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Romiplostim Side Effects

For the Consumer

Applies to romiplostim: subcutaneous powder for solution

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:

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty with breathing
  • pain in the chest, groin, or legs, especially the calves
  • pinpoint red spots on the skin
  • severe, sudden headache
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • unusual bleeding or bruising
  • vision changes

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
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • dizziness
  • headache
  • heartburn
  • indigestion
  • muscle aching or cramping
  • muscle pains or stiffness
  • pain in the arms or legs
  • pain in the joints
  • pain in the shoulder
  • stomach discomfort, upset, or pain
  • swollen joints
  • trouble sleeping

For Healthcare Professionals

Applies to romiplostim: subcutaneous powder for injection


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]


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]


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]


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]


Very common (10% or more): Nasopharyngitis (up to 26.2%), epistaxis (22.6%), upper respiratory tract infection (18.2%), cough (up to 17.3%), oropharyngeal pain (12.2%)
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]


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]


Very common (10% or more): Fatigue (up to 23.3%), contusion (up to 22.5%), pyrexia (up to 11.8%)
Common (1% to 10%): Influenza-like illness, pain, asthenia, chills, injection site reaction, chest pain
Uncommon (0.1% to 1%): Injection site hemorrhage, malaise, feeling hot, feeling jittery, body temperature increased[Ref]


Very common (10% or more): Nausea (up to 19.4%), diarrhea (up to 18.7%), 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]


Very common (10% or more): Petechiae (18.6%), rash (up to 11.3%)
Common (1% to 10%): Angioedema, pruritus, ecchymosis
Uncommon (0.1% to 1%): Alopecia, photosensitivity reaction, acne, dermatitis contact, dry skin, eczema, erythema, exfoliative rash, hair growth abnormal, prurigo, purpura, rash papular, rash pruritic, skin nodule, skin odor abnormal, urticaria, face edema[Ref]


Very common (10% or more): Insomnia (up to 16%)
Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Depression, abnormal dreams, irritability[Ref]


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]


Common (1% to 10%): Antibodies to this drug, preexisting antibodies to this drug, influenza
Uncommon (0.1% to 1%): Localized infection, neutralizing antibodies
Frequency not reported: Hypersensitivity[Ref]


Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Protein urine present, vaginal hemorrhage[Ref]


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


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


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Nplate (romiplostim)." Amgen USA, Thousand Oaks, CA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Some side effects of romiplostim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.