What the label lists and what reports show

Porfimer side effects

Porfimer's FDA label: “Most common adverse reactions (>10%) are Esophageal Cancer: Anemia, pleural effusion, pyrexia, constipation, nausea, chest pain, pain, abdominal pain, dyspnea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis ( 6.1 ) …” FAERS holds 341 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 cholangitis (42 reports).

No generic listed

Check it at the source: the porfimer FDA label on DailyMed (effective April 28, 2026, Pinnacle Biologics, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
Most common adverse reactions (>10%) are Esophageal Cancer: Anemia, pleural effusion, pyrexia, constipation, nausea, chest pain, pain, abdominal pain, dyspnea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis ( 6.1 ) Obstructing Endobronchial Cancer: Dyspnea, photosensitivity reaction, hemoptysis, pyrexia, cough, pneumonia ( 6.1 ) Superficial Endobronchial Tumors: Exudate, photosensitivity reaction, bronchial obstruction, edema, bronchostenosis […]

TABLE 7. Adverse Reactions Reported in 5% or More of Patients with Obstructing…

Reaction	SYSTEM ORGAN CLASS (SOC) PDT %	Adverse Reaction Nd:YAG %	Within 30 Days of Treatment PDT %	Entire Follow-up Period Follow-up was 33% longer for the PDT group than for the Nd:YAG… Nd:YAG %
Patients with at Least One Adverse Reaction	50	38	72	56
Bronchitis	10	2	10	2
Hemoptysis	7	6	16	8
Cough	6	9	15	13
Pneumonia	6	5	12	6
Productive cough	5	6	8	7
Respiratory insufficiency	0	0	6	1
Pleural effusion	0	0	5	1
Pneumothorax	0	0	0	5
Chest pain	7	7	8	9
Edema peripheral	3	3	5	3
Pain	1	5	5	9
Anxiety	3	0	6	0
Dyspepsia	1	5	2	6

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, continued
The following clinically significant adverse reactions are described elsewhere in the labeling: Gastroesophageal Fistula and Perforation [see Warnings and Precautions ( 5.1 )] Pulmonary and Gastroesophageal Hemorrhage [see Warnings and Precautions ( 5.2 )] High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE) [see Warnings and Precautions ( 5.3 )] Photosensitivity [see Warnings and Precautions ( 5.4 )] Ocular Sensitivity [see Warnings and Precautions ( 5.5 )] Use Before or After Radiotherapy [see Warnings and Precautions ( 5.6 )] Chest Pain [see Warnings and Precautions ( 5.7 )] Airway Obstruction and Respiratory Distress [see Warnings and Precautions ( 5.8 )] Esophageal Strictures [see Warnings and Precautions ( 5.9 )] Thromboembolism [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (>10%) are Esophageal Cancer: Anemia, pleural effusion, pyrexia, constipation, nausea, chest pain, pain, abdominal pain, dyspnea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis ( 6.1 ) Obstructing Endobronchial Cancer: Dyspnea, photosensitivity reaction, hemoptysis, pyrexia, cough, pneumonia ( 6.1 ) Superficial Endobronchial Tumors: Exudate, photosensitivity reaction, bronchial obstruction, edema, bronchostenosis ( 6.1 ) High-Grade Dysplasia in Barrett’s Esophagus: Photosensitivity reaction, esophageal stenosis, vomiting, chest pain, nausea …

Source: FDA drug label, 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?

341 reports list porfimer among the medicines taken, 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. Of the 24 reactions below, 16 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

Off Label Use (a use or a product term, not a reaction)72
Cholangitis42
Oesophageal Stenosis (named in the label)28
Dyspnoea (named in the label)19
Hypotension (named in the label)19
Sepsis (named in the label)15
Photosensitivity Reaction (named in the label)14
Pneumonia (named in the label)14
Post Procedural Complication (named in the label)14
Swelling Face13
Deep Vein Thrombosis12
Fatigue11
Nausea (named in the label)11
Pyrexia (named in the label)11
Atrial Fibrillation (named in the label)10
Gastrointestinal Haemorrhage10
Oedema Peripheral (named in the label)10
Pleural Effusion (named in the label)10
Haemoptysis (named in the label)9
Liver Abscess9
Pain9
Respiratory Failure (named in the label)9
Oesophageal Fistula8
Respiratory Distress (named in the label)8
Bronchial Obstruction (named in the label)7

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Porfimer: 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