Cipol-N Adverse Reactions

Frequency >10%: Cardiovascular: Hypertension (8% to 53%), edema (5% to 14%).
Central nervous system: Headache (2% to 25%), paresthesia (1% to 11%).
Dermatologic: Hypertrichosis (5% to 19%).
Endocrine & metabolic: Hirsutism (21% to 45%), increased serum triglycerides (15%), female genital tract disease (9% to 11%).
Gastrointestinal: Nausea (2% to 23%), diarrhea (3% to 13%), gingival hyperplasia (2% to 16%), abdominal distress (<1% to 15%), dyspepsia (2% to 12%).
Genitourinary: Urinary tract infection (kidney transplant: 21%).
Infection: Increased susceptibility to infection (3% to 25%), viral infection (kidney transplant: 16%).
Neuromuscular & skeletal: Tremor (7% to 55%), leg cramps (2% to 12%).
Renal: Increased serum creatinine (16% to ≥50%), renal insufficiency (10% to 38%).
Respiratory: Upper respiratory infection (1% to 14%).
Kidney, liver, and heart transplant only: Cardiovascular: Chest pain (≤4%), flushing (<1% to 4%), glomerular capillary thrombosis, myocardial infarction.
Central nervous system: Convulsion (1% to 5%), anxiety, confusion, lethargy, tingling sensation.
Dermatologic: Skin infection (7%), acne vulgaris (1% to 6%), nail disease (brittle fingernails), hair breakage, night sweats, pruritus.
Endocrine & metabolic: Gynecomastia (<1% to 4%), hyperglycemia, hypomagnesemia, weight loss.
Gastrointestinal: Vomiting (2% to 10%), anorexia, aphthous stomatitis, constipation, dysphagia, gastritis, hiccups, pancreatitis.
Genitourinary: Hematuria.
Hematologic & oncologic: Leukopenia (<1% to 6%), lymphoma (<1% to 6%), anemia, thrombocytopenia, upper gastrointestinal hemorrhage.
Hepatic: Hepatotoxicity (<1% to 7%).
Infection: Localized fungal infection (8%), cytomegalovirus disease (5%), septicemia (5%), abscess (4%), fungal infection (systemic: 2%).
Neuromuscular & skeletal: Arthralgia, myalgia, weakness.
Ophthalmic: Conjunctivitis, visual disturbance.
Otic: Hearing loss, tinnitus.
Respiratory: Sinusitis (<1% to 7%), pneumonia (6%).
Miscellaneous: Fever.
Rheumatoid arthritis only: Cardiovascular: Chest pain (4%), cardiac arrhythmia (2%), abnormal heart sounds, cardiac failure, myocardial infarction, peripheral ischemia.
Central nervous system: Dizziness (8%), pain (6%), insomnia (4%), depression (3%), migraine (2% to 3%), anxiety, drowsiness, emotional lability, hypoesthesia, lack of concentration, malaise, neuropathy, nervousness, paranoia, vertigo.
Dermatologic: Cellulitis, dermatological reaction, dermatitis, diaphoresis, dyschromia, eczema, enanthema, folliculitis, nail disease, pruritus, urticaria, xeroderma.
Endocrine & metabolic: Menstrual disease (3%), decreased libido, diabetes mellitus, goiter, hot flash, hyperkalemia, hyperuricemia, hypoglycemia, increased libido, weight gain, weight loss.
Gastrointestinal: Vomiting (9%), flatulence (5%), gingivitis (4%), constipation, dysgeusia, dysphagia, enlargement of salivary glands, eructation, esophagitis, gastric ulcer, gastritis, gastroenteritis, gingival hemorrhage, glossitis, peptic ulcer, tongue disease, xerostomia.
Genitourinary: Leukorrhea (1%), breast fibroadenosis, hematuria, mastalgia, nocturia, urine abnormality, urinary incontinence, urinary urgency, uterine hemorrhage.
Hematologic & oncologic: Purpura (3% to 4%), anemia, carcinoma, leucopenia, lymphadenopathy.
Hepatic: Hyperbilirubinemia.
Infection: Abscess (including renal), bacterial infection, candidiasis, fungal infection, herpes simplex infection, herpes zoster, viral infection.
Neuromuscular & skeletal: Arthralgia, bone fracture, dislocation, myalgia, stiffness, synovial cyst, tendon disease, weakness.
Ophthalmic: Cataract, conjunctivitis, eye pain, visual disturbance.
Otic: Tinnitus, deafness, vestibular disturbance.
Renal: Abscess (renal), increased blood urea nitrogen, polyuria, pyelonephritis.
Respiratory: Cough (5%), dyspnea (5%), sinusitis (4%), abnormal breath sounds, bronchospasm, epitaxis, tonsilitis.
Psoriasis only: Cardiovascular: Chest pain, flushing.
Central nervous system: Psychiatric disturbance (4% to 5%), pain (3% to 4%), dizziness, insomnia, nervousness, vertigo.
Dermatologic: Acne vulgaris, folliculitis, hyperkeratosis, pruritus, skin rash, xeroderma.
Endocrine & metabolic: Hot flash.
Gastrointestinal: Abdominal distention, constipation, gingival hemorrhage, increased appetite.
Genitourinary: Urinary frequency.
Hematologic & oncologic: Abnormal erythrocytes, altered platelet function, blood coagulation disorder, carcinoma, hemorrhagic diathesis.
Hepatic: Hyperbillirubinemia.
Neuromuscular & skeletal: Arthralgia (1% to 6%).
Ophthalmic: Visual disturbance.
Respiratory: Flu-like symptoms (8% to 10%), bronchospasm (5%), cough (5%), dyspnea (5%), rhinitis (5%), respiratory tract infection.
Miscellaneous: Fever.