Posaconazole Side Effects

It is possible that some side effects of posaconazole may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to posaconazole: oral suspension, oral tablet delayed release

Other dosage forms:

As well as its needed effects, posaconazole may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking posaconazole, check with your doctor immediately:

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 posaconazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

General

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.

Gastrointestinal

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, esophagitis, tongue edema, tongue discoloration, tooth discoloration
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

Other

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

Metabolic

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

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.

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

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
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

Respiratory

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
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

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

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

Cardiovascular

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, QT/QTc prolongation, atrial fibrillation, atrial flutter, bundle branch block, extrasystoles, ventricular hypertrophy
Rare (less than 0.1%): Deep vein thrombosis, sudden death, ventricular tachycardia, cardiorespiratory arrest, cardiac failure, myocardial infarction, bradycardia, aortic valve sclerosis, cardiomegaly, decreased ejection fraction, mitral valve disease, supraventricular tachycardia, premature atrial contractions, premature ventricular contractions, atrioventricular block, atherosclerosis, ischemia, hematoma

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.

Hepatic

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

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.

Psychiatric

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

Musculoskeletal

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
Rare (less than 0.1%): Bone pain, chest wall pain, fasciitis, neck stiffness, cramps in the extremities, muscle cramps

Genitourinary

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

Renal

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

Endocrine

Common (1% to 10%): Adrenal insufficiency
Rare (less than 0.1%): Decreased blood gonadotropins

Hypersensitivity

Common (1% to 10%): Allergic reaction
Rare (less than 0.1%): Hypersensitivity reactions

Ocular

Uncommon (0.1% to 1%): Blurred vision, conjunctivitis
Rare (less than 0.1%): Diplopia, scotoma, eye pain, dry eyes, periorbital edema, photophobia

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