Nplate Side Effects
Generic name: romiplostim
Note: This document contains side effect information about romiplostim. Some dosage forms listed on this page may not apply to the brand name Nplate.
Applies to romiplostim: subcutaneous powder for solution.
Serious side effects of Nplate
Along with its needed effects, romiplostim (the active ingredient contained in Nplate) 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
- 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 Nplate
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
- 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
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]
Frequently asked questions
- How long does Nplate (romiplostim) take to work?
- Is Nplate a chemotherapy drug?
- How is Nplate (romiplostim) administered?
- What is Nplate used for and how does it work?
- Does Nplate cause hair loss?
More about Nplate (romiplostim)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (9)
- Drug images
- Dosage information
- Patient tips
- During pregnancy
- FDA approval history
- Drug class: platelet-stimulating agents
- Breastfeeding
- En español
Patient resources
Professional resources
Related treatment guides
References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Cerner Multum, Inc. Australian Product Information.
3. Product Information. Nplate (romiplostim). Amgen USA. 2008.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.