What the label lists and what reports show
Cefiderocol side effects
Cefiderocol's FDA label: “Common Adverse Reactions Table 4 lists the most common selected adverse reactions occurring in ≥ 2% of cUTI patients receiving FETROJA in Trial 1.” FAERS holds 303 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 drug resistance (31 reports).
- No generic listed
Check it at the source: the cefiderocol FDA label on DailyMed (effective February 24, 2026, Shionogi Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsCommon Adverse Reactions Table 4 lists the most common selected adverse reactions occurring in ≥ 2% of cUTI patients receiving FETROJA in Trial 1.
Table 4 Selected Adverse Reactions Occurring in ≥ 2% of cUTI Patients Receiving FETROJA in Trial 1
| Adverse Reaction | FETROJA 2 grams IV over 1 hour every 8 hours (with dosing adjustment based on renal… | Imipenem/Cilastatin 1 gram IV over 1 hour every 8 hours (with dosing adjustment based on… |
|---|---|---|
| Diarrhea | 4% | 6% |
| Infusion site reactions Infusion site reactions include infusion site erythema,… | 4% | 5% |
| Constipation | 3% | 4% |
| Rash Rash includes rash macular, rash maculopapular, erythema, skin irritation. | 3% | < 1% |
| Candidiasis Candidiasis includes oral or vulvovaginal candidiasis, candiduria. | 2% | 3% |
| Cough | 2% | < 1% |
| Elevations in liver tests Elevations in liver tests include alanine aminotransferase,… | 2% | < 1% |
| Headache | 2% | 5% |
| Hypokalemia Hypokalemia includes blood potassium decreased. | 2% | 3% |
| Nausea | 2% | 4% |
| Vomiting | 2% | 1% |
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 serious adverse reactions are described in greater detail in the Warnings and Precautions section: Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated Diarrhea (CDAD) [see Warnings and Precautions (5.3) ] Seizures and Other Central Nervous System Adverse Reactions [see Warnings and Precautions (5.4) ] cUTI: The most frequently occurring adverse reactions in greater than or equal to 2% of cUTI patients treated with FETROJA were diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea, and vomiting. ( 6.1 ) HABP/VABP: The most frequently occurring adverse reactions in greater than or equal to 4% of HABP/VABP patients treated with FETROJA were elevations in liver tests, hypokalemia, diarrhea, hypomagnesemia, and atrial fibrillation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-800-849-9707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Shionogi Inc., effective February 24, 2026 (SPL set 75c0c785-38e0-4049-a6fb-b77581f5b35c), via openFDA; the full label on DailyMed
What do FAERS reports show?
303 reports list cefiderocol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 145 are coded as a death and 61 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 16 reactions below, 6 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.
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?
- Cefiderocol: 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