Posaconazole Side Effects

Brand Names: Noxafil

Please note - some side effects for Posaconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Posaconazole - for the Consumer

Posaconazole Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Posaconazole Suspension:

Anxiety; constipation; coughing; diarrhea; dizziness; headache; muscle, joint, or back pain; nausea; sore throat; stomach pain or upset; tiredness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mouth inflammation; pale stools; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the ankles, feet, or hands; tremor; unusual bruising or bleeding; vaginal bleeding; yellowing of the skin or eyes.

Side Effects by Body System

Immunologic

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

Hematologic

Hematologic side effects have included thrombocytopenia (29%), anemia (25%), neutropenia (23%), febrile neutropenia (20%), and petechiae (11%). Rare side effects have included hemolytic uremic syndrome and thrombotic thrombocytopenic purpura.

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.

Cardiovascular

Cardiovascular side effects have included hypertension (18%), hypotension (14%), and tachycardia (12%). Treatment-related side effects have included hypertension (1%) and QT/QTc prolongation (4%). Rare side effects have included pulmonary embolus and torsades de pointes. 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 confused the patient's condition.

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.

Hepatic

Hepatic side effects have included bilirubinemia (10%). Treatment-related side effects have included bilirubinemia (up to 3%), increased hepatic enzyme (up to 3%), increased serum glutamic pyruvic transaminase (SGPT) (up to 3%), increased serum glutamic oxaloacetic transaminase (SGOT) (up to 3%), and increased gamma-glutamyl transpeptidase (GGT) (up to 3%). The most common treatment-related serious side effects reported in 1% of patients have included bilirubinemia, increased hepatic enzymes, and hepatocellular damage.

Metabolic

Metabolic side effects have included hypokalemia (30%), hypomagnesemia (18%), hyperglycemia (11%), and hypocalcemia (9%). Treatment-related side effects have included hypokalemia (3%) and increased phosphatase alkaline (2%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (42%), nausea (38%), vomiting (29%), abdominal pain (27%), constipation (21%), mucositis (17%), anorexia (15%), dry mouth (10% or greater), and dyspepsia (10%). Treatment-related side effects have included nausea (7%), diarrhea (up to 7%), vomiting (up to 5%), abdominal pain (up to 3%), mucositis (2%), dyspepsia (up to 2%), anorexia (1%), taste perversion (1%), and constipation (up to 1%). The most common treatment-related serious side effects reported have included nausea (1%) and vomiting (1%).

General

General side effects have included fever (45%), headache (28%), rigors (20%), leg edema (15%), edema (9%), and weakness (8%). Treatment-related side effects have included altered drug level (2%), headache (up to 2%), and weakness (1%).

Nervous system

Nervous system side effects have included insomnia (17%), fatigue (17%), dizziness (11%), and anxiety (9%). Treatment-related side effects have included dizziness (1%), fatigue (1%), and tremor (1%).

Genitourinary

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

Respiratory

Respiratory side effects have included coughing (24%), dyspnea (20%), and epistaxis (14%).

Dermatologic

Dermatologic side effects have included rash (19%) and pruritus (11%). Treatment-related side effects have included rash (3%).

Musculoskeletal

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

Renal

Renal side effects have included increased blood creatinine (2%).

Ocular

Ocular side effects have included treatment-related blurred vision (1%).

Endocrine

Endocrine side effects have included treatment-related adrenal insufficiency (rare and uncommon).

Hypersensitivity

Hypersensitivity side effects have included treatment-related allergic and/or hypersensitivity reactions (rare and uncommon).

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