atric
anxiety, confusion, decreased libido, emotional lability, impaired concentration, increased libido, nervousness, paroniria, somnolence
Reproductive (Female)
breast pain, uterine hemorrhage
Respiratory System
abnormal chest sounds, bronchospasm
Skin and Appendages
abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorder, pruritus, skin disorder, urticaria
Special Senses
abnormal vision, cataract, conjunctivitis, deafness, eye pain, taste perversion, tinnitus, vestibular disorder
Urinary System
abnormal urine, hematuria, increased BUN, micturition urgency, nocturia, polyuria, pyelonephritis, urinary incontinence
* NOS = Not Otherwise Specified.
Psoriasis
The principal adverse reactions associated with the use of cyclosporine in patients with psoriasis are renal dysfunction, headache, hypertension, hypertriglyceridemia, hirsutism/hypertrichosis, paresthesia or hyperesthesia, influenza-like symptoms, nausea/vomiting, diarrhea, abdominal discomfort, lethargy, and musculoskeletal or joint pain.
In psoriasis patients treated in U.S. controlled clinical studies within the recommended dose range, cyclosporine therapy was discontinued in 1.0% of the patients because of hypertension and in 5.4% of the patients because of increased creatinine. In the majority of cases, these changes were reversible after dose reduction or discontinuation of cyclosporine.
There has been one reported death associated with the use of cyclosporine in psoriasis.
A 27 year old male developed renal deterioration and was continued on cyclosporine. He had progressive renal failure leading to death.
Frequency and severity of serum creatinine increases with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced and may result in irreversible renal damage without dose reduction or discontinuation.
Adverse Events Occurring in 3% or More of Psoriasis Patients in Controlled Clinical Trials
Body System*
Preferred Term |
Cyclosporine
(MODIFIED)
(N = 182) |
Cyclosporine
(N = 185) |
|
* Total percentage of events within the system.
** Newly occurring hypertension = SBP ≥ 160 mm Hg and/or DBP ≥ 90 mm Hg.
|
|
Infection or Potential Infection |
24.7% |
24.3% |
|
Influenza-like Symptoms |
9.9% |
8.1% |
|
Upper Respiratory Tract Infections |
7.7% |
11.3% |
|
Cardiovascular System |
28.0% |
25.4% |
|
Hypertension** |
27.5% |
25.4% |
|
Urinary System |
24.2% |
16.2% |
|
Increased Creatinine |
19.8% |
15.7% |
|
Central and Peripheral Nervous System |
26.4% |
20.5% |
|
Headache |
15.9% |
14.0% |
|
Paresthesia |
7.1% |
4.8% |
|
Musculoskel |
