Mycamine Side Effects

Generic name: micafungin

Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.

Note: This document provides detailed information about Mycamine.

Applies to micafungin: intravenous powder for solution Side Effects associated with micafungin. Some dosage forms listed on this page may not apply specifically to the brand name Mycamine.

Applies to micafungin: intravenous powder for solution.

Precautions

It is very important that your doctor check your or your child's progress closely to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have blurred vision, chest tightness, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hoarseness, redness of the skin, skin rash, itching, hives or welts, sweating, swelling of your hands, face, or mouth, trouble breathing or swallowing, or unusual tiredness or weakness after you receive this medicine.

This medicine may cause blood problems (eg, hemolysis, hemolytic anemia). Check with your doctor right away if you have back, leg, or stomach pain, bleeding gums, chills, dark urine, decreased urination, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, tiredness, trouble breathing, or yellow eyes or skin.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

This medicine may cause infusion and injection site reactions (eg, phlebitis, thrombophlebitis), which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have changes in skin color, difficulty with swallowing, dizziness, fast heartbeat, chest tightness, flushing, sweating, swelling in your face, hands, foot, or leg, lightheadedness or faintness while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to micafungin: intravenous powder for injection, intravenous solution.

General adverse events

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

• 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]

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]

Hematologic

• 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]

Neutropenia (75%) and thrombocytopenia (75%) were reported during the study for prophylaxis of Candida infections in HSCT recipients.^[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

• Very common (10% or more): Insomnia (up to 37%), anxiety (up to 22%)
• Uncommon (0.1% to 1%): Confusion
• Frequency not reported: Delirium^[Ref]

Insomnia (37%) and anxiety (22%) were reported during the study for prophylaxis of Candida infections in HSCT recipients.^[Ref]

Cardiovascular

• 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]

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]

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

• 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]

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]

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

• 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]

In controlled trials, the incidence of drug-related renal adverse events was 0.4%.^[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

See also:

Further information

Mycamine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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