What the label lists and what reports show
Nadofaragene firadenovec side effects
Nadofaragene firadenovec's FDA label: “The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood …” FAERS holds 492 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 instillation site discharge (107 reports).
- No generic listed
Check it at the source: the nadofaragene firadenovec FDA label on DailyMed (effective March 24, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ADSTILADRIN?The most common side effects of ADSTILADRIN include: Urinary discharge Fatigue Bladder spasm Urgency to urinate Blood in your urine These common side effects (above) are not all the possible side effects of ADSTILADRIN. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Ferring Pharmaceuticals at 1-888-337-7464. How is ADSTILADRIN used? Once every 3 months your healthcare provider will administer 75 mL (about 2 and a half ounces) of ADSTILADRIN into your bladder through a urinary catheter and leave it there for 1 hour. During this time your healthcare provider may move you about every 15 minutes. […]
Source: FDA drug label, Ferring Pharmaceuticals Inc., effective March 24, 2026 (SPL set 5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).
Table 1: Adverse Reactions (>10%) in Patients with NMIBC in CS-003
| Reaction | ADSTILADRIN Grade 1 and 2 (n=157) % - | ADSTILADRIN Grade 3 (n=157)% - |
|---|---|---|
| Instillation site discharge | 33 | 0 |
| Fatigue | 24 | 0 |
| Pyrexia | 16 | 0 |
| Chills | 15 | 0 |
| Bladder spasm | 20 | 1 |
| Micturition urgency | 19 | 1 |
| Hematuria | 17 | 1 |
| Dysuria | 16 | 0 |
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 most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ADSTILADRIN was evaluated in Study CS-003, a multicenter, single-arm, open-label study in 157 U.S. patients [ see Clinical Studies (14 ) ] with high-risk BCG‑unresponsive NMIBC, 107 of whom had BCG-unresponsive carcinoma in situ (CIS) with or without papillary tumors. Patients received 75 mL (3 x 10 11 vp/mL) ADSTILADRIN administered intravesically once every 3 months for up to 12 months [ see Clinical Studies (14 ) ]. All patients with an absence of high-risk recurrence or progression were offered continued treatment every 3 months beyond 12 months. …
Source: FDA drug label, Ferring Pharmaceuticals Inc., effective March 24, 2026 (SPL set 5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa), via openFDA; the full label on DailyMed
What do FAERS reports show?
492 reports list nadofaragene firadenovec among the medicines taken, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 33 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 21 reactions below, 8 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?
- Nadofaragene firadenovec: 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