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NEORAL (CYCLOSPORINE) CAPSULES AND ORAL SOLUTION: SIDE EFFECTS / ADVERSE REACTIONS FOR RHEUMATOID ARTHRITIS

The principal adverse reactions associated with the use of Cyclosporine (Neoral) in rheumatoid arthritis are renal dysfunction, headache, hypertension, gastrointestinal disturbances, hirsutism/hypertrichosis.

In rheumatoid arthritis patients treated in clinical trials within the recommended dose range, cyclosporine therapy was discontinued in 5.3% of the patients because of hypertension and in 7% of the patients because of increased creatinine. These changes are usually reversible with timely dose decrease or drug discontinuation. The frequency and severity of serum creatinine elevations increase with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced without dose reduction or discontinuation.

The following adverse events occurred in controlled clinical trials:

Autonomic Nervous System Disorders: flushing

Body as a Whole / General Disorders: accidental trauma, edema, fatigue, fever, influenza-like symptoms, pain, rigors

Cardiovascular Disorders: arrhythmia, chest pain, hypertension

Central and Peripheral Nervous System Disorders: dizziness, headache, migraine, paresthesia, tremor

Gastrointestinal System Disorders: abdominal pain, anorexia, diarrhea, dyspepsia, flatulence, gastrointestinal disorder, gingivitis, gum hyperplasia, nausea, rectal hemorrhage, stomatitis, vomiting

Hearing and Vestibular Disorders: ear disorder

Metabolic and Nutritional Disorders: hypomagnesemia

Musculoskeletal System Disorders: arthropathy, leg cramps / involuntary muscle contractions

Psychiatric Disorders: depression, insomnia

Renal: creatinine elevations

Reproductive Disorders (Female): leukorrhea, menstrual disorder

Respiratory System Disorders: bronchitis, coughing, dyspnea, infection, pharyngitis, pneumonia, rhinitis, sinusitis, upper respiratory tract

Skin and Appendages Disorders: alopecia, bullous eruption, hypertrichosis, rash, skin ulceration

Urinary System Disorders: dysuria, micturition frequency, increased NPN, urinary tract infection

Vascular (Extracardiac) Disorders: purpura

In addition, the following adverse events have been reported in 1% to < 3% of the rheumatoid arthritis patients in the cyclosporine treatment group in controlled clinical trials.

Autonomic Nervous System: increased sweating, dry mouth

Body as a Whole: asthenia, allergy, hot flushes, overdose, malaise, procedure, tumor, weight increase, weight decrease

Cardiovascular: cardiac failure, abnormal heart sounds, myocardial infarction, peripheral ischemia

Central and Peripheral Nervous System: neuropathy, hypoesthesia, vertigo

Endocrine: goiter

Gastrointestinal: dysphagia, constipation, enanthema, esophagitis, eructation, gastric ulcer, gastroenteritis, gastritis, gingival bleeding, peptic ulcer, glossitis, salivary gland enlargement, tooth disorder, tongue disorder

Infection: bacterial infection, abscess, cellulitis, fungal infection, folliculitis, herpes simplex, herpes zoster, moniliasis, renal abscess, tonsillitis, viral infection

Hematologic: epistaxis, anemia, leukopenia, lymphadenopathy

Liver and Biliary System: bilirubinemia

Metabolic and Nutritional: diabetes mellitus, hyperuricemia, hyperkalemia, hypoglycemia

Musculoskeletal System: bone fracture, arthralgia, bursitis, myalgia, joint dislocation, stiffness, tendon disorder, synovial cyst

Neoplasms: carcinoma, breast fibroadenosis

Psychiatric: confusion, anxiety, decreased libido, impaired concentration, emotional lability, increased libido, paroniria, nervousness, somnolence

Reproductive (Female): uterine hemorrhage, breast pain

Respiratory System: bronchospasm, abnormal chest sounds

Skin and Appendages: angioedema, abnormal pigmentation, dermatitis, eczema, dry skin, nail disorder, skin disorder, pruritus, urticaria

Special Senses: cataract, abnormal vision, conjunctivitis, eye pain, deafness, taste perversion, vestibular disorder, tinnitus

Urinary System: hematuria, abnormal urine, increased BUN, nocturia, micturition urgency, polyuria, urinary incontinence, pyelonephritis

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