What the label lists and what reports show
Durvalumab side effects
Durvalumab's FDA label: “Most common adverse reactions (≥ 20%) of patients with resectable, Stage II/III NSCLC [neoadjuvant /adjuvant]) are anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.” FAERS holds 20,225 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is malignant neoplasm progression (1,599 reports).
- No generic listed
Check it at the source: the durvalumab FDA label on DailyMed (effective August 31, 2026, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 20%) of patients with resectable, Stage II/III NSCLC [neoadjuvant /adjuvant]) are anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
Table 9. Adverse Reactions (≥ 10%) in Patients with NSCLC Who Received IMFINZI in the POSEIDON Study
| Adverse Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Nausea | 42 | 1.8 | 37 | 2.1 |
| Diarrhea | 22 | 1.5 | 15 | 1.5 |
| Constipation | 19 | 0 | 24 | 0.6 |
| Vomiting | 18 | 1.2 | 14 | 1.5 |
| Stomatitis Includes mucosal inflammation and stomatitis. | 10 | 0 | 6 | 0.3 |
| Fatigue/Asthenia Includes asthenia and fatigue. | 36 | 5 | 32 | 4.5 |
| Pyrexia Includes body temperature increased, hyperpyrexia, hyperthermia, and pyrexia. | 19 | 0 | 8 | 0 |
| Edema Includes face edema, localized edema, and edema peripheral. | 10 | 0 | 10 | 0.6 |
| Musculoskeletal Pain Includes arthralgia, arthritis, back pain, bone pain,… | 29 | 0.6 | 22 | 1.5 |
| Decreased appetite | 28 | 1.5 | 25 | 1.2 |
| Rash Includes eczema, erythema, dermatitis, drug eruption, erythema multiforme,… | 27 | 2.4 | 10 | 0.6 |
| Pruritus | 11 | 0 | 4.5 | 0 |
| Alopecia | 10 | 0 | 6 | 0 |
| Pneumonia Includes lower respiratory tract infection, pneumocystis jirovecii pneumonia,… | 17 | 8 | 12 | 4.2 |
| Upper respiratory tract infections Includes laryngitis, nasopharyngitis, pharyngitis,… | 15 | 0.6 | 9 | 0.9 |
| Hypothyroidism Includes blood thyroid stimulating hormone increased and hypothyroidism. | 13 | 0 | 2.1 | 0 |
| Cough/Productive Cough Includes cough and productive cough. | 12 | 0 | 8 | 0.3 |
| Headache Includes headache and migraine. | 11 | 0 | 8 | 0.6 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective August 31, 2026 (SPL set 8baba4ea-2855-42fa-9bd9-5a7548d4cec3), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,225 reports list durvalumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,343 are coded as a death and 5,977 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. Of the 22 reactions below, 20 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Durvalumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions