This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Humira (Adalimumab) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (31723)
Death (1425)
Life Threatening Events (513)
Disability (376)
Reports by Reaction Type
Injection Site Pain (3359),
Arthralgia (1933),
Drug Ineffective (1901),
Pain (1672),
Fatigue (1596),
Pyrexia (1505),
Psoriasis (1406),
Headache (1299),
Crohn's Disease (1201),
Nausea (1177),
Injection Site Erythema (1134),
Diarrhoea (1121)
Below are a few examples of reports where side effects / adverse reactions may be related to Humira (Adalimumab). For a complete list or a specific selection of reports, please use the links above.
Possible Humira side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27
Patient: male, weighing 77.0 kg (169.4 pounds)
Reactions: Angina Unstable
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Cyclosporine; Amlodipine; Cetirizine; Omeprazole; Metformin HCL; Acetaminophen / Hydrocodone Bitartrate; Aspirin; Nitroglycerin; Bisoprolol Fumarate; Simvastatin; Naproxen
Possible Humira side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-08-27
Patient: female, weighing 47.0 kg (103.4 pounds)
Reactions: Nerve Injury, Malaise, Lung Disorder, Pulmonary Tuberculosis, Sarcoidosis, Herpes Virus Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Methotrexate; Valifol; Prednisone TAB; Lyrica; Refina; Rifater
Possible Humira side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: male
Reactions: Cerebrovascular Accident, Transient Ischaemic Attack
Drug(s) suspected as cause:
Humira
Possible Humira side effects in male
Reported by a individual with unspecified qualification from United States on 2012-08-27
Patient: male
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female, weighing 61.3 kg (134.8 pounds)
Reactions: Injection Site Haematoma, Injection Site Pain, Headache, Anal Fissure, Injection Site Pruritus, Anal Fistula, Breech Presentation, Proctalgia, Injection Site Papule
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Probiotic; Imuran; Tylenol; Calcium + Vitamin D; Multi-Vitamins; Calcium Carbonate; Prednisone TAB; Multi-Vitamins; Caffeine Citrate; Azathioprine Sodium; Percocet; Ambien; Imuran; Prednisone TAB; Lialda; Folic Acid; Caffeine Citrate; Prednisone TAB; Tylenol; Ambien
Possible Humira side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Coronary Artery Occlusion, Arteriosclerosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Unknown Blood Pressure Medication; Unknown Cholesterol Medication
Possible Humira side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Iron Deficiency Anaemia, Rectal Haemorrhage, Large Intestinal Haemorrhage
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-08-27
Patient: female
Reactions: Back Pain, Intervertebral Disc Protrusion, Impaired Work Ability, Muscular Weakness, Hypertension, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Nootropil; Arluy; Trixilem; Dioban; Concord; Levothyroxine Sodium; Malibal Compuesto; Levothyroxine Sodium; Alzam; Nootropil; Clonazepam; Modiodam; Cartigen; Cymbalta; Lyrica; Fosfocil; Folic Acid; Toteye Secuencial
Possible Humira side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 90.8 kg (199.8 pounds)
Reactions: Vaginal Dysplasia, Vulvar Dysplasia, Vulval Cancer Stage II
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Plaquenil; Prozac; Mobic
Possible Humira side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: female, weighing 56.5 kg (124.3 pounds)
Reactions: Intestinal Perforation, Injection Site Erythema, Pain in Extremity, Injection Site Induration, Injection Site Warmth, Injection Site Swelling, Abortion Spontaneous
Drug(s) suspected as cause:
Humira
Start date: 2010-09-01
End date: 2010-09-01
Humira
Start date: 2010-09-01
End date: 2010-09-01
Humira
Indication: Crohn's Disease
Start date: 2010-09-01
Other drugs received by patient: Celestamine TAB
Possible Humira side effects in male
Reported by a physician from Germany on 2012-08-27
Patient: male, weighing 88.0 kg (193.6 pounds)
Reactions: Cirrhosis Alcoholic, Liver Function Test Abnormal
Drug(s) suspected as cause:
Humira
End date: 2012-05-02
Humira
Start date: 2009-11-01
End date: 2011-06-15
Humira
Indication: Psoriasis
Start date: 2012-01-05
End date: 2012-04-19
Other drugs received by patient: Dekristol
Possible Humira side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 62 year old female
Reactions: Allergic Oedema, Drug Tolerance Increased, Urticaria, Psoriasis, Musculoskeletal Discomfort, DRY Eye, Angle Closure Glaucoma
Drug(s) suspected as cause:
Zetia
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-13
Lotrel
Indication: Product Used FOR Unknown Indication
Humira
Indication: Psoriasis
Lipitor
Indication: Product Used FOR Unknown Indication
End date: 2012-07-01
Other drugs received by patient: Losartan Potassium; Potassium; Nopalea; Amlodipine; Carvedilol; Celexa
Possible Humira side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 58 year old female
Reactions: Abdominal Discomfort, Diarrhoea, Upper-Airway Cough Syndrome, Sneezing, Gallbladder Disorder, Headache, Sinusitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Folic Acid; Vitamin D; Procardia; Coumadin; Singulair; Potassium; Methotrexate; Lasix; Symbicort; Omeprazole
Possible Humira side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male, weighing 84.9 kg (186.8 pounds)
Reactions: Colitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Florastor; Ondansetron Hydrochloride; Effexor; Mercaptopurine; Mercaptopurine; Canasa; Rowasa; Allopurinol; Lialda; Cortifoam; Anamantle HC; Florastor; Xifaxan; Lialda
Possible Humira side effects in
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient:
Reactions: Craniosynostosis, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Humira
Possible Humira side effects in male
Reported by a physician from Japan on 2012-08-27
Patient: male
Reactions: Acne, Rotator Cuff Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Psoriasis
Start date: 2010-07-13
End date: 2010-07-13
Humira
Start date: 2011-03-18
Humira
Start date: 2010-07-28
End date: 2010-12-15
Other drugs received by patient: Maxacalcitol; Diflucortolone Valerate
Possible Humira side effects in 20 year old male
Reported by a physician from United States on 2012-08-27
Patient: 20 year old male
Reactions: Abdominal Pain, Drug Ineffective, Dehydration, Diarrhoea Haemorrhagic, Colitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Precancerous Skin Lesion, Rash
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Abdominal Pain, Fatigue, Diarrhoea, Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in 39 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 39 year old female
Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Injection Site Haematoma, Adverse Drug Reaction, False Positive Investigation Result, Joint Stiffness, Rheumatoid Arthritis, Malaise, Premature Rupture of Membranes, Umbilical Cord Around Neck, Amniotic Fluid Volume Decreased, Injection Site Induration, Breech Presentation, Drug Effect Decreased, Injection Site Pain, Hormone Level Abnormal, Lung Disorder, Arthralgia, Infertility
Drug(s) suspected as cause:
Methotrexate
Indication: Product Used FOR Unknown Indication
Humira
Start date: 2007-08-01
End date: 2008-12-01
Methotrexate
End date: 2012-08-10
Humira
Start date: 2009-08-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2007-01-01
Other drugs received by patient: Methotrexate; Hormone Injections; Zyrtec; Prednisone TAB; BCP; Nasonex; Generic FOR Prilosec; Albuterol; Semar
Possible Humira side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27
Patient: male, weighing 108.0 kg (237.6 pounds)
Reactions: Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Steroids; Methotrexate
Possible Humira side effects in female
Reported by a physician from Japan on 2012-08-27
Patient: female, weighing 49.3 kg (108.5 pounds)
Reactions: Abdominal Pain, Subileus, Pyrexia, Peritonitis, Gastrointestinal Anastomotic Leak, Postoperative Ileus, Intestinal Mucosal Hypertrophy, Fistula Discharge, Gastrointestinal Oedema, Abscess, Small Intestinal Stenosis, Purulent Discharge, Fluid Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Start date: 2010-11-30
End date: 2010-11-30
Humira
Start date: 2010-12-28
End date: 2011-03-08
Humira
Start date: 2010-12-14
End date: 2010-12-14
Other drugs received by patient: Mesalamine; Dimeticone; Pyridoxal Phosphate Hydrate; Rebamipide; Magnesium Oxide; Loxoprofen Sodium Hydrate; Flavin Adenine Dinucleotide
Possible Humira side effects in male
Reported by a consumer/non-health professional from Germany on 2012-08-27
Patient: male
Reactions: Multi-Organ Failure, Intestinal Operation, Sepsis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 55.4 kg (121.9 pounds)
Reactions: Nasal Turbinate Abnormality, Injection Site Erythema, Incorrect Dose Administered, Injection Site Pain, Nasal Septum Deviation, Injection Site Papule
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Areva ONE; Vitamin D; Lysine; Lysine; Prilosec; Birth Control Pills
Possible Humira side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male, weighing 135.0 kg (297.1 pounds)
Reactions: Dyspnoea, Pleurisy, Lung Neoplasm, Psoriasis, Headache, Pyrexia, Fatigue, Chest Pain, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Psoriasis
Start date: 2011-11-01
End date: 2012-01-01
Humira
Start date: 2012-08-01
Other drugs received by patient: Clonazepam; Nexium; Invega; Cogentin; Lexapro; Buspar; Seroquel
Possible Humira side effects in male
Reported by a physician from Slovenia on 2012-08-27
Patient: male, weighing 101.0 kg (222.2 pounds)
Reactions: Multi-Organ Failure, Pneumonia Legionella, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Infliximetan
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-14
End date: 2011-06-12
Humira
Indication: Ankylosing Spondylitis
Start date: 2010-10-14
End date: 2012-07-25
Other drugs received by patient: Arcoxia
Possible Humira side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: 53 year old male
Reactions: Aesthesioneuroblastoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Remicade
Dosage: 3 mg/kg, single
Indication: Ankylosing Spondylitis
Start date: 2011-03-23
End date: 2011-04-07
Humira
Dosage: 40 mg, every other week
Indication: Ankylosing Spondylitis
Start date: 2006-10-01
End date: 2011-02-18
Enbrel
Dosage: 50 mg, weekly
Indication: Ankylosing Spondylitis
Start date: 2005-11-01
End date: 2006-05-01
Possible Humira side effects in female
Reported by a physician from Canada on 2012-08-27
Patient: female
Reactions: Bone Cyst, Pain in Extremity, Oedema Peripheral, Cyst
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2012-02-04
Humira
End date: 2012-08-09
Possible Humira side effects in 67 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 67 year old male
Reactions: Haemoglobin Decreased, Nasopharyngitis, Cough
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Iron; Prednisone TAB
Possible Humira side effects in 43 year old male
Reported by a physician from Brazil on 2012-08-27
Patient: 43 year old male
Reactions: Ischaemic Stroke
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
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