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Pafolacianine Side Effects

The most commonly reported side effects of pafolacianine include nausea, vomiting, and death, based on 51 FDA adverse event reports from 2013 to 2025.

Pafolacianine side effects

Percentages show how often each reaction appears relative to total reports for pafolacianine.

1
Nausea49.0%25
2
Vomiting27.5%14
3
Death7.8%4
4
Dyspnoea7.8%4
5
Pruritus7.8%4
6
Chest Discomfort7.8%4
7
Drug Effect Less Than Expected7.8%4
8
Off Label Use5.9%3
9
Methaemoglobinaemia5.9%3
10
Supraventricular Tachycardia5.9%3
11
Delirium5.9%3
12
Depressed Level Of Consciousness5.9%3
13
Mental Status Changes5.9%3
14
Hypoxia5.9%3
15
Cyanosis5.9%3

These are voluntary reports and do not establish that pafolacianine caused these reactions.

Report severity

29.4%Serious15 reports
21.6%Hospitalizations11 reports
7.8%Fatal4 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pafolacianine drug interactions

Other drugs that appear in adverse event reports alongside pafolacianine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fingolimod2.0%1
2
Azathioprine2.0%1
3
Prednisolone2.0%1
4
Istradefylline2.0%1
5
Triheptanoin2.0%1
6
Bevacizumab2.0%1
7
Dapsone2.0%1

Taken alongside

1
Ondansetron7.8%4
2
Dimenhydrinate5.9%3
3
Amlodipine5.9%3
4
Candesartan-cilexetil5.9%3
5
Diphenhydramine3.9%2
6
Gabapentin2.0%1
7
Acetaminophen2.0%1
8
Oxycodone2.0%1
9
Cyclobenzaprine-hydrochloride2.0%1
10
Sertraline-hydrochloride2.0%1
11
Zolpidem-tartrate2.0%1
12
Alprazolam2.0%1
13
Atropine2.0%1
14
Diphenoxylate-hydrochloride2.0%1
15
Solifenacin-succinate2.0%1

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pafolacianine side effects

66.7% of pafolacianine adverse event reports involve female patients and 31.4% involve male patients. The largest age group is adult at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female66.7%
Male31.4%
Unknown2.0%

Age group

< 20.0%
2–112.6%
12–170.0%
18–6450.0%
65+47.4%

What is pafolacianine used for

Conditions and purposes for which patients were taking pafolacianine when the adverse event was reported.

Adjuvant TherapyContrast Media DepositionLung Neoplasm MalignantMetastases To LungNeoplasm MalignantNoduleOsteosarcoma MetastaticOvarian CancerOvarian Epithelial CancerProduct Used For Unknown IndicationProduct Used For Unknown IndicationSurgery

Pafolacianine brand names and reporting trend

Pafolacianine is sold under the brand name Cytalux.

Brand names

Cytalux6

Quarterly reports (20132025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pafolacianine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.