Mycamine Side Effects

Please note - some side effects for Mycamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Mycamine - for the Consumer

Mycamine

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mycamine:

Back pain; constipation; cough; diarrhea; fatigue; headache; indigestion; loss of appetite; mild nosebleed; nausea; sore mouth; stomach pain; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; blood in the urine; change in the amount of urine produced; chest pain; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; muscle pain or cramps; redness, tenderness, pain, or swelling near the injection site; seizures; severe or persistent dizziness or headache; shortness of breath; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, flushing, increased thirst or urination, rapid breathing, unusual drowsiness); unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

Mycamine Side Effects - for the Professional

Mycamine

• Most common adverse reactions include diarrhea, nausea, vomiting, pyrexia, hypokalemia, thrombocytopenia, and headache (6.)
• Histamine-mediated symptoms including rash, pruritus, facial swelling, and vasodilatation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Hepatic

Hepatic side effects have included abnormal liver function tests (1% to 8%), including increased aspartate aminotransferase (5.6%), alkaline phosphatase (5.4%), and alanine aminotransferase (5.4%). Hepatitis, hyperbilirubinemia, hepatomegaly, jaundice, hepatic failure, and worsening hepatic failure have been reported. Hyperbilirubinemia, abnormal hepatic function, hepatic disorder, and hepatocellular damage have been reported during postmarketing experience.

Renal

Renal side effects have included elevations in BUN and serum creatinine, anuria, oliguria, renal tubular necrosis, hemoglobinuria, and acute renal failure. Renal impairment has been reported during postmarketing experience.

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

Hematologic

Hematologic side effects have included thrombocytopenia (less than 1% to 15.4%), neutropenia (1.2% to 14.4%), anemia (9.8%), febrile neutropenia (6.1%), anemia aggravation (2% to 5%), leukopenia (1.6%), acute intravascular hemolysis, hemoglobinuria, hemolytic anemia, coagulopathy, pancytopenia, and thrombotic thrombocytopenic purpura. Decreased white blood cell count has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects including erythema multiforme, anaphylaxis, and anaphylactoid reactions (including shock) have been reported.

Dermatologic

Dermatologic side effects have included histamine-mediated symptoms, including rash (1% to 12%), pruritus (less than 1% to 6%), decubitus ulcer (4.5% to 5.9%), facial swelling, skin necrosis, and urticaria. Erythema has been reported in 11.3% of hematopoietic stem cell transplant recipients.

Local

Local side effects have included reactions at the injection site, including phlebitis (1.6%), thrombophlebitis, and thrombosis.

Psychiatric

Psychiatric side effects have included insomnia (9.8%), anxiety (6.4%), and delirium.

Nervous system

Nervous system side effects have included headache (2% to 17%), dysgeusia, somnolence, dizziness, convulsions, encephalopathy, and intracranial hemorrhage. Dizziness has been reported in 12.9% of hematopoietic stem cell transplant recipients.

Metabolic

Metabolic side effects have included hypokalemia (1.2% to 18%), hypomagnesemia (5.5% to 13.3%), hypocalcemia (6.5%), hyponatremia (4% to 6.4%), anorexia (6.2%), hypoglycemia (5.6%), fluid overload (5%), acidosis, and hypophosphatemia. Decreased appetite has been reported in 20% of hematopoietic stem cell transplant recipients.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (1.6% to 23.3%), nausea (2% to 22%), vomiting (1% to 21.7%), constipation (11.1%), abdominal pain (1% to 9.7%), dyspepsia (5.7%), abdominal pain (upper), and hiccups. At least one case of acute pancreatitis has also been reported.

A 73-year-old male presented with upper abdominal tenderness after 3 weeks of treatment with micafungin (150 mg per 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.

Cardiovascular

Cardiovascular side effects have included hypotension (9.1%), tachycardia (7.5%), hypertension (6.9%), peripheral edema (6.8%), phlebitis (5.6%), bradycardia (2.5% to 5%), atrial fibrillation (2.5% to 5%), arrhythmia, cardiac arrest, cyanosis, myocardial infarction, and deep venous thrombosis. Shock has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included back pain (5.4%) and arthralgia.

Respiratory

Respiratory side effects have included cough (8.1%), dyspnea (5.9%), epistaxis (5.6%), pneumonia (0.5% to 5.4%), apnea, hypoxia, and pulmonary embolism.

Other

Other side effects have included pyrexia (20%), mucosal inflammation (14.2%), fever (1% to 14%), rigors (9.1%), fatigue (6.4%), septic shock (4.5% to 7.5%), bacteremia (6%), and sepsis (5.1%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.