OpenClaim

Piflufolastat Side Effects

The most commonly reported side effects of piflufolastat include radioisotope scan abnormal, product dispensing error, and product preparation error, based on 194 FDA adverse event reports from 2021 to 2025. 27.3% of reports found the drug to be ineffective.

Piflufolastat side effects

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

1
Radioisotope Scan Abnormal39.2%76
2
Drug Ineffective27.3%53
3
Product Dispensing Error17.5%34
4
Product Preparation Error7.2%14
5
Product Dose Omission Issue5.7%11
6
Intercepted Product Dispensing Error4.6%9
7
Fatigue3.1%6
8
Dizziness3.1%6
9
Wrong Product Administered3.1%6
10
Product Dose Omission In Error3.1%6
11
Product Administration Error2.6%5
12
Nausea2.1%4
13
Off Label Use2.1%4
14
Tongue Neoplasm Malignant Stage Unspecified2.1%4
15
Underdose1.5%3

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

Report severity

6.2%Serious12 reports
2.1%Hospitalizations4 reports
0.0%Fatal0 reports

Seriousness is determined by the reporter, not by OpenClaim.

Piflufolastat drug interactions

Other drugs that appear in adverse event reports alongside piflufolastat. 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
Darolutamide1.5%3
2
Bicalutamide1.0%2
3
Fludeoxyglucose-f-181.0%2
4
Degarelix-acetate1.0%2
5
Relugolix0.5%1
6
Acetaminophen0.5%1

Taken alongside

1
Omeprazole3.6%7
2
Atorvastatin-calcium3.1%6
3
Metoprolol3.1%6
4
Relugolix2.6%5
5
Amlodipine2.6%5
6
Tamsulosin-hydrochloride2.1%4
7
Tadalafil2.1%4
8
Aspirin2.1%4
9
Lisinopril2.1%4
10
Losartan-potassium2.1%4
11
Rosuvastatin2.1%4
12
Metformin1.5%3
13
Ergocalciferol1.5%3
14
Barium-sulfate1.5%3
15
Iohexol1.5%3

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 piflufolastat side effects

2.1% of piflufolastat adverse event reports involve female patients and 70.1% involve male patients. The largest age group is elderly at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female2.1%
Male70.1%
Unknown27.8%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6423.0%
65+77.0%

What is piflufolastat used for

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

Imaging ProcedureProduct Used For Unknown IndicationPositron Emission TomogramPositron Emission Tomogram ProstateProduct Used For Unknown IndicationProstate CancerProstate Cancer RecurrentProstate ExaminationProstatic Specific Antigen IncreasedScanScan With ContrastUltrasound Scan

Piflufolastat brand names and reporting trend

Quarterly reports (20212025)

2021202220242025

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

Taking piflufolastat with another medication?

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