Prescription medicine
Porfimer Brand names: Photofrin
Porfimer (Photofrin) is a prescription medicine with an FDA approval on record since 1995. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the porfimer FDA label on DailyMed (effective April 28, 2026, Pinnacle Biologics, Inc.); the NDA 20451 record on Drugs@FDA; every porfimer label on DailyMed.
Highlights of the record
FDA label of April 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCL
Forms and strengths
- 75 mg/31.8ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- December 27, 1995 Photofrin, Pinnacle Biolgs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest February 10, 2014
- FAERS reports
- 341 through July 30, 2026
What is porfimer used for?
From the label: indications and usagePHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia […]
FDA pharmacologic class: Photoactivated Radical Generator.
Source: FDA drug label (Photofrin), Pinnacle Biologics, Inc., effective April 28, 2026 (SPL set 5c4841b4-fbc0-4163-8ee1-cb28629cbfbf), via openFDA; the full label on DailyMed
Is there a generic for porfimer (Photofrin)?
No generic porfimer is approved (Drugs@FDA, October 8, 2026).
- 1995 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has porfimer been recalled?
The FDA's Enforcement Report lists 1 recall naming porfimer since 2014: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 10, 2014 | Class III | Pinnacle Biologics Inc | Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the porfimer label say about other medicines?
The porfimer label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Griseofulvin | drug interactions | The concomitant use of PHOTOFRIN with other photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) may increase the risk of a photosensitivity reaction. |
Source: FDA drug label (Photofrin), Pinnacle Biologics, Inc., effective April 28, 2026 (SPL set 5c4841b4-fbc0-4163-8ee1-cb28629cbfbf), via openFDA; the full label on DailyMed
What do FAERS reports show for porfimer?
The FDA Adverse Event Reporting System holds 341 reports that list porfimer among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 74 are coded as a death and 103 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other photoactivated radical generators
- the pharmacologic class, with prices and generics
- Porfimer side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other