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Teplizumab Side Effects

The most commonly reported side effects of teplizumab include rash, nausea, and fatigue, based on 470 FDA adverse event reports from 2021 to 2025.

#1 Reported: RashAll side effects ↓Top Co-Medication: DiphenhydramineDrug interactions ↓67% of Reports Are AdultDemographics ↓

Teplizumab side effects

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

1
Rash23.4%110
2
Nausea22.3%105
3
Fatigue18.1%85
4
Pyrexia17.0%80
5
Headache13.8%65
6
Vomiting13.4%63
7
Pain7.4%35
8
Lymphocyte Count Decreased7.2%34
9
Rash Pruritic6.6%31
10
Chills6.4%30
11
Pruritus5.7%27
12
Diarrhoea5.3%25
13
White Blood Cell Count Decreased4.9%23
14
Lymphopenia4.3%20
15
Alanine Aminotransferase Increased4.3%20

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

Report severity

14.3%Serious67 reports
4.9%Hospitalizations23 reports
0.4%Fatal2 reports

Seriousness is determined by the reporter, not by OpenClaim.

Teplizumab drug interactions

Other drugs that appear in adverse event reports alongside teplizumab. 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
Diphenhydramine0.9%4
2
Carisoprodol0.2%1
3
Insulin0.2%1
4
Ondansetron0.2%1
5
Venetoclax0.2%1
6
Terlipressin-acetate0.2%1
7
Temozolomide0.2%1
8
Ibuprofen0.2%1
9
Hydrocortisone0.2%1

Taken alongside

1
Ibuprofen12.3%58
2
Diphenhydramine5.1%24
3
Ondansetron4.9%23
4
Acetaminophen4.5%21
5
Insulin2.3%11
6
Metformin1.9%9
7
Levothyroxine-sodium1.7%8
8
Ergocalciferol1.5%7
9
Cetirizine-hydrochloride1.3%6
10
Tirzepatide0.6%3
11
Semaglutide0.6%3
12
Pioglitazone-hydrochloride0.6%3
13
Cholecalciferol0.6%3
14
Losartan-potassium0.4%2
15
Spironolactone0.4%2

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 teplizumab side effects

50.0% of teplizumab adverse event reports involve female patients and 35.1% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female50.0%
Male35.1%
Unknown14.9%

Age group

< 20.0%
2–1113.4%
12–1717.0%
18–6467.4%
65+2.3%

What is teplizumab used for

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

Blood Glucose AbnormalDiabetes MellitusDiabetes ProphylaxisHypoglycaemiaMalignant Melanoma Stage IiiMetastases To Central Nervous SystemProduct Used For Unknown IndicationPresymptomatic Type 1 Diabetes MellitusProduct Used For Unknown IndicationType 1 Diabetes MellitusType 2 Diabetes Mellitus

Teplizumab brand names and reporting trend

Teplizumab is sold under the brand name Tzield.

Brand names

Tzield104

Quarterly reports (2021–2025)

202120242025

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

Taking teplizumab with another medication?

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

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