Skip to content
Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PEGVALIASE-PQPZ: 7,362 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
7,362
Total FAERS Reports
12 (0.2%)
Deaths Reported
251
Hospitalizations
7,362
As Primary/Secondary Suspect
71
Life-Threatening
4
Disabilities
Prescription
Status

FDA Application: 761079 ·

First Report: 20020628 · Latest Report: 20250924

What Are the Most Common PEGVALIASE-PQPZ Side Effects?

#1 Most Reported
Arthralgia
1,289 reports (17.5%)
#2 Most Reported
Injection site reaction
835 reports (11.3%)
#3 Most Reported
Injection site erythema
678 reports (9.2%)

All PEGVALIASE-PQPZ Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Arthralgia 1,289 17.5% 0 15
Injection site reaction 835 11.3% 0 4
Injection site erythema 678 9.2% 0 3
Injection site swelling 498 6.8% 0 1
Rash 460 6.3% 0 11
Urticaria 460 6.3% 0 15
Headache 403 5.5% 0 5
Injection site pain 388 5.3% 0 1
Fatigue 348 4.7% 0 8
Injection site pruritus 331 4.5% 0 3
Pruritus 312 4.2% 0 4
Hypersensitivity 310 4.2% 0 11
Dizziness 297 4.0% 0 21
Dyspnoea 290 3.9% 1 45
Nausea 284 3.9% 0 22
Anaphylactic reaction 282 3.8% 0 36
Off label use 271 3.7% 0 8
Vomiting 216 2.9% 0 22
Pyrexia 207 2.8% 0 16
Injection site bruising 196 2.7% 0 1

Who Reports PEGVALIASE-PQPZ Side Effects? Age & Gender Data

Gender: 61.2% female, 38.8% male. Average age: 32.3 years. Most reports from: US. View detailed demographics →

Is PEGVALIASE-PQPZ Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2015 1 0 0
2018 144 0 4
2019 534 0 16
2020 586 1 24
2021 438 1 34
2022 303 1 28
2023 374 2 33
2024 337 3 27
2025 254 0 18

View full timeline →

What Is PEGVALIASE-PQPZ Used For?

IndicationReports
Phenylketonuria 5,436
Product used for unknown indication 1,903
Hyperphenylalaninaemia 29
Foetal exposure during pregnancy 9

PEGVALIASE-PQPZ vs Alternatives: Which Is Safer?

PEGVALIASE-PQPZ vs PEGVISOMANT PEGVALIASE-PQPZ vs PEGZEREPOETIN ALFA PEGVALIASE-PQPZ vs PEMBROLIZUMAB PEGVALIASE-PQPZ vs PEMETREXED PEGVALIASE-PQPZ vs PEMIGATINIB PEGVALIASE-PQPZ vs PENICILLAMINE PEGVALIASE-PQPZ vs PENICILLIN PEGVALIASE-PQPZ vs PENICILLIN G PEGVALIASE-PQPZ vs PENICILLIN G BENZATHINE PEGVALIASE-PQPZ vs PENICILLIN G PROCAINE

Official FDA Label for PEGVALIASE-PQPZ

Official prescribing information from the FDA-approved drug label.