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, oral tablet delayed release

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
  • confusion
  • cough
  • diarrhea
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • 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
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • trembling
  • trouble swallowing
  • unexplained weight loss
  • yellow eyes or skin
Less common
  • Fainting
  • irregular heartbeat, recurrent
Incidence not known
  • Anxiety
  • change in mental status
  • chest pain or discomfort
  • darkening of the skin
  • itching or skin rash
  • mental depression
  • seizures
  • sudden shortness of breath or troubled breathing
  • swelling of the eyes or eyelids
  • swelling of the face, fingers, feet, or lower legs
  • weakness

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
  • belching
  • difficulty having a bowel movement (stool)
  • heartburn
  • muscle stiffness
  • pain in the joints
  • trouble sleeping
Less common
  • Bad, unusual, or unpleasant (after) taste
  • change in taste

For Healthcare Professionals

Applies to posaconazole: oral delayed release tablet, oral suspension


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 were 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.


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%), dyspepsia (10%)
Frequency not reported: Mucositis, dry mouth, taste perversion, flatulence


Very common (10% or more): Fever/pyrexia (up to 45%), rigors (up to 20%), fatigue (up to 17%), peripheral edema (16%), leg edema (15%), mucosal inflammation (14%), asthenia (up to 13%), pain (up to 11%), chills (10%)
Common (1% to 10%): Edema (9%), weakness (8%)
Frequency not reported: Altered drug level


Very common (10% or more): Hypokalemia (up to 30%), anorexia (up to 19%), hypomagnesemia (up to 18%), decreased weight (up to 14%), hyperglycemia (11%), dehydration (up to 11%)
Common (1% to 10%): 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.

Very common (10% or more): Thrombocytopenia (up to 29%), anemia (up to 25%), neutropenia (up to 23%), petechiae (11%)
Common (1% to 10%): Hemolytic uremic syndrome (less than 5%), thrombotic thrombocytopenic purpura (less than 5%), aggravated neutropenia (less than 5%)
Frequency not reported: Febrile neutropenia

Nervous system

Very common (10% or more): Headache (up to 28%), dizziness (11%)
Common (1% to 10%): Paresthesia (less than 5%)
Frequency not reported: Tremor


Very common (10% or more): Coughing (up to 25%), dyspnea (up to 20%), epistaxis (14%)
Common (1% to 10%): 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.


Very common (10% or more): Rash (up to 19%), pruritus (11%)
Common (1% to 10%): Increased sweating (up to 10%)


Very common (10% or more): Hypertension (up to 18%), hypotension (14%), tachycardia (12%)
Common (1% to 10%): Torsades de pointes (less than 5%)
Frequency not reported: QT/QTc prolongation, atrial fibrillation, decreased ejection fraction

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 (greater than 3 times upper limit of normal (ULN): up to 17%), changes in ALT (up to 17%), increased alkaline phosphatase (greater than 3 times ULN: up to 13%), increased ALT (greater than 3 times ULN: up to 11%)
Common (1% to 10%): Bilirubinemia (up to 10%), changes in bilirubin (up to 9%), increased total bilirubin (greater than 1.5 times ULN: up to 5%), increased hepatic enzymes (less than 5%), abnormal hepatic function (less than 5%), hepatitis (less than 5%), hepatomegaly (less than 5%), jaundice (less than 5%), increased ALT (less than 5%), increased AST (less than 5%), changes in AST (up to 4%), changes in alkaline phosphatase (up to 3%)
Frequency not reported: Increased gamma-glutamyl transpeptidase, hepatocellular damage

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.


Very common (10% or more): Insomnia (up to 17%)
Common (1% to 10%): Anxiety (9%)


Very common (10% or more): Musculoskeletal pain (16%), arthralgia (11%), back pain (10%)


Very common (10% or more): Pharyngitis (12%), oral candidiasis (up to 12%), herpes simplex (up to 11%)
Common (1% to 10%): Pneumonia (up to 10%)
Frequency not reported: Bacteremia, cytomegalovirus infection, upper respiratory tract infection


Very common (10% or more): Vaginal hemorrhage (10%)


Common (1% to 10%): Acute renal failure (less than 5%)
Frequency not reported: Increased blood creatinine


Common (1% to 10%): Adrenal insufficiency (less than 5%)


Common (1% to 10%): Allergic reaction (less than 5%)
Frequency not reported: Hypersensitivity reactions


Frequency not reported: Blurred vision

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