Synribo Side Effects
Generic name: omacetaxine
Note: This document contains side effect information about omacetaxine. Some of the dosage forms listed on this page may not apply to the brand name Synribo.
Some side effects of Synribo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Applies to omacetaxine: subcutaneous powder for injection
The most common side effects (frequency greater than and equal to 20%) include thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia.
Serious side effects occurring in at least 5% of patients included febrile neutropenia (18%), thrombocytopenia (9%), anemia (7%), diarrhea (6%), and convulsions (6%).
The most common side effects leading to withdrawal were leukocytosis (6%) and thrombocytopenia (4%).
Common (1% to 10%): Tachycardia, palpitations, acute coronary syndrome, angina pectoris, arrhythmia, bradycardia, ventricular extrasystoles, hematoma, hypertension, hot flush, hypotension, chest pain, general edema
Very common (10% or more): Alopecia (15%), rash (10%)
Common (1% to 10%): Erythema, pruritus, dry skin, petechiae, hyperhidrosis, night sweats, ecchymosis, purpura, skin lesion, skin ulcer, rash erythematous, rash papular, skin exfoliation, skin hyperpigmentation
Very common (10% or more): Diarrhea (up to 42%), nausea (up to 32%), constipation (15%), abdominal pain (up to 14%), vomiting (up to 15%)
Common (1% to 10%): Stomatitis, mouth ulceration, abdominal distension, dyspepsia, gastroesophageal reflux disease, gingival bleeding, aphthous stomatitis, dry mouth, hemorrhoids, gastritis, gastrointestinal hemorrhage, melena, mouth hemorrhage, oral pain, anal fissure, dysphagia, gingival pain, gingivitis
Common (1% to 10%): Dysuria
Very common (10% or more): Thrombocytopenia (up to 74%), anemia (up to 61%), neutropenia (up to 50%), lymphopenia (17%), bone marrow failure (10%), febrile neutropenia (up to 20%)
Common (1% to 10%): Transfusion reaction
Frequency not reported: Pancytopenia, bone marrow necrosis
Frequency not reported: Elevated transaminases
Common (1% to 10%): Hypersensitivity
Very common (10% or more: Anorexia (13%)
Common (1% to 10%): Decreased appetite, diabetes mellitus, gout, dehydration
Frequency not reported: Hyperosmolar nonketotic hyperglycemia
Laboratory abnormalities (Grade 3 or 4): platelets decreased (up to 88%), neutrophils decreased (up to 81%), hemoglobin decreased (up to 80%), leukocytes decreased (up to 72%), uric acid increased (up to 57%), creatinine increased (up to 16%), glucose increased (up to 15%), bilirubin increased (up to 9%), glucose decreased (up to 8%), alanine aminotransferase (ALT) increased (up to 6%)
Very common (10% or more): Arthralgia (19%), pain in extremity (up to 13%), back pain (11%)
Common (1% to 10%): Bone pain, myalgia, muscular weakness, muscle spasms, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, musculoskeletal discomfort
Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Dizziness, cerebral hemorrhage, paresthesia, convulsion, hypoesthesia, lethargy, sciatica, burning sensation, dysgeusia, tremor
Frequency not reported: Cerebral hemorrhage
Common (1% to 10%): Cataract, blurred vision, conjunctival hemorrhage, dry eye, increased lacrimation, conjunctivitis, diplopia, eye pain, eyelid edema
Very common (10% or more): Infections (bacterial, viral, fungal and nonspecified) and infestations (up to 56%), infusion and injection site related reactions (up to 34%), fatigue (up to 31%), pyrexia (up to 29%), asthenia (up to 24%), peripheral edema (13%), chills (13%)
Common (1% to 10%): Ear pain, ear hemorrhage, tinnitus, mucosal inflammation, pain, hyperthermia, influenza-like illness, catheter site pain, malaise, contusion
Frequency not reported: Multi-organ failure
Very common (10% or more): Insomnia (10%)
Common (1% to 10%): Anxiety, depression, agitation, confusional state, mental status change
Very common (10% or more): Cough (up to 16%), epistaxis (up to 15%), dyspnea (11%)
Common (1% to 10%): Pharyngolaryngeal pain, nasal congestion, dysphonia, productive cough, rales, rhinorrhea, hemoptysis, sinus congestion
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