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Humira (Adalimumab) - Side Effect Reports to FDA

 
 



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 consumer/non-health professional from Lebanon on 2012-08-27

Patient: male

Reactions: Fatigue, Anaemia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Humira
    Indication: Crohn's Disease

Humira
    Indication: Ankylosing Spondylitis
    Start date: 2011-04-15

Other drugs received by patient: ONE Alfa; Calcium Carbonate; Bisoprolol Fumarate; Fosamax; Allopurinol; Amlodipine Besylate; Imuran; Cholchicine



Possible Humira side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male, weighing 53.7 kg (118.1 pounds)

Reactions: Brain Stem Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2008-09-11

Humira
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-08

Other drugs received by patient: Calcichew D3; Sodium Chloride; Azathioprine Sodium



Possible Humira side effects in male

Reported by a physician from Uruguay on 2012-08-27

Patient: male

Reactions: Colonic Polyp, Gastrointestinal Haemorrhage, Gastritis Erosive, Aortic Aneurysm, Haemorrhagic Anaemia, Thrombocytopenia

Drug(s) suspected as cause:
Humira
    Start date: 2012-05-05
    End date: 2012-08-07

Meloxicam
    Dosage: on demand
    Administration route: Oral
    Indication: Analgesic Therapy

Warfarin Sodium
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2007-08-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-09-12
    End date: 2012-03-02

Other drugs received by patient: Citalopram Hydrobromide; Methotrexate; Meloxicam



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 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 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 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 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 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

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