AMPHOTERICIN B LIPID COMPLEX INJECTION 10,25,50 & 100 MG

CARDIOVASCULAR

Phlebitis (25%); hypertension, tachycardia (23%); hypotension (22%); chest pain (12%); cardiac arrest (6%); vasodilatation (5%); atrial fibrillation, bradycardia, cardiac arrest, cardiomegaly, hemorrhage, postural hypotension, valvular heart disease, vascular disorder (2% to 10%); cardiovascular disorder (at least 5%); CHF, shock, supraventricular tachycardia, syncope, ventricular extrasystoles (1% to less than 5%); MI, shock, tachypnea.

CNS

Insomnia (22%); headache (21%); anxiety (14%); asthenia, confusion (13%); dizziness (10%); abnormal thinking, agitation, coma, convulsions, depression, dysesthesia, hallucinations, malaise, nervousness, paresthesia, somnolence, tremor (2% to 10%); hypertonia, neuropathy, psychosis, speech disorder, stupor (1% to less than 5%); cerebral vascular accident, diplopia, encephalopathy, extrapyramidal syndrome, peripheral neuropathy, transient vertigo.

DERMATOLOGIC

Rash (25%); pruritus, sweating (11%); alopecia, dry skin, herpes simplex, maculopapular rash, purpura, skin discoloration, skin disorder, skin ulcer, urticaria, vesiculobullous rash (2% to 10%); acne, petechial rash, skin nodule (1% to less than 5%); erythema, erythema multiforme, exfoliative dermatitis, flushing.

EENT

Conjunctivitis, dry eyes, eye hemorrhage, pharyngitis (2% to 10%); amblyopia, deafness, ear disorder, tinnitus (1% to less than 5%); visual impairment.

GI

Vomiting (44%); nausea (40%); diarrhea (30%); abdominal pain (22%); constipation (21%); anorexia (14%); GI hemorrhage, nausea and vomiting (11%); abdomen enlarged, dry mouth/nose, dyspepsia, dysphagia, eructation, fecal incontinence, flatulence, hemorrhoids, gum/oral hemorrhage, hematemesis, ileus, mucositis, rectal disorder, stomatitis, ulcerative stomatitis (2% to 10%); bloody diarrhea, GI disorder, gingivitis, glossitis, increased GGT, melena, mouth ulceration, oral moniliasis, rectal disorder (1% to less than 5%); cramping, epigastric pain.

GENITOURINARY

Nephrotoxicity (63%); hematuria (14%); kidney failure (5%); abnormal renal function, acute kidney failure, acute renal failure, dysuria, toxic nephropathy, urinary incontinence, vaginal hemorrhage (2% to 10%); albuminuria, glucosuria, oliguria, urinary retention, urinary tract disorder (1% to less than 5%); anuria, azotemia, decreased renal function, hemorrhagic cystitis, hyposthenuria, impotence, nephrocalcinosis, renal tubular acidosis.

HEMATOLOGIC-LYMPHATIC

Anemia (48%); leukopenia (17%); thrombocytopenia (13%); coagulation disorder, decreased or increased prothrombin, ecchymosis, fluid overload, petechiae (2% to 10%); decreased thromboplastin, hypochromic anemia, increased fibrinogen, leukocytosis (1% to less than 5%); blood dyscrasias including coagulation defects, eosinophilia, normochromic or normocytic anemia; agranulocytosis (postmarketing).

HEPATIC

Bilirubinemia (19%); increased ALT (15%); abnormal LFTs, increased AST (13%); hepatocellular damage, hepatomegaly, veno-occlusive liver disease (2% to 10%); jaundice (at least 5%); liver failure (1% to less than 5%); cholangitis, cholecystitis, hepatitis.

HYPERSENSITIVITY

Allergic reaction (2% to 10%); anaphylactic and anaphylactoid reactions, bronchospasm, hypersensitivity pneumonitis, wheezing.

LOCAL

Injection-site inflammation (2% to 10%); injection-site pain, injection-site reaction (1% to less than 5%); thrombophlebitis.

METABOLIC-NUTRITIONAL

Hypokalemia (51%); hypomagnesemia, increased creatinine (49%); increased BUN (31%); hyperglycemia (28%); increased alkaline phosphatase (22%); hypocalcemia (21%); peripheral edema (17%); edema, hypervolemia (15%); hyponatremia (12%); hypernatremia (11%); acidosis, hyperchloremia, hyperkalemia, hypermagnesemia, hyperphosphatemia, hypophosphatemia, hypoproteinemia, increased amylase, increased LDH, increased nonprotein nitrogen, respiratory alkalosis (2% to 10%); weight gain (at least 5%); dehydration, hyperlipidemia, hypoglycemia, weight loss (1% to less than 5%); hyperamylasemia, hyperuricemia.

MUSCULOSKELETAL

Back pain (12%); arthralgia, bone pain, dystonia, myalgia, neck pain, rigors (2% to 10%); myasthenia including bone, joint, and muscle pain.

RESPIRATORY

Dyspnea (29%); increased cough (22%); hypoxia (21%); epistaxis (20%); lung disorder (18%); pleural effusion (13%); rhinitis (11%); respiratory failure (8%); apnea (at least 5%); hyperventilation (5%); asthma, atelectasis, hemoptysis, hiccup, lung edema, pneumonia, respiratory insufficiency, sinusitis (2% to 10%); respiratory disorder (1% to less than 5%); bronchospasm, cyanosis/hypoventilation, pulmonary edema (postmarketing).

MISCELLANEOUS

Chills/rigors (90%); chills (77%); fever (58%); blood product transfusion reaction (19%); pain, sepsis (14%); infection (13%); multiple organ failure (11%); procedural complications (10%); cell-mediated immunological reaction, cellulitis, face edema, graft-versus-host disease, influenza-like symptoms (2% to 10%); chills/fever (7%); mucous membrane disorder (at least 5%); death, hypothermia, immune system disorder (1% to less than 5%); angioedema (postmarketing).