Hexaminolevulinate: uses, dosing, side effects & brands
Hexaminolevulinate is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Kit
- Sold as
- Cysview Kit
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How hexaminolevulinate is dosed
From the FDA label for Cysview Kit (application NDA022555). Other hexaminolevulinate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended adult dose is 100 mg reconstituted in 50 mL of the supplied diluent instilled into the bladder via a urinary catheter and retained for 1 hour to 3 hours before evacuation. ( 2.1 ) Use an FDA-authorized blue light imaging device intended to perform blue light cystoscopy with hexaminolevulinate hydrochloride. ( 2.4 ) Perform cystosopic examination of the entire bladder first under white light and then under blue light. ( 2.5 ) For reconstitution, administration, and cystoscopic examination see full prescribing information. ( 2.2 , 2.3 , 2.5 ) 2.1 Recommended Dose The recommended dose for adults is 100 mg of CYSVIEW administered by bladder instillation. Reconstitute the CYSVIEW 100 mg powder in the vial with the supplied diluent to a final volume of 50 mL. Administer the entire 50 mL dose via a urinary catheter. The solution should be retained in the bladder for 1 hour to 3 hours following instillation. [see Dosage and Administration (2.2 , 2.3) ] . 2.2 Reconstitution of CYSVIEW General Instructions CYSVIEW is supplied as a kit with diluent for reconstitution, with or without a vial adapter for use during reconstitution [see How Supplied/Storage and Handling (16) ] . Perform all steps using aseptic technique. Wear gloves during the reconstitution procedure; skin exposure to CYSVIEW may increase the risk of sensitization to the drug. Reconstituted CYSVIEW has a…
Hexaminolevulinate side effects
The following clinically significant adverse reaction is discussed elsewhere in the Prescribing Information: Anaphylaxis [see Warnings and Precautions (5.1) ] . The most common adverse reaction was bladder spasm followed by dysuria, hematuria, and bladder pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Photocure Inc. at 1-855-297-8439 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 CYSVIEW was evaluated in 1,628 patients in seven clinical trials. Patients were aged 32 to 96 years with a median age of 70 years, 77% male, 88% White, 3% Black or African American, and 9% of unspecified racial group. All patients were evaluated after a single instillation of 100 mg of CYSVIEW, and 103 patients received a repeat administration of CYSVIEW [see Clinical Studies (14) ] . The most common adverse reaction was bladder spasm (reported in 2% of the patients) followed by dysuria, hematuria, and bladder pain. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of CYSVIEW. Because these reactions are reported voluntarily…
Who shouldn’t take hexaminolevulinate
CYSVIEW is contraindicated in patients with: Porphyria Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid Porphyria Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives ( 4 )
Every hexaminolevulinate 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: Cysview Kit.
What people report to the FDA about hexaminolevulinate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7 reports naming hexaminolevulinate, and the FDA flagged 100% 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:
- arthritis reactive2 reports
- cystitis noninfective2 reports
- post procedural complication2 reports
- agitation1 reports
- anaphylactic shock1 reports
- angina pectoris1 reports
- arthralgia1 reports
- blood pressure decreased1 reports
Read these as a signal, not a rate. A report does not mean hexaminolevulinate 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 hexaminolevulinate?
CYSVIEW (hexaminolevulinate hydrochloride) for intravesical solution is an optical imaging agent.
Can you take hexaminolevulinate 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 hexaminolevulinate 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 hexaminolevulinate come in?
Across the brands we track, hexaminolevulinate is currently marketed as kit, 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 hexaminolevulinate?
We do not currently list a generic-labelled hexaminolevulinate 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). Hexaminolevulinate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/hexaminolevulinate
- MLA
- “Hexaminolevulinate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/hexaminolevulinate.
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 hexaminolevulinate on DailyMed (NIH) ↗.