OpenClaim

Trofinetide Side Effects

The most commonly reported side effects of trofinetide include diarrhoea, underdose, and vomiting, based on 5,346 FDA adverse event reports from 2023 to 2025. 7.6% of reports found the drug to be ineffective.

Trofinetide side effects

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

1
Diarrhoea55.7%2,977
2
Underdose31.6%1,690
3
Vomiting18.0%960
4
Product Dose Omission Issue14.4%770
5
Seizure12.7%679
6
Constipation10.7%573
7
Product Use Complaint9.5%510
8
Weight Decreased8.8%472
9
Drug Ineffective7.6%407
10
Intentional Dose Omission7.0%376
11
Decreased Appetite6.7%359
12
Nasopharyngitis6.1%326
13
Faeces Soft5.9%316
14
Flatulence5.7%305
15
Inappropriate Schedule Of Product Administration5.5%293

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

Report severity

28.6%Serious1,527 reports
12.1%Hospitalizations647 reports
0.6%Fatal30 reports

Seriousness is determined by the reporter, not by OpenClaim.

Trofinetide drug interactions

Other drugs that appear in adverse event reports alongside trofinetide. 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
Loperamide-hydrochloride0.5%29
2
Amoxicillin0.4%24
3
Polyethylene-glycol-33500.3%15
4
Clavulanate-potassium0.2%12
5
Levetiracetam0.2%12
6
Clobazam0.1%8
7
Oxcarbazepine0.1%6
8
Cenobamate0.1%6
9
Topiramate<0.1%5
10
Zonisamide<0.1%5
11
Risperidone<0.1%5
12
Ergocalciferol<0.1%5
13
Fenfluramine<0.1%5
14
Clonidine<0.1%4
15
Lamotrigine<0.1%4

Taken alongside

1
Levetiracetam3.1%165
2
Polyethylene-glycol-33502.4%127
3
Diazepam2.1%110
4
Clonazepam1.6%88
5
Clobazam1.6%88
6
Lamotrigine1.6%88
7
Acetaminophen1.5%80
8
Clonidine1.4%77
9
Albuterol1.4%74
10
Oxcarbazepine1.3%72
11
Loperamide-hydrochloride1.3%70
12
Ergocalciferol1.3%69
13
Baclofen1.3%67
14
Cannabidiol1.2%63
15
Cetirizine-hydrochloride1.2%62

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 trofinetide side effects

89.7% of trofinetide adverse event reports involve female patients and 4.0% involve male patients. The largest age group is child at 48%. These figures reflect who reports side effects, not underlying risk.

Sex

Female89.7%
Male4.0%
Unknown6.3%

Age group

< 20.6%
2–1147.6%
12–1718.8%
18–6432.9%
65+<0.1%

What is trofinetide used for

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

Autism Spectrum DisorderBalance DisorderCatatoniaCornelia De Lange SyndromeDisease SusceptibilityEncephalopathyEpilepsyGenetic PolymorphismIll-defined DisorderImmobileInfluenzaIntellectual DisabilityLennox-gastaut SyndromeMicrocephalyNeurodevelopmental Disorder

Showing 15 of 20 indications

Trofinetide brand names and reporting trend

Trofinetide is sold under the brand name Daybue Stix.

Brand names

Daybue Stix30

Quarterly reports (20232025)

202320242025

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

Taking trofinetide with another medication?

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