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Note: This document contains side effect information about posaconazole. Some of the dosage forms listed on this page may not apply to the brand name Noxafil.
Common side effects of Noxafil include: cytomegalovirus disease, febrile neutropenia, herpes simplex infection, abdominal pain, anemia, arthralgia, back pain, constipation, cough, diarrhea, dizziness, dyspepsia, epistaxis, fatigue, fever, headache, hyperbilirubinemia, hyperglycemia, hypertension, hypokalemia, hypotension, insomnia, lower extremity edema, mucositis, musculoskeletal pain, nausea, neutropenia, petechia, pharyngitis, pruritus, rigors, skin rash, tachycardia, thrombocytopenia, vaginal hemorrhage, vomiting, anorexia, and bacteremia. Other side effects include: upper respiratory tract infection, anxiety, asthenia, edema, hypocalcemia, and prolonged qt interval on ecg. See below for a comprehensive list of adverse effects.
Applies to posaconazole: oral suspension, oral tablet delayed release
Other dosage forms:
Along with its needed effects, posaconazole (the active ingredient contained in Noxafil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking posaconazole:
Incidence not known
Some side effects of posaconazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to posaconazole: intravenous solution, oral delayed release tablet, oral suspension
Thrombophlebitis was very common when multiple doses of the injection were administered via peripheral venous catheter, leading to administration via central venous catheter in later studies. The most common side effects reported with the IV injection were diarrhea, hypokalemia, pyrexia, and nausea.
The most common side effects reported with the delayed-release tablets were diarrhea, pyrexia, and nausea. The most common side effect leading to discontinuation of the delayed-release tablets was nausea (2%).
The most common side effects reported with the oral suspension in the prophylaxis clinical trials were fever, diarrhea, and nausea. The most common side effects leading to discontinuation of the oral suspension in these trials were associated with gastrointestinal disorders, including nausea (2%), vomiting (2%), and increased liver enzymes (2%).
The most common side effects reported with the oral suspension in the oropharyngeal candidiasis and refractory oropharyngeal candidiasis trials were fever, diarrhea, nausea, headache, vomiting, and coughing. The most common side effects leading to discontinuation of the oral suspension were respiratory impairment (1%) and pneumonia (1%) in patients with oropharyngeal candidiasis and AIDS (7%) and respiratory impairment (3%) in patients with refractory oropharyngeal candidiasis. Side effects occurred more often in patients with refractory oropharyngeal candidiasis. Serious side effects were reported in 55% of highly immunocompromised patients with advanced HIV disease. Fever (13%) and neutropenia (10%) were the serious side effects reported most often in these patients. Other serious side effects included altered drug levels (of other products), increased hepatic enzymes, nausea, rash, vomiting, bilirubinemia, and hepatocellular damage.
Very common (10% or more): Diarrhea (up to 42%), nausea (up to 38%), vomiting (up to 29%), abdominal pain (up to 27%), constipation (up to 21%), oral candidiasis (up to 12%), upper abdominal pain (up to 11%)
Common (1% to 10%): Dyspepsia, dry mouth, flatulence
Uncommon (0.1% to 1%): Mucositis, taste perversion, pancreatitis, mouth ulceration, loose stools, abdominal distension, dysphagia, ascites, eructation, gastritis, gastroesophageal reflux disease, esophagitis, tongue edema, tongue discoloration, tooth discoloration, mouth edema
Rare (less than 0.1%): Gastrointestinal hemorrhage, ileus, esophageal candidiasis, increased amylase, increased lipase, abdominal tenderness, cheilitis, hemorrhagic diarrhea, esophageal ulceration, hemorrhagic gastritis, odynophagia, increased pancreatic enzymes, proctalgia, retching, aphthous stomatitis, tenesmus, melena, gingivitis, glossitis, stomatitis
Very common (10% or more): Fever/pyrexia (up to 45%), rigors (up to 20%), fatigue (up to 17%), peripheral edema (16%), chills (up to 16%), leg edema (15%), mucosal inflammation (14%), asthenia (up to 13%), herpes simplex (up to 11%), pain (up to 11%)
Common (1% to 10%): Edema, weakness
Uncommon (0.1% to 1%): Altered drug levels, malaise, flushing, hot flushes, thirst, drug toxicity
Rare (less than 0.1%): Face edema, catheter-related infection, non-herpetic cold sores
Frequency not reported: Bacteremia, cytomegalovirus infection
Very common (10% or more): Hypokalemia (up to 30%), anorexia (up to 19%), hypomagnesemia (up to 18%), decreased weight (up to 14%), decreased appetite (up to 12%), hyperglycemia (up to 11%), dehydration (up to 11%)
Common (1% to 10%): Hypocalcemia, electrolyte imbalance
Uncommon (0.1% to 1%): Hypertriglyceridemia, hyperuricemia, increased LDH
Rare (less than 0.1%): Hypercholesterolemia, hyperlipemia, hyperproteinemia, hypoalbuminemia, metabolic acidosis, vitamin K deficiency, increased weight
Rare occurrences of hemolytic uremic syndrome and thrombotic thrombocytopenic purpura have been reported, generally in patients with concurrent cyclosporine or tacrolimus therapy for the prevention of transplant rejection or graft versus host disease.
Very common (10% or more): Thrombocytopenia (up to 29%), anemia (up to 25%), neutropenia (up to 23%)
Common (1% to 10%): Hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, aggravated neutropenia
Uncommon (0.1% to 1%): Leukopenia, eosinophilia, lymphadenopathy
Rare (less than 0.1%): Pancytopenia, coagulopathy/coagulation disorder, hemorrhage, abnormal blood gases, neutrophilia, increased platelet count, decreased prothrombin, prolonged prothrombin time, purpura
Frequency not reported: Febrile neutropenia
Very common (10% or more): Headache (up to 28%), dizziness (up to 11%)
Common (1% to 10%): Paresthesia, somnolence
Uncommon (0.1% to 1%): Tremor, convulsions, neuropathy, hypoesthesia, earache, vertigo, aphasia
Rare (less than 0.1%): Cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope, hearing impairment, areflexia, ataxia, impaired cognition, dysphonia, dystonia, hemiparesis, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, impaired concentration, memory impairment, meningism, mononeuritis, restless leg syndrome, sciatica, tinnitus
Very common (10% or more): Coughing (up to 25%), dyspnea (up to 20%), epistaxis (up to 17%), pharyngitis (up to 12%)
Common (1% to 10%): Pneumonia, pulmonary embolism
Uncommon (0.1% to 1%): Sinusitis, chest pain, nasal congestion, hiccups, pleuritic pain
Rare (less than 0.1%): Pulmonary hypertension, interstitial pneumonia, pneumonitis, upper respiratory tract infection, atelectasis, dry throat, nasal irritation, postnasal drip, pulmonary infiltration, rales, rhinitis, rhinorrhea
Rare occurrences of pulmonary embolus have been reported, generally in patients with concurrent cyclosporine or tacrolimus therapy for the prevention of transplant rejection or graft versus host disease.
Very common (10% or more): Rash (up to 24%), pruritus (up to 11%), petechiae (up to 11%)
Common (1% to 10%): Increased sweating
Uncommon (0.1% to 1%): Alopecia, dry skin, maculopapular rash, urticaria, furunculosis, acne, pruritic rash
Rare (less than 0.1%): Stevens-Johnson syndrome, vesicular rash, dermatitis, erythema, erythematous rash, follicular rash, macular rash, night sweats, seborrhea, skin nodule, ecchymoses
Very common (10% or more): Hypertension (up to 18%), hypotension (up to 14%), tachycardia (up to 12%)
Common (1% to 10%): Torsades de pointes
Uncommon (0.1% to 1%): Long QT syndrome, abnormal ECG, palpitations, bradycardia, QT/QTc prolongation, atrial fibrillation, atrial flutter, bundle branch block, extrasystoles, ventricular hypertrophy, supraventricular extrasystoles, vasculitis
Rare (less than 0.1%): Deep vein thrombosis, sudden death, ventricular tachycardia, cardiorespiratory arrest, cardiac failure, myocardial infarction, aortic valve sclerosis, cardiomegaly, decreased ejection fraction, mitral valve disease, supraventricular tachycardia, premature atrial contractions, premature ventricular contractions, atrioventricular block, atherosclerosis, ischemia, hematoma
One patient taking posaconazole during a clinical trial developed torsades de pointes. This severely ill patient had a history of palpitations, recent cardiotoxic chemotherapy, hypokalemia, and hypomagnesemia; risk factors that may have contributed to or confounded the patient's condition.
Very common (10% or more): Increased AST (up to 17%), changes in ALT (up to 17%), increased alkaline phosphatase (up to 13%), increased ALT (up to 11%)
Common (1% to 10%): Bilirubinemia, changes in bilirubin, increased total bilirubin, increased hepatic enzymes, abnormal hepatic function, hepatitis, hepatomegaly, jaundice, changes in AST, changes in alkaline phosphatase, increased gamma-glutamyl transpeptidase
Uncommon (0.1% to 1%): Hepatocellular damage
Rare (less than 0.1%): Hepatic failure, cholestatic hepatitis, cholestasis, hepatosplenomegaly, liver tenderness, asterixis, splenomegaly
Postmarketing reports: Severe hepatic injury with fatal outcome
Clinically significant liver function test abnormalities during oropharyngeal candidiasis studies included increased AST, alkaline phosphatase, ALT, and total bilirubin. The majority of abnormal liver function tests in patients and healthy subjects were minor, transient, and did not lead to therapy discontinuation.
Changes in liver function tests from Grade 0, 1, or 2 at baseline to Grade 3 or 4 during prophylaxis studies included changes in ALT, bilirubin, AST, and alkaline phosphatase.
Total bilirubin greater than 1.5 times ULN (up to 22%), AST greater than 3 times ULN (up to 17%), alkaline phosphatase greater than 3 times ULN (up to 14%), and ALT greater than 3 times ULN (up to 11%) were reported.
Very common (10% or more): Insomnia (up to 17%)
Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Altered mental status, confusion
Rare (less than 0.1%): Psychotic disorder, depression, amnesia, abnormal dreaming, emotional lability, decreased libido, paroniria, psychosis, delirium
Frequency not reported: Confusional state
Very common (10% or more): Musculoskeletal pain (up to 16%), arthralgia (up to 11%)
Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Myalgia, flank pain, muscle weakness, pain in extremity
Rare (less than 0.1%): Bone pain, chest wall pain, fasciitis, neck stiffness, cramps in the extremities, muscle cramps
Very common (10% or more): Vaginal hemorrhage (10%)
Uncommon (0.1% to 1%): Menstrual disorder, albuminuria, altered micturition frequency, dysuria, hematuria, nocturia
Rare (less than 0.1%): Breast pain, urinary tract infection, micturition disorder, urinary tract obstruction, leukorrhea
Common (1% to 10%): Acute renal failure
Uncommon (0.1% to 1%): Increased blood creatinine, renal failure, renal insufficiency
Rare (less than 0.1%): Renal tubular acidosis, interstitial nephritis, increased BUN, renal calculus
Common (1% to 10%): Adrenal insufficiency
Rare (less than 0.1%): Decreased blood gonadotropins
Common (1% to 10%): Allergic reaction
Rare (less than 0.1%): Hypersensitivity reactions
Uncommon (0.1% to 1%): Blurred vision, conjunctivitis
Rare (less than 0.1%): Diplopia, scotoma, eye pain, dry eyes, periorbital edema, photophobia
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