Otezla

N/A

Manufactured by Amgen, Inc

377,221 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Otezla

Otezla is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. The most commonly reported adverse reactions for Otezla include DIARRHOEA, NAUSEA, PSORIASIS, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Otezla.

Top Adverse Reactions

DIARRHOEA24,445 reports
NAUSEA22,018 reports
PSORIASIS20,366 reports
HEADACHE17,784 reports
DRUG INEFFECTIVE15,439 reports
ABDOMINAL DISCOMFORT8,145 reports
PSORIATIC ARTHROPATHY7,958 reports
PAIN6,733 reports
RASH6,607 reports
VOMITING6,427 reports
ARTHRALGIA6,317 reports
FATIGUE6,112 reports
DEPRESSION5,488 reports
OFF LABEL USE5,148 reports
WEIGHT DECREASED4,992 reports
ABDOMINAL PAIN UPPER4,823 reports
PRODUCT DOSE OMISSION ISSUE4,767 reports
PRODUCT DOSE OMISSION4,594 reports
MALAISE4,558 reports
PRURITUS4,225 reports
DECREASED APPETITE3,823 reports
CONDITION AGGRAVATED3,774 reports
THERAPY NON RESPONDER3,726 reports
DIZZINESS3,380 reports
INSOMNIA3,322 reports
JOINT SWELLING3,311 reports
ADVERSE DRUG REACTION3,309 reports
NASOPHARYNGITIS3,278 reports
ALOPECIA3,248 reports
RHEUMATOID ARTHRITIS3,239 reports
HYPERTENSION3,049 reports
DRUG INTOLERANCE2,958 reports
PAIN IN EXTREMITY2,940 reports
GASTROINTESTINAL DISORDER2,938 reports
ARTHROPATHY2,919 reports
INFECTION2,899 reports
HYPERSENSITIVITY2,884 reports
SYNOVITIS2,883 reports
MUSCULOSKELETAL STIFFNESS2,799 reports
GENERAL PHYSICAL HEALTH DETERIORATION2,781 reports
HYPOAESTHESIA2,665 reports
PERIPHERAL SWELLING2,659 reports
PNEUMONIA2,543 reports
THERAPEUTIC PRODUCT EFFECT DECREASED2,543 reports
HEPATIC ENZYME INCREASED2,542 reports
INFUSION RELATED REACTION2,517 reports
TREATMENT FAILURE2,509 reports
DRUG DOSE OMISSION2,500 reports
SYSTEMIC LUPUS ERYTHEMATOSUS2,498 reports
MOBILITY DECREASED2,497 reports
SWELLING2,496 reports
DRUG HYPERSENSITIVITY2,461 reports
DYSPEPSIA2,440 reports
MIGRAINE2,434 reports
SINUSITIS2,433 reports
WOUND2,410 reports
DYSPNOEA2,386 reports
GLOSSODYNIA2,386 reports
URTICARIA2,381 reports
TYPE 2 DIABETES MELLITUS2,348 reports
HAND DEFORMITY2,335 reports
DISCOMFORT2,330 reports
WEIGHT INCREASED2,201 reports
ASTHENIA2,200 reports
MUSCLE SPASMS2,190 reports
BLOOD CHOLESTEROL INCREASED2,183 reports
FIBROMYALGIA2,180 reports
PERICARDITIS2,155 reports
PEMPHIGUS2,129 reports
BLISTER2,114 reports
RHEUMATIC FEVER2,090 reports
DUODENAL ULCER PERFORATION2,063 reports
HELICOBACTER INFECTION2,051 reports
MEMORY IMPAIRMENT2,051 reports
ANXIETY2,026 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE2,019 reports
FOLLICULITIS1,989 reports
INJURY1,984 reports
PYREXIA1,984 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE1,984 reports
IRRITABLE BOWEL SYNDROME1,964 reports
STOMATITIS1,943 reports
CONFUSIONAL STATE1,911 reports
SLEEP DISORDER1,909 reports
IMPAIRED HEALING1,891 reports
WHEEZING1,843 reports
INFLAMMATION1,830 reports
ABDOMINAL PAIN1,826 reports
OSTEOARTHRITIS1,769 reports
MATERNAL EXPOSURE DURING PREGNANCY1,714 reports
CONTRAINDICATED PRODUCT ADMINISTERED1,703 reports
RHEUMATOID FACTOR POSITIVE1,697 reports
PRODUCT USE ISSUE1,681 reports
C REACTIVE PROTEIN INCREASED1,670 reports
LIVER INJURY1,664 reports
PRODUCT USE IN UNAPPROVED INDICATION1,626 reports
DRY MOUTH1,613 reports
JOINT RANGE OF MOTION DECREASED1,560 reports
UPPER RESPIRATORY TRACT INFECTION1,553 reports
ARTHRITIS1,542 reports

Report Outcomes

Out of 144,020 classified reports for Otezla:

  • Serious: 33,444 reports (23.2%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 110,576 reports (76.8%)
Serious 23.2%Non-Serious 76.8%

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

Female90,918 (66.1%)
Male46,535 (33.9%)
Unknown12 (0.0%)

Reports by Age

Age 592,724 reports
Age 432,443 reports
Age 562,437 reports
Age 622,377 reports
Age 602,331 reports
Age 632,329 reports
Age 582,327 reports
Age 612,323 reports
Age 542,270 reports
Age 572,259 reports
Age 552,248 reports
Age 642,070 reports
Age 442,056 reports
Age 501,970 reports
Age 531,955 reports
Age 401,921 reports
Age 521,893 reports
Age 511,810 reports
Age 651,715 reports
Age 491,632 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 Otezla?

This profile reflects 377,221 FDA FAERS reports that mention Otezla. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Otezla?

Frequently reported terms in FAERS include DIARRHOEA, NAUSEA, PSORIASIS, HEADACHE, DRUG INEFFECTIVE, ABDOMINAL DISCOMFORT. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Otezla?

Labeling and FAERS entries often list Amgen, Inc in connection with Otezla. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to DIARRHOEA

The following drugs share commonly reported adverse reactions with Otezla:

0XYGEN (75/100)ABEMACICLIB (78/100)ABIRATERONE ACETATE (72/100)ACALABRUTINIB (78/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 325MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE PHOSPHATE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)ACETAMINOPHEN, ASPIRIN, AND CAFFEINE (25/100)ACETAMINOPHEN, ASPIRIN, CAFFEINE (45/100)

View all drugs reporting DIARRHOEA →

Explore More

Safety RankingsSearch All DrugsCompare DrugsAmgen, Inc PortfolioDIARRHOEA in Other DrugsNAUSEA in Other DrugsPSORIASIS in Other Drugs
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.