Note: This document contains side effect information about micafungin. Some dosage forms listed on this page may not apply to the brand name Mycamine.
Summary
Common side effects of Mycamine include: febrile neutropenia, abdominal pain, diarrhea, fever, headache, increased serum alanine aminotransferase, nausea, neutropenia, phlebitis, pruritus, skin rash, thrombocytopenia, and vomiting. Other side effects include: abnormal hepatic function tests. Continue reading for a comprehensive list of adverse effects.
Applies to micafungin: intravenous powder for solution.
Serious side effects of Mycamine
Along with its needed effects, micafungin (the active ingredient contained in Mycamine) 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 micafungin:
More common
- Black, tarry, stools
- cough
- decreased frequency or amount of urine
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- increased thirst
- loss of appetite
- lower back or side pain
- nausea or vomiting
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- swelling of the face, fingers, or lower legs
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
Less common
- Bone pain
- changes in skin color, pain, tenderness, or swelling of the foot or leg
- chest pain
- drowsiness
- mood or mental changes
- muscle pain or cramps
- muscle spasms or twitching
- numbness or tingling in the hands, feet, or lips
- seizures
- swollen glands
- trembling
Rare
- Abdominal or stomach cramps
- blurred vision
- dizziness
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
- weakness or heaviness of the legs
Incidence not known
- Agitation
- back, leg, or stomach pain
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blistering, peeling, or loosening of the skin
- bloody urine
- bruising
- dark urine
- diarrhea
- fast, weak pulse
- feeling faint, dizzy, or lightheaded
- flushing or redness of the skin, especially on the face and neck
- general body swelling
- hives or itching
- hostility or irritability
- joint pain
- light-colored stools
- nosebleeds
- persistent bleeding or oozing from puncture sites, mouth, or nose
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- skin rash or redness
- sweating
- vomiting of blood
- yellow eyes or skin
Other side effects of Mycamine
Some side effects of micafungin 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
- Cold sweats
- cool, pale skin
- depression
- increased hunger
- nightmares
- slurred speech
- trouble sleeping
- welts
Less common
- Bluish color
- feeling unusually cold or shivering
Rare
- Belching
- change in taste
- confusion as to time, place, or person
- difficulty having a bowel movement (stool)
- hallucinations
- heartburn
- hiccups
- sleepiness or unusual drowsiness
- stomach discomfort or upset
- unusual excitement, nervousness, or restlessness
For Healthcare Professionals
Applies to micafungin: intravenous powder for injection.
General
In clinical trials with this drug, 91% of adult patients reported at least 1 side effect.
Candidemia and other Candida infections: During 1 study, side effects were reported in 92% of patients treated with 100 mg/day. These included gastrointestinal disorders (41%), metabolism and nutrition disorders (39%), general disorders/administration site conditions (30%), investigations (18%), and cardiac disorders (18%). During another study, 93% of patients treated with 100 mg/day reported side effects, including nausea, diarrhea, vomiting, abnormal liver tests, increased AST, and increased blood alkaline phosphatase.
Esophageal candidiasis: During 1 study, 78% of patients treated with 150 mg/day reported a side effect. These included gastrointestinal disorders (32%), vascular disorders (21%), general disorders/administration site conditions (20%), nervous system disorders (16%), and skin and subcutaneous tissue disorders (14%). This drug was discontinued due to side effects in 7% of patients.
Prophylaxis of Candida infections in hematopoietic stem cell transplant (HSCT) recipients: During 1 study, all adult patients who received this drug (n=382) reported at least 1 side effect. These included gastrointestinal disorders (99%), blood and lymphatic system disorders (96%), skin and subcutaneous tissue disorders (67%), nervous system disorders (65%), psychiatric disorders (61%), and cardiac disorders (35%). This drug was discontinued due to side effects in 4% of patients.[Ref]
Gastrointestinal
Diarrhea was reported during the study for prophylaxis of Candida infections in HSCT recipients (77%), the studies for candidemia and other Candida infections (up to 11%), and the study for esophageal candidiasis (10%).
Nausea was reported during the study for prophylaxis of Candida infections in HSCT recipients (71%), the studies for candidemia and other Candida infections (up to 10%), and the study for esophageal candidiasis (8%).
Vomiting was reported during the study for prophylaxis of Candida infections in HSCT recipients (66%), the studies for candidemia and other Candida infections (up to 13%), and the study for esophageal candidiasis (7%).
Abdominal pain (26%) was reported during the study for prophylaxis of Candida infections in HSCT recipients.
