Contact us
Contact a member of the Novartis team for more information.
Image
Image
Cosentyx® (secukinumab): Psoriasis safety profile and side effects
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.1
In Ireland Cosentyx is reimbursed for the following indications: adult plaque psoriasis (PsO); psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).
Cosentyx has a consistent safety profile across indications, demonstrated by over a decade of clinical experience*1,2
*Since first indication in 2015 for eligible adults with moderate to severe plaque psoriasis.2
1.8 million+ patients treated globally†3
Image
No discontinuations in pooled clinical trial data and real-world evidence (RWE) due to Candida infections, with all being non-serious and mild to moderate in severity, except four cases in the PsO pool that were considered severe4
Image
No trend towards increased rates of major adverse cardiovascular event (MACE), malignancy or inflammatory bowel disease (IBD) reported over time in clinical trials or RWE5
Please read the full warnings and precautions (found in the SmPC) when prescribing Cosentyx.
RWE shows a consistent safety profile over 9 years in adult indications5
No trend towards increased adverse event (AE) rates over time (pooled data; AS, PsA and PsO in a PSUR including exposure in clinical trials and marketing experience).5
Image
Source: Novartis Data on File. 2025.5
Successive time periods of PSUR shown with cumulative rate: 26 Dec 2014 to 25 June 2015; 26 June 2015 to 25 Dec 2015; 26 Dec 2015 to 25 June 2016; 26 June 2016 to 25 Dec 2016; 26 Dec 2016 to 25 Dec 2017; 26 Dec 2017 to 25 Dec 2018; 26 Dec 2018 to 25 Dec 2019; 26 Dec 2019 to 25 Dec 2020; 26 Dec 2020 to 25 Dec 2023.5
Please refer to the SmPC for full safety information before prescribing.
Summary of AEs from clinical trials and post-marketing experience1
The most frequently reported AEs were upper respiratory tract infections (17.1%; most frequently nasopharyngitis, rhinitis). The safety profile is consistent across indications.1
Image
Adapted from Cosentyx SmPC.1
Please refer to the SmPC for full prescribing information and safety profile.1
Safety warnings and and precautions1
Image
Cosentyx is contraindicated in:
Patients with hypersensitivity to active substance or to any of the excipients
Patients with clinically important, active infection, e.g., active tuberculosis
Image
Patients should be evaluated for tuberculosis infection prior to initiating treatment with Cosentyx. Cosentyx should not be given to patients with active tuberculosis. In patients with latent tuberculosis, anti‑tuberculosis therapy should be considered prior to initiation of secukinumab as per clinical guidelines. Patients receiving Cosentyx should be monitored for signs and symptoms of active tuberculosis.
Image
Cases of new or exacerbations of inflammatory bowel disease (IBD) have been reported with Cosentyx. Cosentyx is not recommended in patients with IBD. If a patient develops signs or symptoms of IBD or experiences an exacerbation of pre-existing IBD, Cosentyx should be discontinued and appropriate medical management should be initiated.
Image
Cosentyx has the potential to increase the risk of infections. Serious infections have been observed in patients receiving Cosentyx in the post-marketing setting. Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and Cosentyx should not be administered until the infection resolves. Please see the SmPC for full information.
Image
Rare cases of anaphylactic reactions and angioedema have been observed in patients receiving Cosentyx. If an anaphylactic reaction, angioedema or other serious allergic reaction occurs, administration of Cosentyx should be discontinued immediately and appropriate therapy initiated.
Image
Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy. Because of the potential for adverse reactions in nursing infants from Cosentyx, a decision on whether to discontinue breastfeeding during treatment and up to 20 weeks after treatment, or to discontinue therapy with Cosentyx, must be made, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the woman.
Image
Live vaccinations should not be given concurrently with Cosentyx. Please see the SmPC for full information regarding vaccinations.
Image
The removable needle cap of Cosentyx 150 mg in pre-filled syringe and 150 mg pre-filled pen contains a derivative of natural rubber (latex). Use in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions which cannot be completely ruled out.
Image
In psoriasis studies, the safety and efficacy of Cosentyx in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. Cosentyx was administered concomitantly with methotrexate, sulfasalazine and/or corticosteroids in arthritis studies (including in patients with PsA and AS). Caution should be exercised when considering concomitant use of other immunosuppressants and Cosentyx.
Image
Hepatitis B virus (HBV) reactivation can occur in patients treated with Cosentyx. In accordance with clinical guidelines for immunosuppressants, testing patients for HBV infection is to be considered before initiating treatment with Cosentyx. Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation during Cosentyx treatment. If reactivation of HBV occurs while on Cosentyx, discontinuation of the treatment should be considered, and patients should be treated according to clinical guidelines.
Please refer to the SmPC for detailed safety profile data and full prescribing and administration information, including dosing in special populations and warnings/precautions.1
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Please refer to the Cosentyx SmPC for full product information before prescribing.1
†Across 8 indications.3
AE, adverse event; AS, ankylosing spondylitis; axSpA, non-radiographic axial spondyloarthritis; EAIR, exposure-adjusted incidence rate; ERA, enthesitis-related arthritis; HBV, hepatitis B virus; HLT, high-level term; HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; IGA, investigator global assessment; JPsA, juvenile psoriatic arthritis; MACE, major adverse cardiovascular event; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; NRS30, numeric rating scale 30; NMQ, Novartis MedDRA query; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; RWE, real-world evidence; SAE, serious adverse event; SmPC, summary of product characteristics; SMQ, standardised MedDRA queries; SOC, standard of care.
References
Cosentyx® (secukinumab) Summary of Product Characteristics. Available on www.medicines.ie.
European Medicines Agency. Summary of positive opinion EMA/CHMP/670/0627/2015. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cosentyx_en.pdf [Accessed March 2026].
Novartis quarterly financial results. Condensed Interim Financial Report – Supplementary Data. Available at: https://www.novartis.com/investors/financial-data/quarterly-results [Accessed March 2026].
Deodhar A, et al. Arthritis Res Ther 2019;21(1):111.
Novartis Data on File. Secukinumab (SEC020). April 2025.
IE11485250 | March 2026
