Romiplostim Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 15, 2024.

Applies to romiplostim: subcutaneous powder for solution.

Serious side effects of romiplostim

Along with its needed effects, romiplostim 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 romiplostim:

More common side effects

• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• change in hearing
• chills
• cough
• diarrhea
• difficulty breathing
• ear congestion, drainage, or pain
• fever
• headache
• loss of appetite
• loss of voice
• nausea
• pain or tenderness around the eyes and cheekbones
• rapid weight gain
• sneezing
• sore throat
• stomach pain
• stuffy or runny nose
• tightness of the chest
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• upper stomach pain

Incidence not known

• burning pain, warmth, swelling, or redness of the hands and feet
• fast heartbeat
• feeling of warmth
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• redness of the skin
• trouble swallowing

Other side effects of romiplostim

Some side effects of romiplostim 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:

More common side effects

• acid or sour stomach
• belching
• bruise
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty with moving
• dizziness
• heartburn
• indigestion
• mouth or throat pain
• muscle pains, cramps, or stiffness
• pain in the shoulder, arms, or legs
• stomach discomfort, upset, or pain
• trouble sleeping

For healthcare professionals

Applies to romiplostim: subcutaneous powder for injection.

General adverse events

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

• 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]

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]

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]

Frequently asked questions

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Further information

Romiplostim 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.

Medical Disclaimer