FDA Adverse Events Reports (FAERS) Summary for TALTZ

These tables and charts are based on 35,113 total reports for TALTZ (IXEKIZUMAB) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 24,774 pharmaceutical company-submitted and non-U.S. FAERS reports and 10,339 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 10,339 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch TALTZ summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with TALTZ (reported in FAERS Database)

 Side Effect# of FDA Reports
1INJECTION SITE PAIN3815
2PSORIASIS3053
3DRUG INEFFECTIVE3006
4INJECTION SITE REDNESS2147
5INJECTION SITE REACTION1747
6INJECTION SITE SWELLING1613
7INCORRECT DOSE ADMINISTERED1162
8PRODUCT DOSE OMISSION ISSUE936
9COVID-19904
10PAIN864
11THERAPY INTERRUPTED826
12JOINT PAIN799
13RASH793
14INJECTION SITE ITCHING778
15DIARRHEA767
16ITCHING747
17NAUSEA703
18PSORIATIC ARTHRITIS688
19INJECTION SITE URTICARIA661
20INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION660

Latest Known Outcomes for Reactions Reported for TALTZ

Latest Known Outcome for Reported ReactionsNumber of Cases
1Unknown Outcome18964
2Patient recovered3933
3Patient has not recovered/symtoms have not resolved3569
4Patient is recovering/symptoms resolving1478
5Patient died401
6Patient has recovered but has consequent health issues57
Search all MedWatch and FAERS by keyword:

TALTZ Total Reports

 Male    Female    Unknown    Total  
 12389    19627    3097    35,113  

Top Countries Reporting

 Country  Number of Reports
United States  32006
Canada  670
France  389
Germany  379
Japan  234
EU  167
Spain  120
Italy  99
Brazil  90
10 United Kingdom  89

Outcomes for Reports

Serious: 6657
Not Serious: 28443
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications      
Psoriasis
Product used for unknown indication
PSORIATIC ARTHRITIS
Ankylosing spondylitis
Rheumatoid arthritis

Top Companies Reporting

   ELI LILLY AND COMPANY
   ELI LILLY AND CO

Safety-Related FDA Updates

FDA Approval Date: 2021-06-16

TALTZ (IXEKIZUMAB) Biological Drug:
Warnings about the risk of eczema-like skin eruptions and provides updated guidance for pediatric use age 6 to 17.
Safety-related Labeling Changes


Have experience (good or bad) with TALTZ? Rate TALTZ at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for TALTZ reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.