Prescription medicine
Teplizumab Brand names: Tzield
Teplizumab (Tzield) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the teplizumab FDA label on DailyMed (effective August 14, 2026); every teplizumab label on DailyMed.
Highlights of the record
FDA label of August 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Viral Reactivation Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. Severe lymphopenia may be prolonged in adults. ( 5.1 , 5.4 ) Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection). Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD. ( 2.6 , 4 , 5.1 , 5.4 ) WARNING: Viral Reactivation Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. […]
Used for
From the label: indications and usageTZIELD is indicated to [see Dosage and Administration (2.1) ]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D.
Forms and strengths
- 1 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 566 through July 30, 2026
What is teplizumab used for?
From the label: indications and usageTZIELD is indicated to [see Dosage and Administration (2.1) ]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). […]
Conditions named in the indications of teplizumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD3-directed Antibody.
Source: FDA drug label (TZIELD), Provention Bio, Inc., effective August 14, 2026 (SPL set e8a39a5f-139c-4510-9777-71cbb00138fa), via openFDA; the full label on DailyMed
What does the patient leaflet for teplizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TZIELD?TZIELD may cause serious side effects, including: Viral Reactivation. Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common viruses that may stay inactive in your body after an initial infection. TZIELD may cause these viruses to become active again which, especially in people with a weakened immune system, can become serious and potentially life-threatening. These infections can happen during treatment with TZIELD and for up to 2 months after your last dose. Your healthcare provider will test you for active EBV and CMV infections before treatment with TZIELD. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD (such as fever, swollen glands, or fatigue). Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include: fever nausea with or without vomiting feeling tired (fatigue) headache muscle and joint pain increased liver enzymes in your blood These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD. Serious Infections: Treatment with TZIELD may lower your immune system's ability to fight infections, which may increase your risk of getting a serious infection. TZIELD is not recommended if you currently have a serious infection, or an infection that keeps coming back or does not go away (chronic infection), other than a minor skin infection. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD such as. fever or chills redness, warmth, or swelling of the skin feeling tired cough or shortness of breath severe stomach pain or diarrhea Decrease in white blood cells. […]
Source: FDA drug label (TZIELD), Provention Bio, Inc., effective August 14, 2026 (SPL set e8a39a5f-139c-4510-9777-71cbb00138fa), via openFDA; the full label on DailyMed
Is there a generic for teplizumab (Tzield)?
No generic teplizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for teplizumab?
The FDA Adverse Event Reporting System holds 566 reports that list teplizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 21 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Teplizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other