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Posaconazole Side Effects

Medically reviewed by Last updated on Oct 31, 2020.

In Summary

Commonly reported side effects of posaconazole 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.

For the Consumer

Applies to posaconazole: oral suspension, oral tablet delayed release

Other dosage forms:

Side effects requiring immediate medical attention

Along with its needed effects, posaconazole 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

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

Side effects not requiring immediate medical attention

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: 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.[Ref]


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[Ref]


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[Ref]


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[Ref]


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.[Ref]

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[Ref]

Nervous system

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[Ref]


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.[Ref]

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[Ref]


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[Ref]


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.[Ref]

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[Ref]


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[Ref]

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.[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


Common (1% to 10%): Adrenal insufficiency

Rare (less than 0.1%): Decreased blood gonadotropins[Ref]


Common (1% to 10%): Allergic reaction

Rare (less than 0.1%): Hypersensitivity reactions[Ref]


Uncommon (0.1% to 1%): Blurred vision, conjunctivitis

Rare (less than 0.1%): Diplopia, scotoma, eye pain, dry eyes, periorbital edema, photophobia[Ref]


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2. Rachwalski EJ, Wieczorkiewicz JT, Scheetz MH "Posaconazole: an oral triazole with an extended spectrum of activity." Ann Pharmacother 42 (2008): 1429-38

3. Morris MI "Posaconazole: a new oral antifungal agent with an expanded spectrum of activity." Am J Health Syst Pharm 66 (2009): 225-36

4. "Product Information. Noxafil (posaconazole)." Schering-Plough Corporation, Kenilworth, NJ.

5. Thompson GR 3rd, Cadena J, Patterson TF "Overview of antifungal agents." Clin Chest Med 30 (2009): 203-15, v

6. Courtney R, Pai S, Laughlin M, Lim J, Batra V "Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults." Antimicrob Agents Chemother 47 (2003): 2788-95

7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

8. Krishna G, Ma L, Martinho M, Preston RA, O'Mara E "A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers." J Antimicrob Chemother 67 (2012): 2725-30

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.