pain 6% 4%
Urinary tract infection 8% 5%
Hypertension 5% 3%
* Laboratory test abnormalities were reported as adverse reactions in European trials
** Does not include injection site erythema, itching, hemorrhage, pain or swelling
Less Common Adverse Reactions in Rheumatoid Arthritis Clinical Studies
Other infrequent serious adverse reactions that do not appear in the Warnings and Precautions or Adverse Reaction sections that occurred at an incidence of less than 5% in Humira-treated patients in RA studies were:
Body As A Whole: Pain in extremity, pelvic pain, surgery, thorax pain
Cardiovascular System: Arrhythmia, atrial fibrillation, chest pain, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia
Digestive System: Cholecystitis, cholelithiasis, esophagitis, gastroenteritis, gastrointestinal hemorrhage, hepatic necrosis, vomiting
Endocrine System: Parathyroid disorder
Hemic And Lymphatic System: Agranulocytosis, polycythemia
Metabolic And Nutritional Disorders: Dehydration, healing abnormal, ketosis, paraproteinemia, peripheral edema
Musculo-Skeletal System: Arthritis, bone disorder, bone fracture (not spontaneous), bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder
Neoplasia: Adenoma
Nervous System: Confusion, paresthesia, subdural hematoma, tremor
Respiratory System: Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion
Special Senses: Cataract
Thrombosis: Thrombosis leg
Urogenital System: Cystitis, kidney calculus, menstrual disorder
Juvenile Idiopathic Arthritis Clinical Studies
In general, the adverse reactions in the Humira-treated pediatric patients in the juvenile idiopathic arthritis (JIA) trial were similar in frequency and type to those seen in adult patients [see Warnings and Precautions (5), Adverse Reactions (6)]. Important findings and differences from adults are discussed in the following paragraphs.
Humira was studied in 171 pediatric patients, 4 to 17 years of age, with polyarticular JIA. Severe adverse reactions reported in the study included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, appendicitis. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment with Humira and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster.
A total of 45% of children experienced an infection while receiving Humira with or without concomitant MTX in the first 16 weeks of treatment. The types of infections reported in Humira-treated patients were generally similar to those commonly seen in JIA patients who are not treated with TNF blockers. Upon initiation of treatment, the most common adverse reactions occurring in the pediatric population treated with Humira were injection site pain and injection site reaction (19% and 16%, respectively). A less commonly reported adverse event in children receiving Humira was granuloma annulare which did not lead to discontinuation of Humira treatment.
In the first 48 weeks of treatment, non-serious hypersensitivity reactions were seen in approximately 6% of children and included |
