Summary

More frequently reported side effects include: pruritus. Continue reading for a comprehensive list of adverse effects.

Applies to caspofungin: intravenous powder for solution.

Serious side effects of Caspofungin

Along with its needed effects, caspofungin 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 or nurse immediately if any of the following side effects occur while taking caspofungin:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blue lips, fingernails, or skin
• blurred vision
• changes in skin color
• chest pain
• confusion
• cough
• cracked lips
• decreased urine
• diarrhea
• difficult or troubled breathing
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fever
• headache
• increased thirst
• irregular heartbeat
• irregular, fast, slow, or shallow breathing
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea
• nervousness
• numbness or tingling in your hands, feet, or lips
• pain or redness at the injection site
• pain, tenderness, or swelling of the foot or leg
• pale skin
• pounding in the ears
• rapid weight gain
• seizures
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• sweating
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Less common

• Bloody urine
• decreased frequency or amount of urine
• increased blood pressure
• lower back or side pain
• weight gain
• yellow eyes or skin

Incidence not known

• Black, tarry stools
• bladder pain
• bleeding gums
• blood in the urine or stools
• bloody nose
• chest pain or discomfort
• clay-colored stools
• cloudy urine
• constipation
• dark urine
• decreased appetite
• depression
• drowsiness
• fever with or without chills
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• general feeling of tiredness or weakness
• incoherent speech
• increased hunger
• increased urination
• indigestion
• itching
• light-colored stools
• metallic taste
• muscle spasms (tetany) or twitching seizures
• muscle weakness
• no blood pressure or pulse
• noisy, rattling breathing
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• rapid weight gain
• rash
• right upper abdominal or stomach pain and fullness
• shakiness in the legs, arms, hands, or feet
• stomach pain, continuous
• stomach pain or tenderness
• stopping of heart
• trembling or shaking of the hands or feet
• troubled breathing at rest
• ulcers, sores, or white spots in the mouth
• unconsciousness
• unexplained weight loss
• unpleasant breath odor
• vomiting of blood
• weakness
• weight loss

Other side effects of Caspofungin

Some side effects of caspofungin 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

• Flushing, redness of the skin
• unusually warm skin

Incidence not known

• Back pain
• belching
• blistering, peeling, or loosening of the skin
• bloated or feeling of fullness
• bumps on the skin
• difficulty in moving
• dry, red, hot, or irritated skin
• fear
• flaking and falling off of the skin
• heartburn
• hives or welts
• indigestion
• joint or muscle pain
• lack or loss of strength
• muscle pain or stiffness
• pressure in the stomach
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• sleepiness or unusual drowsiness
• small red or purple spots on the skin
• stomach discomfort, upset, or pain
• swelling of the abdominal or stomach area
• trouble sleeping

For Healthcare Professionals

Applies to caspofungin: intravenous powder for injection.

Other

Infusion-related adverse reactions were defined as a systemic event (e.g., pyrexia, chills, flushing, hypotension, hypertension, tachycardia, dyspnea, tachypnea, rash, anaphylaxis) that developed during the study therapy infusion and 1 hour after infusion.^[Ref]

Very common (10% or more): Infusion-related adverse reactions (e.g., flushing, fever, chills, hypotension, hypertension, tachycardia, dyspnea, tachypnea, rash, anaphylaxis; up to 35%), pyrexia/fever (up to 27%), chills (up to 23%), decreased blood potassium (up to 23%), increased blood alkaline phosphatase (up to 22%), peripheral edema (up to 11%)

Common (1% to 10%): Decreased blood albumin, decreased blood magnesium, mucosal inflammation, pain, decreased total serum protein, facial edema, influenza-like illness, flushing, decreased serum calcium, warm sensation, decreased serum sodium

Uncommon (0.1% to 1%): Increased serum potassium, decreased serum bicarbonate, increased blood calcium, hot flush, feeling cold, feeling hot, tenderness, chest discomfort, chest pain, feeling of body temperature change, induration, malaise, fatigue, edema , increased blood sodium, decreased blood chloride, increased blood chloride, increased immunosuppressant drug level

Frequency not reported: Asthenia, bacteremia, sepsis, central line infection, decreased blood phosphorus, increased blood phosphorus, septic shock, aspergillosis

Postmarketing reports: Swelling, peripheral edema^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 27%), vomiting (up to 17%), nausea (up to 15%)

Common (1% to 10%): Abdominal pain

Uncommon (0.1% to 1%): Abdominal distension, upper abdominal pain, dry mouth, constipation, dyspepsia, stomach discomfort, ascites, dysphagia, flatulence

Postmarketing reports: Pancreatitis^[Ref]

Cardiovascular

Very common (10% or more): Phlebitis (up to 25%), hypotension (up to 20%), phlebitis/thrombophlebitis (up to 15.7%), infused vein complications (up to 12%)

Common (1% to 10%): Tachycardia, hypertension

Uncommon (0.1% to 1%): Palpitations, arrhythmia, atrial fibrillation, congestive cardiac failure, increased blood pressure

Frequency not reported: Bradycardia, cardiac arrest, myocardial infarction^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 21%), decreased hematocrit (up to 18%), decreased WBC count (up to 12%), anemia (up to 11%)

Common (1% to 10%): Increased eosinophils/eosinophil count, decreased platelet count, increased lymphocytes, increased/prolonged prothrombin time

