Skip to main content

What the label lists and what reports show

Ixekizumab side effects

Ixekizumab's FDA label: “Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.” FAERS holds 36,780 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is injection site pain (3,901 reports).

  • No generic listed

Check it at the source: the ixekizumab FDA label on DailyMed (effective January 22, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of TALTZ?

TALTZ may cause serious side effects, including: See “ What is the most important information I should know about TALTZ? ” Serious allergic reactions. If you have a severe allergic reaction, do not give another injection of TALTZ. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: feel faint swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash Severe skin reactions that look like eczema can happen during treatment with TALTZ from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with TALTZ if you develop severe skin reactions. […]

Source: FDA drug label, Eli Lilly and Company, effective January 22, 2026 (SPL set ac96658a-d7dc-4c7c-8928-2adcdf4318b2), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

Table 2: Adverse Reactions Occurring in ≥1% of the TALTZ Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12

Adverse ReactionsTALTZ 80 mg Q2W (N=1167) n (%)Etanercept b (N=287) n (%)Placebo (N=791) n (%)
Injection site reactions196 (17)32 (11)26 (3)
Upper respiratory tract infections a163 (14)23 (8)101 (13)
Nausea23 (2)1 (<1)5 (1)
Tinea infections17 (2)01 (<1)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse drug reactions are discussed in greater detail in other sections of the label: Infections [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Eczematous Eruptions [see Warnings and Precautions ( 5.4 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.5 )] Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 (1-800-LillyRx) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Plaque Psoriasis Weeks 0 to 12 : Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of TALTZ compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received TALTZ (160 mg at Week 0, 80 mg every 2 weeks [Q2W] for 12 weeks) subcutaneously. …

Source: FDA drug label, Eli Lilly and Company, effective January 22, 2026 (SPL set ac96658a-d7dc-4c7c-8928-2adcdf4318b2), via openFDA; the full label on DailyMed

What do FAERS reports show?

36,780 reports list ixekizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 547 are coded as a death and 2,990 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. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Injection Site Pain3,901
  • Psoriasis (a use or a product term, not a reaction)3,254
  • Drug Ineffective (a use or a product term, not a reaction)3,253
  • Injection Site Erythema2,200
  • Injection Site Reaction (named in the label)1,785
  • Injection Site Swelling1,650
  • Incorrect Dose Administered (a use or a product term, not a reaction)1,179
  • Product Dose Omission Issue (a use or a product term, not a reaction)947
  • Pain923
  • Covid-19921
  • Arthralgia888
  • Therapy Interrupted (a use or a product term, not a reaction)835
  • Rash (named in the label)830
  • Diarrhoea (named in the label)826
  • Pruritus801
  • Injection Site Pruritus796
  • Psoriatic Arthropathy791
  • Nausea (named in the label)768
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)677
  • Injection Site Urticaria670
  • Fatigue667
  • Nasopharyngitis (named in the label)645
  • Off Label Use (a use or a product term, not a reaction)622
  • Injection Site Mass615
  • Injection Site Haemorrhage613

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ixekizumab: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions