Noxafil Side Effects

Generic name: posaconazole

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.

Some side effects of Noxafil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to posaconazole: oral suspension

Get emergency medical help if you have any of these signs of an allergic reaction while taking posaconazole (the active ingredient contained in Noxafil) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• slow heartbeats;

• signs of an infection such as fever, chills, sore throat, flu symptoms, vomiting, mouth sores;

• pale skin, easy bruising or bleeding, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

• feeling like you might pass out;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, seizure).

Less serious side effects of posaconazole may include:

• mild headache, dizziness;

• tired feeling

• swelling of your ankles or feet;

• diarrhea, constipation, stomach pain;

• joint or muscle pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to posaconazole: oral suspension

General

The most common side effects reported in the prophylaxis clinical trials were fever, diarrhea, and nausea. The most common side effects leading to discontinuation of posaconazole (the active ingredient contained in Noxafil) during prophylaxis clinical trials were associated with gastrointestinal disorders (including nausea, vomiting, and increased liver enzymes).

In the oropharyngeal candidiasis and refractory oropharyngeal candidiasis trials, fever, diarrhea, nausea, headache, and vomiting were the most frequent side effects. Respiratory insufficiency and pneumonia were the side effects that led to discontinuation most often in patients with oropharyngeal candidiasis. AIDS and respiratory insufficiency were the side effects that led to treatment discontinuation most frequently in patients with refractory oropharyngeal candidiasis. Side effects were more frequent in patients with refractory oropharyngeal candidiasis. Serious side effects were reported in 55% in highly immunocompromised patients with advanced HIV disease. Fever and neutropenia were the serious side effects reported most often in these patients.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 42%), nausea (up to 38%), vomiting (up to 29%), abdominal pain (up to 27%), constipation (21%), anorexia (up to 19%), mucositis (17%), dyspepsia (10%), dry mouth, taste perversion, and flatulence.

Other

Other side effects have included fever (up to 45%), rigors (up to 20%), fatigue (up to 17%), leg edema (15%), asthenia (up to 13%), pain (up to 11%), edema (9%), and weakness (8%). Altered drug level has been reported.

Metabolic

Metabolic side effects have included hypokalemia (up to 30%), hypomagnesemia (18%), decreased weight (up to 14%), hyperglycemia (11%), dehydration (up to 11%), and hypocalcemia (9%).

Hematologic

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.

Hematologic side effects have included thrombocytopenia (up to 29%), anemia (up to 25%), neutropenia (up to 23%), febrile neutropenia (20%), and petechiae (11%). Hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, and aggravated neutropenia have been reported in less than 5% of patients.

Nervous system

Nervous system side effects have included headache (up to 28%), insomnia (up to 17%), dizziness (11%), paresthesia (less than 5%), and tremor.

Respiratory

Respiratory side effects have included coughing (up to 25%), dyspnea (up to 20%), epistaxis (14%), and pulmonary embolism (less than 5%).

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.

Dermatologic

Dermatologic side effects have included rash (up to 19%), pruritus (11%), and increased sweating (up to 10%).

Cardiovascular

Cardiovascular side effects have included hypertension (18%), hypotension (14%), tachycardia (12%), torsades de pointes (less than 5%), and QT/QTc prolongation. Atrial fibrillation and decreased ejection fraction have also been reported.

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.

Immunologic

Immunologic side effects have included bacteremia (18%), herpes simplex (up to 15%), cytomegalovirus infection (14%), pharyngitis (12%), oral candidiasis (up to 12%), pneumonia (up to 10%), and upper respiratory tract infection (7%).

Hepatic

Hepatic side effects have included bilirubinemia (up to 10%). Increased hepatic enzymes, abnormal hepatic function, hepatitis, hepatomegaly, jaundice, increased serum glutamic pyruvic transaminase (SGPT), and increased serum glutamic oxaloacetic transaminase (SGOT) have been reported in less than 5% of patients. Increased gamma-glutamyl transpeptidase (GGT) and hepatocellular damage have been reported. 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 (up to 17%), bilirubin (up to 9%), AST (up to 4%), and alkaline phosphatase (up to 3%). Clinically significant liver function test abnormalities during oropharyngeal candidiasis studies included abnormal AST (greater than 3 times ULN; up to 17%), alkaline phosphatase (greater than 3 times ULN; up to 13%), ALT (greater than 3 times ULN; up to 11%), and total bilirubin (greater than 1.5 times ULN; up to 5%).

The majority of abnormal liver function tests in patients and healthy subjects were minor, transient, and did not lead to therapy discontinuation.

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal pain (16%), arthralgia (11%), and back pain (10%).

Genitourinary

Genitourinary side effects have included vaginal hemorrhage (10%).

Psychiatric

Psychiatric side effects have included anxiety (9%).

Renal

Renal side effects have included acute renal failure (less than 5%) and increased blood creatinine.

Endocrine

Endocrine side effects have included adrenal insufficiency (less than 5%).

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 5%) and/or hypersensitivity reactions.

Ocular

Ocular side effects have included blurred vision.

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