Cosentyx

N/A

Manufactured by Novartis Pharmaceuticals Corporation

494,338 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Cosentyx

Cosentyx is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for Cosentyx include DRUG INEFFECTIVE, PSORIASIS, PAIN, ARTHRALGIA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Cosentyx.

Top Adverse Reactions

DRUG INEFFECTIVE28,950 reports
PSORIASIS22,709 reports
PAIN16,387 reports
ARTHRALGIA14,685 reports
FATIGUE10,379 reports
PSORIATIC ARTHROPATHY9,987 reports
PRURITUS9,301 reports
MALAISE9,286 reports
RASH8,890 reports
CONDITION AGGRAVATED8,349 reports
DIARRHOEA7,840 reports
NASOPHARYNGITIS7,647 reports
PAIN IN EXTREMITY7,208 reports
HEADACHE7,101 reports
OFF LABEL USE6,547 reports
JOINT SWELLING6,468 reports
MUSCULOSKELETAL STIFFNESS6,267 reports
NAUSEA6,211 reports
PERIPHERAL SWELLING5,391 reports
PYREXIA5,331 reports
ABDOMINAL DISCOMFORT5,161 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE5,054 reports
PNEUMONIA5,001 reports
HYPERSENSITIVITY5,000 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION4,940 reports
ALOPECIA4,880 reports
RHEUMATOID ARTHRITIS4,880 reports
PRODUCT DOSE OMISSION ISSUE4,778 reports
SWELLING4,755 reports
DYSPNOEA4,667 reports
INFECTION4,630 reports
INCORRECT DOSE ADMINISTERED4,593 reports
VOMITING4,496 reports
DRUG INTOLERANCE4,470 reports
ARTHROPATHY4,428 reports
ARTHRITIS4,320 reports
BACK PAIN4,281 reports
SINUSITIS4,241 reports
TREATMENT FAILURE4,208 reports
DIZZINESS4,194 reports
COUGH4,115 reports
LOWER RESPIRATORY TRACT INFECTION4,106 reports
HYPERTENSION4,093 reports
INFLAMMATION3,993 reports
COVID 193,991 reports
SYSTEMIC LUPUS ERYTHEMATOSUS3,983 reports
WOUND3,959 reports
SYNOVITIS3,936 reports
MOBILITY DECREASED3,919 reports
URTICARIA3,879 reports
PRODUCT USE IN UNAPPROVED INDICATION3,827 reports
GENERAL PHYSICAL HEALTH DETERIORATION3,826 reports
ASTHENIA3,803 reports
GLOSSODYNIA3,756 reports
HYPOAESTHESIA3,673 reports
PEMPHIGUS3,634 reports
ABDOMINAL PAIN UPPER3,590 reports
DRUG HYPERSENSITIVITY3,586 reports
GAIT DISTURBANCE3,545 reports
INJECTION SITE PAIN3,531 reports
WEIGHT INCREASED3,515 reports
HEPATIC ENZYME INCREASED3,496 reports
PRODUCT USE ISSUE3,466 reports
MATERNAL EXPOSURE DURING PREGNANCY3,464 reports
HAND DEFORMITY3,461 reports
DISCOMFORT3,440 reports
BLISTER3,420 reports
FIBROMYALGIA3,360 reports
THERAPEUTIC PRODUCT EFFECT DECREASED3,250 reports
INSOMNIA3,203 reports
PERICARDITIS3,153 reports
INFLUENZA3,127 reports
TYPE 2 DIABETES MELLITUS3,096 reports
SKIN EXFOLIATION3,083 reports
INFUSION RELATED REACTION3,076 reports
CONTRAINDICATED PRODUCT ADMINISTERED3,048 reports
CONFUSIONAL STATE3,041 reports
LIVER INJURY3,024 reports
GASTROINTESTINAL DISORDER2,980 reports
STOMATITIS2,920 reports
ERYTHEMA2,909 reports
INJURY2,879 reports
HELICOBACTER INFECTION2,877 reports
OSTEOARTHRITIS2,860 reports
DUODENAL ULCER PERFORATION2,850 reports
FOLLICULITIS2,841 reports
BLOOD CHOLESTEROL INCREASED2,805 reports
WEIGHT DECREASED2,792 reports
IRRITABLE BOWEL SYNDROME2,781 reports
DECREASED APPETITE2,772 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE2,764 reports
ACCIDENTAL EXPOSURE TO PRODUCT2,730 reports
FALL2,719 reports
IMPAIRED HEALING2,706 reports
DEPRESSION2,675 reports
WHEEZING2,670 reports
GAIT INABILITY2,661 reports
C REACTIVE PROTEIN INCREASED2,649 reports
ILLNESS2,578 reports
ANXIETY2,541 reports

Report Outcomes

Out of 158,730 classified reports for Cosentyx:

  • Serious: 63,120 reports (39.8%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 95,610 reports (60.2%)
Serious 39.8%Non-Serious 60.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female91,447 (62.1%)
Male55,771 (37.9%)
Unknown10 (0.0%)

Reports by Age

Age 432,952 reports
Age 442,377 reports
Age 402,212 reports
Age 591,898 reports
Age 581,797 reports
Age 561,771 reports
Age 541,702 reports
Age 611,694 reports
Age 601,688 reports
Age 571,671 reports
Age 621,643 reports
Age 501,627 reports
Age 551,599 reports
Age 631,574 reports
Age 521,572 reports
Age 531,540 reports
Age 511,500 reports
Age 491,461 reports
Age 481,429 reports
Age 651,361 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Cosentyx?

This profile reflects 494,338 FDA FAERS reports that mention Cosentyx. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Cosentyx?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PSORIASIS, PAIN, ARTHRALGIA, FATIGUE, PSORIATIC ARTHROPATHY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Cosentyx?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with Cosentyx. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with Cosentyx:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABATACEPT (78/100)ABEMACICLIB (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 500 MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)

View all drugs reporting DRUG INEFFECTIVE →

Explore More

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Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.