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
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:More common
- Abdominal or stomach pain
- black, tarry stools
- bloody nose
- blurred vision
- body aches or pain
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever or chills
- fruit-like breath odor
- heavy non-menstrual vaginal bleeding
- increased thirst or urination
- irregular heartbeats
- loss of voice
- muscle pain, spasms or twitching
- nausea or vomiting
- numbness or tingling in the hands, feet, lips, mouth, or fingertips
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pounding in the ears
- slow or fast heartbeat
- small red or purple spots on the skin
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- tender, swollen glands in the neck
- tightness in the chest
- trouble with swallowing
- unexplained weight loss
- yellow eyes or skin
- irregular heartbeat, recurrent
- change in mental status
- chest pain or discomfort
- darkening of the skin
- itching or skin rash
- mental depression
- sudden shortness of breath or troubled breathing
- swelling of the eyes or eyelids
- swelling of the face, fingers, feet, or lower legs
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:More common
- Acid or sour stomach
- back pain
- difficulty having a bowel movement (stool)
- muscle stiffness
- pain in the joints
- trouble sleeping
- Bad, unusual, or unpleasant (after) taste
- change in taste
For Healthcare Professionals
Applies to posaconazole: oral suspension
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 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 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 side effects have included hypokalemia (up to 30%), hypomagnesemia (18%), decreased weight (up to 14%), hyperglycemia (11%), dehydration (up to 11%), and hypocalcemia (9%).
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 side effects have included headache (up to 28%), insomnia (up to 17%), dizziness (11%), paresthesia (less than 5%), and tremor.
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 side effects have included rash (up to 19%), pruritus (11%), and increased sweating (up to 10%).
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 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 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 side effects have included musculoskeletal pain (16%), arthralgia (11%), and back pain (10%).
Genitourinary side effects have included vaginal hemorrhage (10%).
Psychiatric side effects have included anxiety (9%).
Renal side effects have included acute renal failure (less than 5%) and increased blood creatinine.
Endocrine side effects have included adrenal insufficiency (less than 5%).
Hypersensitivity side effects have included allergic reaction (less than 5%) and/or hypersensitivity reactions.
Ocular side effects have included blurred vision.
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