Uncommon (0.1% to 1%): Thrombocytopenia, coagulopathy, leukopenia, decreased lymphocyte count, increased WBC count, decreased neutrophil count, shortened prothrombin time, prolonged activated partial thromboplastin time, increased INR

Frequency not reported: Febrile neutropenia, neutropenia^[Ref]

A 68-year-old male experienced reversible severe thrombocytopenia coincident with this drug. He was admitted for shortness of breath, coughing, abdominal pain, and intermittent fever, which had persisted for 10 days. Two blood cultures obtained on admission revealed Candida albicans. He was given 70 mg for 1 day, then 50 mg per day. One week after receiving this drug, his platelet count dropped precipitously from 136 x 10(3)/mm3 to 24 x 10(3)/mm3, reaching a nadir at 3 x 10(3)/mm3 in 2 days. The drug was discontinued, and his platelet count returned to a level above 150 x 10(3)/mm3 within 10 days.^[Ref]

Respiratory

Very common (10% or more): Respiratory failure (up to 20%)

Common (1% to 10%): Dyspnea, rales, cough, pneumonia, tachypnea

Uncommon (0.1% to 1%): Nasal congestion, pharyngolaryngeal pain, bronchospasm, paroxysmal nocturnal dyspnea, hypoxia, wheezing, abnormal breath sounds

Frequency not reported: Epistaxis, pulmonary edema, adult respiratory distress syndrome, radiographic infiltrates, pleural effusion^[Ref]

Hepatic

Reported elevations in ALT and AST were accompanied by the use of cyclosporine in some of the patients enrolled in the clinical trials.^[Ref]

Very common (10% or more): Increased ALT (up to 18%), increased AST (up to 16%), increased blood bilirubin/total bilirubin (up to 13%)

Common (1% to 10%): Increased conjugated bilirubin/direct bilirubin, elevated liver values (ALT, AST, blood alkaline phosphatase, conjugated bilirubin, blood bilirubin)

Uncommon (0.1% to 1%): Cholestasis, hepatomegaly, hepatotoxicity, hyperbilirubinemia, jaundice, abnormal hepatic function, liver disorder, increased GGT

Frequency not reported: Hepatic failure, clinically significant hepatic dysfunction, hepatitis

Postmarketing reports: Hepatic necrosis, hepatic dysfunction, increased GGT^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 16%)

Common (1% to 10%): Erythema, hyperhidrosis/sweating/perspiration/diaphoresis, pruritus

Uncommon (0.1% to 1%): Erythema multiforme, macular rash, maculopapular rash, pruritic rash, urticaria, allergic dermatitis, generalized pruritus, erythematous rash, generalized rash, morbilliform rash, skin lesion

Frequency not reported: Petechiae, decubitus ulcer

Postmarketing reports: Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, skin exfoliation^[Ref]

Nervous system

Very common (10% or more): Headache (up to 15%)

Common (1% to 10%): Paresthesia, tremor, dizziness

Uncommon (0.1% to 1%): Dysgeusia, somnolence, hypoesthesia

Frequency not reported: Convulsion^[Ref]

Renal

Very common (10% or more): Increased blood creatinine (up to 11%)

Common (1% to 10%): Increased blood urea nitrogen, nephrotoxicity

Uncommon (0.1% to 1%): Renal insufficiency, renal failure, acute renal failure

Frequency not reported: Clinical renal events

Postmarketing reports: Clinically significant renal dysfunction^[Ref]

Nephrotoxicity was defined as doubling of serum creatinine compared to baseline or an increase of at least 1 mg/dL in serum creatinine if baseline level was above the upper limit of normal.^[Ref]

Genitourinary

Very common (10% or more): Urine positive for RBCs (up to 10%)

Common (1% to 10%): Increased urine WBCs, increased urine protein, increased urine RBCs

Uncommon (0.1% to 1%): Increased urine pH, protein present in urine, blood present in urine, urinary casts, urine positive for WBCs

Frequency not reported: Urinary tract infection, hematuria^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions, anaphylaxis, possible histamine-mediated symptoms (including rash, facial swelling, angioedema, pruritus, sensation of warmth, bronchospasm)^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, increased blood glucose, hypomagnesemia, anorexia

Uncommon (0.1% to 1%): Increased serum uric acid, fluid overload, electrolyte imbalance, hyperglycemia, hypocalcemia, metabolic acidosis, decreased blood uric acid, decreased carbon dioxide

Frequency not reported: Decreased appetite, hypoalbuminemia

Postmarketing reports: Hypercalcemia^[Ref]

Local

Common (1% to 10%): Injection site phlebitis, injection site swelling, injection site erythema, infusion site pruritus

Uncommon (0.1% to 1%): Catheter site pain, infusion site erythema, infusion site induration, infusion site pain, infusion site swelling, infusion site extravasation, infusion site irritation, infusion site phlebitis, infusion site rash, infusion site urticaria, injection site edema, injection site pain^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Anxiety, disorientation

Frequency not reported: Confusional state, depression^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, musculoskeletal pain

Uncommon (0.1% to 1%): Back pain, pain in extremity, bone pain, muscular weakness^[Ref]

Ocular

Uncommon (0.1% to 1%): Ocular icterus, blurred vision, eyelid edema, increased lacrimation^[Ref]