What the label lists and what reports show
Secukinumab side effects
Secukinumab's FDA label: “Most common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.” FAERS holds 160,421 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 pain (16,628 reports).
- No generic listed
Check it at the source: the secukinumab FDA label on DailyMed (effective August 25, 2026, Novartis Pharmaceuticals Corporation); 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 COSENTYX?COSENTYX may cause serious side effects, including: See “What is the most important information I should know about COSENTYX?” Serious allergic reactions. 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 ◦ hives (red, itchy bumps) If you have a serious allergic reaction, do not give another injection of COSENTYX. Inflammatory bowel disease. New cases of inflammatory bowel disease or “flare-ups” can happen with COSENTYX and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your healthcare provider if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 25, 2026 (SPL set 77c4b13e-7df3-42d4-81db-3d0cddb7f67a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.
Table 2: Adverse Reactions Reported by Greater Than 1% of Adult Subjects With PsO (and at a Higher Rate in Subjects Treated with COSENTYX) Through Week 12 in Trials PsO1, PsO2, PsO3, and PsO4
| Adverse reactions | 300 mg (N = 691) n (%) | 150 mg (N = 692) n (%) | Placebo (N = 694) n (%) |
|---|---|---|---|
| Nasopharyngitis | 79 (11.4) | 85 (12.3) | 60 (8.6) |
| Diarrhea | 28 (4.1) | 18 (2.6) | 10 (1.4) |
| Upper respiratory tract infection | 17 (2.5) | 22 (3.2) | 5 (0.7) |
| Rhinitis | 10 (1.4) | 10 (1.4) | 5 (0.7) |
| Oral herpes | 9 (1.3) | 1 (0.1) | 2 (0.3) |
| Pharyngitis | 8 (1.2) | 7 (1.0) | 0 (0) |
| Urticaria | 4 (0.6) | 8 (1.2) | 1 (0.1) |
| Rhinorrhea | 8 (1.2) | 2 (0.3) | 1 (0.1) |
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, continuedThe following adverse reactions are discussed in greater detail elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Inflammatory Bowel Disease [see Warnings and Precautions (5.4)] Eczematous Eruptions [see Warnings and Precautions (5.5)] Most common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 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. Adverse Reactions in Clinical Trials of Subcutaneous COSENTYX Adverse Reactions from Clinical Trials in Adults with PsO A total of 3,430 adult subjects with PsO were treated with COSENTYX in controlled and uncontrolled clinical trials. Of these, 1,641 subjects were treated with COSENTYX for at least 1 year. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 25, 2026 (SPL set 77c4b13e-7df3-42d4-81db-3d0cddb7f67a), via openFDA; the full label on DailyMed
What do FAERS reports show?
160,421 reports list secukinumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8,611 are coded as a death and 21,920 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 20 reactions below, 7 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Secukinumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions