Summary

Commonly reported side effects of romiplostim include: abdominal pain, dizziness, insomnia, limb pain, and myalgia. Other side effects include: dyspepsia, paresthesia, and shoulder pain. Continue reading for a comprehensive list of adverse effects.

Applies to romiplostim: parenteral powder for injection.

Side effects include:

Most common adverse reactions in adults receiving romiplostim in clinical studies (≥5% higher patient incidence than placebo) were arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia.

Most common adverse reactions in pediatric patients receiving romiplostim in clinical studies (≥25%) were contusion, upper respiratory tract infection, and oropharyngeal pain.

For Healthcare Professionals

Applies to romiplostim: subcutaneous powder for injection.

General

The most serious adverse reactions were increased bone marrow reticulin, thrombotic/thromboembolic complications, and progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML).^[Ref]

Hematologic

Serious bleeding events included any event that was fatal, life-threatening, required hospitalization or prolongation of hospitalization, caused persistent or significant disability/incapacity, congenital anomaly/birth defect, and any other significant hazard.^[Ref]

Very common (10% or more): Grade 2 or higher bleeding event (15%)

Common (1% to 10%): Bone marrow reticulin formation increased 2 grades or more, bone marrow collagen fibrosis increased to grade 4, grade 4 bone marrow collagen fibrosis, bone marrow disorder, thrombocytopenia, anemia, thrombocytosis, bone marrow reticulin deposition, anemia, reticulin increased, serious bleeding event

Uncommon (0.1% to 1%): Aplastic anemia, bone marrow failure, leukocytosis, splenomegaly, thrombocythemia, platelet count increased, platelet count abnormal, blood lactate dehydrogenase increased

Frequency not reported: Marrow fibrosis with collagen^[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, flushing, hematoma, hypertension, peripheral ischemia, peripheral embolism

Uncommon (0.1% to 1%): Myocardial infarction, heart rate increased, deep vein thrombosis, hypotension, phlebitis, thrombophlebitis superficial, thrombosis, erythromelalgia, blood pressure increased

Frequency not reported: Congestive heart failure^[Ref]

Oncologic

Common (1% to 10%): B-cell lymphoma

Uncommon (0.1% to 1%): Multiple myeloma, myelofibrosis

Frequency not reported: Progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML), blast cell counts transiently increased^[Ref]

Nervous system

Very common (10% or more): Headache (up to 36.2%), dizziness (up to 17%)

Common (1% to 10%): Paresthesia, migraine

Uncommon (0.1% to 1%): Clonus, dysgeusia, hypoesthesia, hypogeusia, neuropathy peripheral, transverse sinus thrombosis, vertigo^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 31%), nasopharyngitis (up to 26.2%), oropharyngeal pain (up to 25%), epistaxis (22.6%), cough (up to 17.3%)

Common (1% to 10%): Pulmonary embolism, sinusitis, bronchitis, dyspnea, nasal congestion, rhinorrhea

Uncommon (0.1% to 1%): Dry throat, painful respiration

Frequency not reported: Upper respiratory tract infection, pneumonia^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 26%), back pain (up to 15.8%), pain in extremity (up to 15.6%), myalgia (up to 14%)

Common (1% to 10%): Shoulder pain, muscle spasms, bone pain, musculoskeletal pain

Uncommon (0.1% to 1%): Muscle tightness, muscle weakness, muscle twitching^[Ref]

Other

Very common (10% or more): Contusion (up to 41%), pyrexia (up to 24%), fatigue (up to 23.3%)

Common (1% to 10%): Influenza-like illness, pain, asthenia, chills, injection site reaction, chest pain, peripheral swelling

Uncommon (0.1% to 1%): Injection site hemorrhage, malaise, feeling hot, feeling jittery, body temperature increased^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%), nausea (up to 19.4%), upper abdominal pain (14%), abdominal pain (up to 11%), vomiting (up to 10.5%)

Common (1% to 10%): Dyspepsia, gastroenteritis, constipation, gingival bleeding, mouth hemorrhage, upper abdominal pain, toothache

Uncommon (0.1% to 1%): Rectal hemorrhage, breath odor, dysphagia, gastroesophageal reflux disease, hematochezia, stomach discomfort, stomatitis, tooth discoloration^[Ref]

Dermatologic

Very common (10% or more): Petechiae (18.6%), rash (up to 15%)

Common (1% to 10%): Angioedema, pruritus, ecchymosis, purpura, urticaria

Uncommon (0.1% to 1%): Alopecia, photosensitivity reaction, acne, dermatitis contact, dry skin, eczema, erythema, exfoliative rash, hair growth abnormal, prurigo, rash papular, rash pruritic, skin nodule, skin odor abnormal, face edema^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 16%)

Common (1% to 10%): Anxiety

Uncommon (0.1% to 1%): Depression, abnormal dreams, irritability^[Ref]

Metabolic

Very common (10% or more): Peripheral edema (up to 12.5%)

Common (1% to 10%): Hypokalemia

Uncommon (0.1% to 1%): Alcohol intolerance, anorexia, appetite decreased, dehydration, gout, weight decreased, weight increased^[Ref]

Immunologic

Very common (10% or more): Antibodies to this drug (up to 16%)

Common (1% to 10%): Preexisting antibodies to this drug, influenza, ear infection

Uncommon (0.1% to 1%): Localized infection, neutralizing antibodies

Frequency not reported: Hypersensitivity reactions including angioedema and anaphylaxis (postmarketing reports)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Protein urine present, vaginal hemorrhage^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctival hemorrhage, accommodation disorder, blindness, eye disorder, eye pruritus, lacrimation increased, papilledema, visual disturbances^[Ref]

Hepatic

Uncommon (0.1% to 1%): Portal vein thrombosis, transaminase increased^[Ref]