OpenClaim

Pegvaliase Side Effects

The most commonly reported side effects of pegvaliase include arthralgia, injection site reaction, and injection site erythema, based on 7,641 FDA adverse event reports from 2018 to 2025.

#1 Reported: ArthralgiaAll side effects ↓Top Co-Medication: Sapropterin-dihydrochlorideDrug interactions ↓95% of Reports Are AdultDemographics ↓

Pegvaliase side effects

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

1
Arthralgia17.2%1,316
2
Injection Site Reaction11.2%855
3
Injection Site Erythema9.0%690
4
Injection Site Swelling6.7%510
5
Rash6.2%473
6
Urticaria6.2%471
7
Headache5.5%417
8
Injection Site Pain5.2%397
9
Fatigue4.7%362
10
Injection Site Pruritus4.4%339
11
Hypersensitivity4.3%327
12
Pruritus4.2%318
13
Dizziness4.0%308
14
Dyspnoea4.0%304
15
Anaphylactic Reaction3.9%300

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

Report severity

15.7%Serious1,203 reports
3.5%Hospitalizations271 reports
0.2%Fatal12 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pegvaliase drug interactions

Other drugs that appear in adverse event reports alongside pegvaliase. 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
Sapropterin-dihydrochloride6.5%493
2
Cetirizine-hydrochloride0.2%13
3
Diphenhydramine0.1%10
4
Ranitidine0.1%10
5
Famotidine<0.1%7
6
Ibuprofen<0.1%7
7
Acetaminophen<0.1%6
8
Loratadine<0.1%6
9
Aspirin<0.1%6
10
Omeprazole<0.1%5
11
Semaglutide<0.1%5
12
Amoxicillin<0.1%4
13
Oseltamivir-phosphate<0.1%3
14
Sertraline-hydrochloride<0.1%3
15
Albuterol<0.1%3

Taken alongside

1
Cetirizine-hydrochloride17.8%1,359
2
Famotidine15.3%1,172
3
Epinephrine10.2%783
4
Ibuprofen4.0%309
5
Loratadine3.9%300
6
Ergocalciferol3.8%289
7
Albuterol3.5%266
8
Diphenhydramine3.5%265
9
Acetaminophen3.2%243
10
Omeprazole3.1%235
11
Ranitidine2.6%200
12
Fluticasone2.1%159
13
Buspirone-hydrochloride2.0%153
14
Montelukast-sodium2.0%151
15
Naproxen2.0%150

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 pegvaliase side effects

32.8% of pegvaliase adverse event reports involve female patients and 20.9% involve male patients. The largest age group is adult at 95%. These figures reflect who reports side effects, not underlying risk.

Sex

Female32.8%
Male20.9%
Unknown46.3%

Age group

< 20.1%
2–110.1%
12–174.5%
18–6495.0%
65+0.2%

What is pegvaliase used for

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

Amino Acid Level AbnormalAmino Acid Level IncreasedAnxiety DisorderAromatic L-amino Acid Decarboxylase DeficiencyBipolar DisorderFoetal Exposure During PregnancyFoetal Exposure During PregnancyGalactosaemiaGeneralised Anxiety DisorderGlycogen Storage DisorderHyperphenylalaninaemiaHyperphenylalaninaemiaKetonuriaMajor DepressionPhenylketonuria

Showing 15 of 19 indications

Pegvaliase brand names and reporting trend

Pegvaliase is sold under the brand name Palynziq.

Brand names

Palynziq41

Quarterly reports (2018–2025)

20182020202220242025

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

Taking pegvaliase with another medication?

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

Check my medications