Elevations in serum concentrations of alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and alkaline phosphatase, asymptomatic jaundice, and hepatitis. Rarely, hepatitis or shock-like syndrome with liver involvement and abnormal liver function test results.
Local, Sensitivity and Dermatologic:
Hypersensitivity reactions characterized by a flu-like syndrome (i.e., fever, chills, sometimes with headache, dizziness, and bone pain, shortness of breath, and malaise), edema of face and extremities, hypotension, shock, dyspnea, wheezing, rash, pruritus, urticaria, acneiform eruptions, pemphigoid reaction, erythema multiforme including Stevens-Johnson syndrome, Lyells syndrome, toxic epidermal necrolysis, vasculitis, exfoliative dermatitis, flushing, and rarely, anaphylaxis.
Headache, drowsiness, fatigue, dizziness, inability to concentrate, mental confusion, behavioral changes, psychosis, and generalized numbness.
Heartburn, epigastric distress, nausea, vomiting, anorexia, abdominal cramps, flatulence, diarrhea, sore mouth and tongue, pseudomembranous colitis, and pancreatic insufficiency.
Ataxia, muscular weakness, myopathy, and pain in muscles, joints and extremities.
Thrombocytopenia, eosinophilia, leukopenia, purpura, hemolytic anemia, hemolysis, hemoglobinuria, decreased hemoglobin concentrations, disseminated intravascular coagulation, agranulocytosis, and cerebral hemorrhage.
Increased blood urea nitrogen (BUN) and serum uric acid concentrations, hemoglobinuria, light chain proteinuria, hematuria, renal insufficiency, interstitial nephritis, acute tubular necrosis, and acute renal failure.
Precipitation of adrenocortical insufficiency and menstrual disturbances.
Visual disturbances, eye irritation, and exudative conjunctivitis.
Mild liver dysfunction, as evidenced by mild and transient elevations in serum concentrations of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin concentrations. Rarely, progressive liver dysfunction, bilirubinuria, jaundice, and severe and sometimes fatal hepatitis.
Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, vasculitis, and, rarely, hypotension.
Seizures, toxic encephalopathy, stupor, euphoria, memory impairment, separation of ideas and reality, loss of self-control, dizziness, vertigo, and toxic psychosis.
Nausea, vomiting, constipation, and epigastric distress.
Ataxia and muscle twitching.
Agranulocytosis, eosinophilia, thrombocytopenia, methemoglobinemia, and hemolytic, sideroblastic, or aplastic anemia.
Hyperglycemia and metabolic acidosis.
Optic neuritis and atrophy.
Tinnitus, peripheral neuritis usually preceded by paresthesia of the feet and hands, dryness of the mouth, Pyridoxine deficiency, pellagra, hyperreflexia, urinary retention, gynecomastia, SLE-like syndrome, and rheumatic syndrome with arthralgia.
Hepatotoxicity appears to be dose-related, and may appear at any time during therapy. Transient increases in serum concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), jaundice, hepatitis, liver tenderness, and hepatomegaly have been reported.
Hypersensitivity reactions, including rash, urticaria, and pruritus have been reported. Rarely, maculopapular rash, acne and photosensitivity with reddish-brown discoloration of exposed skin.
Nausea, vomiting, anorexia, and aggravation of peptic ulcer.
Rarely, porphyria, thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes, increased serum iron concentration, and adverse effects on blood clotting mechanisms.
Dysuria and interstitial nephritis.
Fever, splenomegaly, malaise, and frequently mild arthralgia and myalgia.
Hyperuricemia commonly occurs and may lead to attacks of gout.
Ethambutol HCl: Hepatic:
Cholestatic jaundice, which appeared to be caused by Ethambutol, has been reported in at least one patient who received the drug both alone and in combination with Streptomycin. Transient impairment of liver function, as indicated by abnormal liver function tests, and jaundice have been observed.
Dermatologic and Hypersensitivity:
Dermatitis, erythema multiforme, skin rashes, and pruritus have been reported. Rarely, anaphylactoid reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Headache, dizziness, mental confusion, disorientation, possible hallucinations.
Gastrointestinal upset, abdominal pain, nausea, vomiting, and anorexia have occurred occasionally.
Thrombocytopenia, leukopenia and eosinophilia.
Optic neuritis with decreases in visual acuity, constriction of visual fields, central and peripheral scotomas, and loss of red-green color discrimination. The extent of ocular toxicity appears to be related to the dose and duration of treatment.
Fever, malaise, joint pain, pulmonary infiltrates, elevated serum uric acid levels, precipitation of acute gout, and rarely, numbness and tingling of the extremities due to peripheral neuritis.