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secukinumab Side Effects

Also known as: Cosentyx

Analysis of 157,236 adverse event reports submitted to the FDA from 2012 to 2025.

Total Reports

157,236

Death-Related

7,752

4.9% of reports

Hospitalizations

20,636

13.1% of reports

Top Indication

Psoriasis

Most Reported Adverse Reactions

DRUG INEFFECTIVE
28,717
PSORIASIS
22,567
PAIN
16,136
ARTHRALGIA
14,488
FATIGUE
10,192
PSORIATIC ARTHROPATHY
9,805
PRURITUS
9,168
MALAISE
9,100
RASH
8,709
CONDITION AGGRAVATED
8,206
DIARRHOEA
7,681
NASOPHARYNGITIS
7,487
PAIN IN EXTREMITY
7,099
HEADACHE
6,938
OFF LABEL USE
6,356
JOINT SWELLING
6,317
MUSCULOSKELETAL STIFFNESS
6,143
NAUSEA
6,090
PERIPHERAL SWELLING
5,255
PYREXIA
5,177

Who Reports Side Effects

Gender Distribution

Female 90,501 (62%)
Male 55,361 (38%)
Unknown 10

Age Distribution

0-17 480 (1%)
18-44 19,834 (31%)
45-64 30,760 (49%)
65-74 8,814 (14%)
75+ 3,233 (5%)

Reporting Trend by Year

12
13
14
15
16
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 7,752 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 2,376
OFF LABEL USE 2,187
SYSTEMIC LUPUS ERYTHEMATOSUS 2,110
PSORIATIC ARTHROPATHY 2,092
TYPE 2 DIABETES MELLITUS 2,053
SYNOVITIS 2,047
GENERAL PHYSICAL HEALTH DETERIORATION 2,039
HYPOAESTHESIA 2,035
GLOSSODYNIA 2,032
RASH 2,026
RHEUMATOID ARTHRITIS 2,015
FIBROMYALGIA 1,992
SWELLING 1,990
WOUND 1,985
FATIGUE 1,984
HAND DEFORMITY 1,981
JOINT SWELLING 1,961
FOLLICULITIS 1,945
HYPERTENSION 1,915
DUODENAL ULCER PERFORATION 1,905

Reactions in Hospitalization Reports

Top reactions in 20,636 reports where hospitalization was an outcome.

Reaction Reports
PAIN 4,036
FATIGUE 3,589
ARTHRALGIA 3,559
MALAISE 3,362
DRUG INEFFECTIVE 3,258
PSORIATIC ARTHROPATHY 3,086
OFF LABEL USE 3,063
DIARRHOEA 2,916
RASH 2,913
JOINT SWELLING 2,850
HEADACHE 2,835
PYREXIA 2,757
VOMITING 2,727
RHEUMATOID ARTHRITIS 2,723
PNEUMONIA 2,622
CONDITION AGGRAVATED 2,618
GENERAL PHYSICAL HEALTH DETERIORATION 2,602
SWELLING 2,577
NAUSEA 2,559
PERIPHERAL SWELLING 2,526

Nearby — Related Medications

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What the FAERS Data Reveals About secukinumab Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 157,236 voluntary reports linked to secukinumab and its brand equivalents (Cosentyx), spanning 2012 through 2025. Of those, 7,752 (4.9%) listed death as an outcome and 20,636 (13.1%) involved hospitalization. The most common indication reported alongside adverse events was Psoriasis.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 62% were female and 38% male; age distribution skews toward 45-64, with 30,760 reports in that bracket. The single most reported reaction is drug ineffective with 28,717 submissions, followed by psoriasis and pain.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.