In the Arava prescribing information, the following adverse reactions
have been reported in the controlled studies performed on the rheumatoid
arthritis drug, regardless of causality.
Body as a whole: allergic reaction, asthenia, flu syndrome,
infection, injury accident, pain, abdominal pain, back pain, abscess,
cyst, fever, hernia, malaise, pain, neck pain, pelvic pain
Cardiovascular: hypertension, chest pain, angina pectoris,
migraine, palpitation, tachycardia, varicose vein, vasculitis,
vasodilatation
Gastrointestinal: anorexia, diarrhea, dyspepsia, gastroenteritis,
abnormal liver enzymes, nausea, GI/abdominal pain, mouth ulcer,
vomiting, cholelithiasis, colitis, constipation, esophagitis,
flatulence, gastritis, gingivitis, melena, oral moniliasis, pharyngitis,
salivary gland enlarged, stomatitis, tooth disorder
Endocrine: diabetes mellitus, hyperthyroidism
Hemic and lympathic system: anemia, ecchymosis
Metabolic and nutritional: hypokalemia, weight loss, creatine
phosphokinase increased, hyperglycemia, hyperlipidemia, peripheral
edema
Musculo-skeletal system: arthralgia, leg cramps, joint
disorder, synovitis, tenosynovitis, arthrosis, bone necrosis,
bone pain, bursitis, muscle cramps, myalgia, tendon rupture
Nervous system: dizziness, headache, paresthesia, anxiety,
depression, dry mouth, insomnia, neuralgia, neuritis, sleep disorder,
sweating increased, vertigo
Respiratory system: bronchitis, increased cough, respiratory
infection, pharyngitis, pneumonia, rhinitis, sinusitis, asthma,
dyspnea, epistaxis, lung disorder
Skin and appendages: alopecia, eczema, pruritus, rash,
dry skin, acne, contact dermatitis, fungal dermatitis, hair discoloration,
hematoma, herpes simplex, herpes zoster, maculopapular rash, nail
disorder, skin discoloration, skin disorder, skin nodule, subcutaneous
nodule, ulcer skin
Special senses: blurred vision, cataract, conjunctivitis,
eye disorder, taste perversion
Urogenital system: urinary tract infection, albuminuria,
cystitis, dysuria, hematuria, menstrual disorder, prostate disorder,
urinary frequency, vaginal moniliasis