Nadofaragene firadenovec Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 14, 2024.

Applies to nadofaragene firadenovec: urinary bladder suspension.

Serious side effects

Along with its needed effects, nadofaragene firadenovec may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking nadofaragene firadenovec:

More common

• Blood in the urine
• burning while urinating
• chills
• difficult or painful urination
• fever
• trouble in holding or releasing urine
• unusual tiredness or weakness

Less common

• Anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain, discomfort, heaviness, or tightness
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased urination
• depression
• dizziness
• dry mouth
• fainting
• fast or irregular heartbeat
• headache
• lightheadedness
• nausea
• nervousness
• nightmares
• rapid breathing
• seizures
• shakiness
• slurred speech
• sunken eyes
• sweating
• thirst
• trouble breathing
• wrinkled skin

Rare

• Dilated neck veins
• blue or pale skin
• irregular breathing
• problems with movement, walking, or speech
• swelling of the face, fingers, feet, or lower legs
• vomiting
• weight gain

For Healthcare Professionals

Applies to nadofaragene firadenovec: intravesical suspension.

General

The most common adverse reactions reported in 10% or more patients including laboratory abnormalities in more than 15% patients, were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination) urgency, increased creatinine, hematuria (blood in urine), decreased phosphate, chills, dysuria, and pyrexia (fever).^[Ref]

Cardiovascular

Common (1% to 10%): Coronary artery disease, acute coronary syndrome, atrial fibrillation, heart failure, pericarditis^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (16%)^[Ref]

Metabolic

Very common (10% or more): Increased glucose (38%), increased triglycerides (30%), increased creatinine (17%), decreased phosphate (16%)

Common (1% to 10%): Dehydration, hypoglycemia, bile duct stone^[Ref]

Other

Very common (10% or more): Instillation site discharge (33%), fatigue (24%), chills (16%), pyrexia (15%)

Common (1% to 10%): Syncope, sepsis^[Ref]

Renal

Very common (10% or more): Bladder spasm (20%), micturition urgency (19%), hematuria (17%), dysuria (16%)^[Ref]

Nervous system

Common (1% to 10%): Brain edema^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer