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

General

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%).

Cardiovascular

Common (1% to 10%): Tachycardia, palpitations, acute coronary syndrome, angina pectoris, arrhythmia, bradycardia, ventricular extrasystoles, hematoma, hypertension, hot flush, hypotension, chest pain, general edema

Dermatologic

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

Gastrointestinal

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

Genitourinary

Common (1% to 10%): Dysuria

Hematologic

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

Hepatic

Frequency not reported: Elevated transaminases

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Metabolic

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%)

Musculoskeletal

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

Nervous system

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

Ocular

Common (1% to 10%): Cataract, blurred vision, conjunctival hemorrhage, dry eye, increased lacrimation, conjunctivitis, diplopia, eye pain, eyelid edema

Other

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

Psychiatric

Very common (10% or more): Insomnia (10%)
Common (1% to 10%): Anxiety, depression, agitation, confusional state, mental status change

Respiratory

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

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.