A 73-year-old male presented with upper abdominal tenderness after 3 weeks of treatment with this drug (150 mg/day) for pulmonary aspergillosis accompanied by Mycobacterium avium complex infection. Laboratory findings, magnetic resonance imaging, and upper abdominal tenderness were consistent with acute pancreatitis. After stopping all drugs, his symptoms improved with bowel rest and parenteral nutrition.[Ref]
Very common (10% or more): Diarrhea (up to 77%), nausea (up to 71%), vomiting (up to 66%), abdominal pain (up to 26%), constipation (up to 11.1%)
Uncommon (0.1% to 1%): Dyspepsia
Frequency not reported: Upper abdominal pain, hiccups, acute pancreatitis[Ref]
Hematologic
Neutropenia (75%) and thrombocytopenia (75%) were reported during the study for prophylaxis of Candida infections in HSCT recipients.[Ref]
Very common (10% or more): Neutropenia (up to 75%), thrombocytopenia (up to 75%)
Common (1% to 10%): Anemia, leukopenia, febrile neutropenia
Uncommon (0.1% to 1%): Pancytopenia, eosinophilia, hypoalbuminemia
Rare (0.01% to 0.1%): Hemolysis, hemolytic anemia
Frequency not reported: Coagulopathy, thrombotic thrombocytopenic purpura, aggravated anemia, acute intravascular hemolysis
Postmarketing reports: Disseminated intravascular coagulation, decreased WBC count, hemolytic anemia, intravascular hemolysis[Ref]
Nervous system
Very common (10% or more): Headache (up to 44%)
Uncommon (0.1% to 1%): Dysgeusia, somnolence, dizziness, tremor
Frequency not reported: Convulsions, encephalopathy, intracranial hemorrhage[Ref]
Headache was reported during the study for prophylaxis of Candida infections in HSCT recipients (44%) and the study for esophageal candidiasis (9%).[Ref]
Psychiatric
Insomnia (37%) and anxiety (22%) were reported during the study for prophylaxis of Candida infections in HSCT recipients.[Ref]
Very common (10% or more): Insomnia (up to 37%), anxiety (up to 22%)
Uncommon (0.1% to 1%): Confusion
Frequency not reported: Delirium[Ref]
Cardiovascular
Tachycardia (26%) was reported during the study for prophylaxis of Candida infections in HSCT recipients.
Phlebitis (19%) was reported during the study for esophageal candidiasis.
Atrial fibrillation (3%) was reported during the studies for candidemia and other Candida infections.[Ref]
Very common (10% or more): Tachycardia (up to 26%), phlebitis (up to 19%)
Common (1% to 10%): Atrial fibrillation, hypertension, hypotension
Uncommon (0.1% to 1%): Palpitations, bradycardia
Frequency not reported: Cardiac arrest, myocardial infarction, pericardial effusion, arrhythmia, cyanosis, deep venous thrombosis
Postmarketing reports: Shock[Ref]
Dermatologic
Very common (10% or more): Rash (up to 25%)
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Urticaria, erythema
Frequency not reported: Toxic skin eruption, erythema multiforme, decubitus ulcer, skin necrosis
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]
Rash was reported during the study for prophylaxis of Candida infections in HSCT recipients (25%) and the study for esophageal candidiasis (5%).[Ref]
Other
Very common (10% or more): Pyrexia (up to 20%), mucosal inflammation (up to 14.2%)
Common (1% to 10%): Rigors, peripheral edema, fatigue, bacteremia, sepsis
Uncommon (0.1% to 1%): Flushing, increased blood lactate dehydrogenase
Frequency not reported: Infusion reaction (possible histamine-mediated symptoms including rash, pruritus, facial swelling, vasodilatation), infection, fever, septic shock[Ref]
Pyrexia (13%) was reported during the study for esophageal candidiasis.[Ref]
Metabolic
Very common (10% or more): Hypomagnesemia (up to 18%), hypokalemia (up to 13.3%)
Common (1% to 10%): Hypoglycemia, hypernatremia, hyperkalemia, hypocalcemia, anorexia, hyperglycemia, fluid overload
Uncommon (0.1% to 1%): Hyponatremia, hypophosphatemia
Frequency not reported: Acidosis, decreased appetite, fluid retention[Ref]
Hypoglycemia (6%), hyperkalemia (5%), and hypernatremia (4%) were reported during the studies for candidemia and other Candida infections.[Ref]
Hepatic
Increased blood alkaline phosphatase (6%), abnormal liver tests (4%), and increased AST (3%) were reported during the studies for candidemia and other Candida infections.[Ref]
Common (1% to 10%): Increased blood alkaline phosphatase, abnormal liver tests/liver function test abnormal, increased AST, increased ALT, increased blood bilirubin (including hyperbilirubinemia)
Uncommon (0.1% to 1%): Hepatomegaly, jaundice, hepatic failure, increased GGT, cholestasis, hepatitis
Frequency not reported: Hepatocellular damage (including fatal cases), increased hepatic enzyme, increased transaminases, worsening hepatic failure
Postmarketing reports: Hepatic disorder, hyperbilirubinemia, abnormal hepatic function, hepatocellular damage[Ref]
Respiratory
Common (1% to 10%): Cough, dyspnea, epistaxis
Frequency not reported: Pneumonia, apnea, hypoxia, pulmonary embolism[Ref]
Musculoskeletal
Common (1% to 10%): Back pain
Frequency not reported: Arthralgia[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity, anaphylactic/anaphylactoid reaction
Frequency not reported: Possible histamine-mediated symptoms (including rash, pruritus, facial swelling, vasodilatation), serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock)
Postmarketing reports: Anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock[Ref]
Renal
In controlled trials, the incidence of drug-related renal adverse events was 0.4%.[Ref]
Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, aggravated renal failure
Frequency not reported: Elevations in BUN and serum creatinine, anuria, oliguria, renal tubular necrosis
Postmarketing reports: Renal impairment, acute renal failure[Ref]
Local
Uncommon (0.1% to 1%): Injection site thrombosis, infusion site inflammation, injection site pain
Frequency not reported: Injection site reactions (including phlebitis, thrombophlebitis)[Ref]
Injection site reactions have been reported with doses of 50 to 150 mg per day. These reactions occurred more often with peripheral IV administration.[Ref]
Endocrine
Uncommon (0.1% to 1%): Hyperhidrosis[Ref]
Genitourinary
Frequency not reported: Hemoglobinuria
