Enbrel

N/A

Manufactured by Immunex Corporation

1,364,746 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Enbrel

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

Top Adverse Reactions

DRUG INEFFECTIVE75,212 reports
INJECTION SITE PAIN56,701 reports
RHEUMATOID ARTHRITIS46,372 reports
ARTHRALGIA45,139 reports
PAIN43,197 reports
INJECTION SITE ERYTHEMA41,024 reports
FATIGUE30,417 reports
JOINT SWELLING25,550 reports
PAIN IN EXTREMITY25,531 reports
PSORIASIS25,031 reports
HEADACHE24,802 reports
INJECTION SITE SWELLING23,263 reports
OFF LABEL USE22,314 reports
INJECTION SITE PRURITUS22,093 reports
INJECTION SITE REACTION20,886 reports
NASOPHARYNGITIS20,725 reports
CONDITION AGGRAVATED20,648 reports
RASH20,200 reports
NAUSEA19,317 reports
MALAISE18,718 reports
DRUG INTOLERANCE16,729 reports
SINUSITIS16,544 reports
DRUG HYPERSENSITIVITY14,909 reports
MUSCULOSKELETAL STIFFNESS14,555 reports
ARTHROPATHY14,425 reports
ALOPECIA14,355 reports
PERIPHERAL SWELLING14,229 reports
HYPERSENSITIVITY14,015 reports
INJECTION SITE BRUISING13,738 reports
DIARRHOEA13,715 reports
INFECTION13,520 reports
PYREXIA13,289 reports
TREATMENT FAILURE13,128 reports
SWELLING12,936 reports
ABDOMINAL DISCOMFORT12,891 reports
CONTRAINDICATED PRODUCT ADMINISTERED12,791 reports
PNEUMONIA12,539 reports
COUGH12,504 reports
PRURITUS12,459 reports
DYSPNOEA11,963 reports
MOBILITY DECREASED11,308 reports
DRUG DOSE OMISSION11,157 reports
SYNOVITIS11,088 reports
PSORIATIC ARTHROPATHY10,918 reports
BACK PAIN10,854 reports
VOMITING10,820 reports
DIZZINESS10,506 reports
INJECTION SITE WARMTH10,382 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS10,046 reports
THERAPEUTIC PRODUCT EFFECT DECREASED9,789 reports
SYSTEMIC LUPUS ERYTHEMATOSUS9,735 reports
GAIT DISTURBANCE9,705 reports
HEPATIC ENZYME INCREASED9,644 reports
FALL9,135 reports
ASTHENIA8,953 reports
INJECTION SITE HAEMORRHAGE8,833 reports
ARTHRITIS8,805 reports
HAND DEFORMITY8,428 reports
PEMPHIGUS8,286 reports
MUSCULOSKELETAL PAIN8,173 reports
DRUG EFFECT INCOMPLETE8,086 reports
HYPERTENSION8,047 reports
WEIGHT INCREASED7,941 reports
CONTUSION7,905 reports
GLOSSODYNIA7,845 reports
URTICARIA7,826 reports
HYPOAESTHESIA7,741 reports
DRUG EFFECT DECREASED7,673 reports
INFLUENZA7,451 reports
INSOMNIA7,305 reports
LOWER RESPIRATORY TRACT INFECTION7,282 reports
THERAPEUTIC RESPONSE DECREASED7,247 reports
INFUSION RELATED REACTION7,205 reports
WOUND7,176 reports
ERYTHEMA7,101 reports
INJECTION SITE RASH7,098 reports
BRONCHITIS6,852 reports
PRODUCT USE ISSUE6,836 reports
IMPAIRED HEALING6,581 reports
ABDOMINAL PAIN UPPER6,580 reports
URINARY TRACT INFECTION6,435 reports
DISCOMFORT6,377 reports
ACCIDENTAL EXPOSURE TO PRODUCT6,365 reports
FEELING ABNORMAL6,359 reports
DEATH6,350 reports
INFLAMMATION6,205 reports
OROPHARYNGEAL PAIN6,074 reports
INJECTION SITE HAEMATOMA6,060 reports
GASTROINTESTINAL DISORDER6,012 reports
MATERNAL EXPOSURE DURING PREGNANCY6,004 reports
OSTEOARTHRITIS5,895 reports
BLISTER5,860 reports
WEIGHT DECREASED5,707 reports
PERICARDITIS5,696 reports
OEDEMA PERIPHERAL5,647 reports
STOMATITIS5,637 reports
PARAESTHESIA5,447 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE5,424 reports
JOINT STIFFNESS5,268 reports
GENERAL PHYSICAL HEALTH DETERIORATION5,207 reports

Report Outcomes

Out of 592,873 classified reports for Enbrel:

  • Serious: 213,113 reports (35.9%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 379,760 reports (64.1%)
Serious 35.9%Non-Serious 64.1%

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

Female408,599 (74.4%)
Male139,297 (25.4%)
Unknown1,013 (0.2%)

Reports by Age

Age 6012,759 reports
Age 5912,528 reports
Age 5812,504 reports
Age 6112,018 reports
Age 5711,876 reports
Age 5611,761 reports
Age 6311,641 reports
Age 5511,634 reports
Age 6211,501 reports
Age 5411,429 reports
Age 6411,428 reports
Age 5310,454 reports
Age 6510,299 reports
Age 5210,182 reports
Age 519,324 reports
Age 508,945 reports
Age 668,666 reports
Age 678,303 reports
Age 498,117 reports
Age 447,660 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 Enbrel?

This profile reflects 1,364,746 FDA FAERS reports that mention Enbrel. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Enbrel?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, INJECTION SITE PAIN, RHEUMATOID ARTHRITIS, ARTHRALGIA, PAIN, INJECTION SITE ERYTHEMA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Enbrel?

Labeling and FAERS entries often list Immunex Corporation in connection with Enbrel. 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 Enbrel:

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)

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Explore More

Safety RankingsSearch All DrugsCompare DrugsImmunex Corporation PortfolioDRUG INEFFECTIVE in Other DrugsINJECTION SITE PAIN in Other DrugsRHEUMATOID ARTHRITIS 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.