, Stage II/III NSCLC [neoadjuvant /adjuvant]) are anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. ( 6.1 ) IMFINZI as a Single Agent • Most common adverse reactions (≥ 20%) of patients with unresectable, Stage III NSCLC) are cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. ( 6.1 ) IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemothe rapy • Most common adverse reactions (≥ 20%) of patients with metastatic NSCLC) are nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea. ( 6.1 ) IMFINZI as a Single Agent • Most common adverse reactions (≥ 20%) of patients with limited-stage SCLC) are pneumonitis or radiation pneumonitis, and fatigue. ( 6.1 ) IMFINZI in Combination with Platinum-Based Chemotherapy • Most common adverse reactions (≥ 20%) of patients with extensive-stage SCLC) are nausea, fatigue/asthenia, and alopecia. ( 6.1 ) IMFINZI in Combination with Gemcitabine and Cisplatin • Most common adverse reactions (≥…
Who shouldn’t take durvalumab
None. None. ( 4 )
Every durvalumab 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: Imfinzi.
Durvalumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for durvalumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of durvalumab during breastfeeding. Because durvalumab is a large protein molecule with a molecular weight of about 146,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, durvalumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that mothers not breastfeed during treatment and for 3 months after the last dose of durvalumab.
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 durvalumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7,758 reports naming durvalumab, and the FDA flagged 98% 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 progression477 reports
- pyrexia334 reports
- pneumonitis323 reports
- diarrhoea275 reports
- pneumonia235 reports
- asthenia217 reports
- fatigue214 reports
- anaemia213 reports
Read these as a signal, not a rate. A report does not mean durvalumab 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
Frequently asked questions
What is durvalumab?
Imfinzi (Durvalumab) is a programmed death ligand-1 blocker used to treat Transitional Cell Carcinoma.
What kind of drug is durvalumab?
The FDA classifies durvalumab as a programmed death ligand-1 blocker. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take durvalumab 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 durvalumab 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 durvalumab come in?
Across the brands we track, durvalumab 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 durvalumab?
We do not currently list a generic-labelled durvalumab 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.
Cite this page
- APA
- pharmaranks. (2026, July 24). Durvalumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/durvalumab
- MLA
- “Durvalumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/durvalumab.
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 durvalumab on DailyMed (NIH) ↗.