Humira

N/A

Manufactured by AbbVie Inc.

1,495,215 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Humira

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

Top Adverse Reactions

DRUG INEFFECTIVE91,120 reports
PAIN49,351 reports
ARTHRALGIA48,309 reports
INJECTION SITE PAIN47,302 reports
FATIGUE39,342 reports
RHEUMATOID ARTHRITIS35,785 reports
HEADACHE28,557 reports
NAUSEA27,276 reports
DIARRHOEA25,615 reports
RASH25,502 reports
PSORIASIS24,818 reports
PAIN IN EXTREMITY24,453 reports
JOINT SWELLING23,449 reports
INCORRECT DOSE ADMINISTERED22,347 reports
MALAISE21,522 reports
OFF LABEL USE21,369 reports
NASOPHARYNGITIS20,735 reports
CROHN^S DISEASE19,769 reports
PYREXIA19,166 reports
DEVICE ISSUE18,060 reports
DRUG INTOLERANCE17,334 reports
ALOPECIA16,836 reports
VOMITING16,590 reports
CONDITION AGGRAVATED16,536 reports
INJECTION SITE HAEMORRHAGE16,168 reports
ABDOMINAL PAIN15,795 reports
PNEUMONIA15,684 reports
DYSPNOEA15,646 reports
PERIPHERAL SWELLING15,337 reports
INJECTION SITE ERYTHEMA15,205 reports
DIZZINESS14,768 reports
PRURITUS14,623 reports
INFECTION14,487 reports
FALL14,361 reports
ABDOMINAL DISCOMFORT14,258 reports
MUSCULOSKELETAL STIFFNESS13,888 reports
SINUSITIS13,787 reports
ARTHROPATHY13,755 reports
ASTHENIA13,701 reports
BACK PAIN13,560 reports
SYSTEMIC LUPUS ERYTHEMATOSUS13,520 reports
DRUG HYPERSENSITIVITY13,323 reports
HYPERSENSITIVITY13,248 reports
SWELLING13,110 reports
WEIGHT DECREASED12,793 reports
THERAPEUTIC PRODUCT EFFECT DECREASED12,452 reports
COUGH12,431 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS12,157 reports
DEATH12,153 reports
CONTRAINDICATED PRODUCT ADMINISTERED11,989 reports
TREATMENT FAILURE11,722 reports
HYPERTENSION11,606 reports
ARTHRITIS11,388 reports
SYNOVITIS11,264 reports
GAIT DISTURBANCE11,205 reports
PSORIATIC ARTHROPATHY10,911 reports
MOBILITY DECREASED10,834 reports
HEPATIC ENZYME INCREASED10,632 reports
OSTEOARTHRITIS10,498 reports
HYPOAESTHESIA10,466 reports
WEIGHT INCREASED10,346 reports
ABDOMINAL PAIN UPPER10,119 reports
INJECTION SITE BRUISING10,099 reports
INFLAMMATION9,674 reports
INJECTION SITE PRURITUS9,646 reports
COVID 199,295 reports
PEMPHIGUS9,089 reports
INSOMNIA8,947 reports
URINARY TRACT INFECTION8,708 reports
GLOSSODYNIA8,681 reports
URTICARIA8,638 reports
WOUND8,591 reports
HAND DEFORMITY8,344 reports
MATERNAL EXPOSURE DURING PREGNANCY8,332 reports
DEPRESSION8,259 reports
DRUG DOSE OMISSION8,215 reports
INFUSION RELATED REACTION8,090 reports
DECREASED APPETITE8,063 reports
ANXIETY8,018 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE7,908 reports
INJECTION SITE SWELLING7,837 reports
GASTROINTESTINAL DISORDER7,801 reports
DISCOMFORT7,769 reports
CONTUSION7,608 reports
COLITIS ULCERATIVE7,540 reports
INFLUENZA7,511 reports
PARAESTHESIA7,498 reports
CHEST PAIN7,486 reports
IMPAIRED HEALING7,456 reports
PRODUCT USE ISSUE7,382 reports
INJECTION SITE REACTION7,313 reports
ERYTHEMA7,306 reports
GENERAL PHYSICAL HEALTH DETERIORATION7,288 reports
MUSCLE SPASMS7,142 reports
FEELING ABNORMAL6,949 reports
INTESTINAL OBSTRUCTION6,779 reports
MUSCULOSKELETAL PAIN6,501 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES6,489 reports
OROPHARYNGEAL PAIN6,329 reports
PERICARDITIS6,301 reports

Report Outcomes

Out of 699,241 classified reports for Humira:

  • Serious: 355,120 reports (50.8%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 344,121 reports (49.2%)
Serious 50.8%Non-Serious 49.2%

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

Female448,464 (67.8%)
Male210,758 (31.9%)
Unknown1,947 (0.3%)

Reports by Age

Age 609,404 reports
Age 599,214 reports
Age 589,132 reports
Age 578,849 reports
Age 618,768 reports
Age 638,738 reports
Age 548,732 reports
Age 568,723 reports
Age 558,705 reports
Age 628,695 reports
Age 538,602 reports
Age 528,204 reports
Age 658,032 reports
Age 648,029 reports
Age 437,863 reports
Age 447,775 reports
Age 517,693 reports
Age 507,634 reports
Age 666,991 reports
Age 496,877 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 Humira?

This profile reflects 1,495,215 FDA FAERS reports that mention Humira. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Humira?

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

Who manufactures Humira?

Labeling and FAERS entries often list AbbVie Inc. in connection with Humira. Always verify the specific product and NDC with your pharmacist.

Other Drugs by AbbVie Inc.

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Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with Humira:

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

Safety RankingsSearch All DrugsCompare DrugsAbbVie Inc. PortfolioDRUG INEFFECTIVE in Other DrugsPAIN in Other DrugsARTHRALGIA 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.