Estimated 0.01%-0.1%: vesicular rash, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, acute febrile neutrophilic dermatosis (Sweet’s syndrome), nail discoloration, angioneurotic edema, erythema multiforme, leucocytoclastic vasculitis

Digestive:

Estimated 1%-10%: abdominal distention, gastroesophageal reflux, dry mouth, gastritis

Estimated 0.1%-1%: gastric ulcer, stomatitis, mouth ulceration, eructation, melena, esophagitis, ascites, hematemesis, chelitis, dysphagia, pancreatitis,

Estimated 0.01%-0.1%: colitis, ileus, inflammatory bowel disease,

General Disorders and Administration Site Conditions:

Estimated 1%-10%: weakness, anasarca, chills

Estimated 0.1%-1%: malaise

Hematologic:

Estimated 1%-10%: pancytopenia, febrile neutropenia

Estimated 0.1%-1%: thrombocythemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy

Estimated 0.01%-0.1%:hemolytic anemia, aplastic anemia

Hepatobiliary:

Estimated 0.1%-1%:hepatitis, jaundice

Estimated 0.01%-0.1%: hepatic failure and hepatic necrosis1

Hypersensitivity:

Estimated 0.01%-0.1%: angioedema

Infections:

Estimated 0.1%-1%: sepsis, herpes simplex, herpes zoster, cellulitis, urinary tract infection, gastroenteritis

Estimated 0.01%-0.1%: fungal infection

Metabolic and Nutritional:

Estimated 1%-10%: weight decreased

Estimated 0.1%-1%: hypophosphatemia, dehydration, gout, increased appetite, decreased appetite, hyperuricemia, hypercalcemia, hyperglycemia, hyponatremia

Estimated 0.01%-0.1%: hyperkalemia, hypomagnesemia

Musculoskeletal:

Estimated 1%-10%: joint swelling

Estimated 0.1%-1%: joint and muscle stiffness

Estimated 0.01%-0.1%: muscular weakness, arthritis

Nervous System/Psychiatric:

Estimated 1%-10%: paresthesia, hypesthesia

Estimated 0.1%-1%: syncope, peripheral neuropathy, somnolence, migraine, memory impairment, libido decreased, sciatica, restless leg syndrome, tremor

Estimated 0.01%-0.1%: increased intracranial pressure1, confusional state, convulsions, optic neuritis

Renal:

Estimated 0.1%-1%: renal failure acute, urinary frequency increased, hematuria, renal pain

Reproductive:

Estimated 0.1%-1%: breast enlargement, menorrhagia, sexual dysfunction, gynecomastia, erectile dysfunction, menstruation irregular, nipple pain, scrotal edema

Respiratory:

Estimated 1%-10%: epistaxis

Estimated 0.1%-1%: pleural effusion

Estimated 0.01%-0.1%: interstitial pneumonitis, pulmonary fibrosis, pleuritic pain, pulmonary hypertension, pulmonary hemorrhage

Special Senses:

Estimated 1%-10%: conjunctivitis, vision blurred, eyelid edema, conjunctival hemorrhage, dry eye

Estimated 0.1%-1%: vertigo, tinnitus, eye irritation, eye pain, orbital edema, scleral hemorrhage, retinal hemorrhage, blepharitis, macular edema, hearing loss

Estimated 0.01%-0.1%: papilledema1, glaucoma, cataract

1Including some fatalities

6.