Drug · FAERS side-effect profile with label screen
Romiplostim side effects: what 14,966 FDA adverse event reports show
Drug class
Thrombopoietin Receptor Agonist
FDA label (Established Pharmacologic Class)
Brand names
Nplate
openFDA label
Who reports
14,966 reports · 77% serious · 2,626 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
FDA label, Indications and Usage
What it is
Romiplostim is a thrombopoietin receptor agonist (TPO-RA). Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). The peptibody molecule contains two iden.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 4Likely indication confounding 10Lab value / disease marker 3Not in label — unassessed 22
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 981 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Reticulin increased | 17 | 1,174.2 615.2–2,241.2ROR 1,175.6 · χ² 10,147 / p <1e-300 | 370.1 EB05 244.7 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Bone marrow reticulin fibrosis | 117 | 1,130.3 885.7–1,442.4ROR 1,139.2 · χ² 71,986 / p <1e-300 | 564.3 EB05 483.6 · IC025 +7.1 3/3 methods agree | Labeled (related wording) related wording | serious n=117 · 92% clinician | no trial data cached |
| Biopsy bone marrow abnormal | 90 | 342.5 272.1–431.2ROR 344.6 · χ² 24,285 / p <1e-300 | 259.5 EB05 217.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=88 | no trial data cached |
| Coombs positive haemolytic anaemia | 89 | 333.2 264.5–419.7ROR 335.2 · χ² 23,482 / p <1e-300 | 254.0 EB05 212.7 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=89 · ♀ 0% (drug 54%) · 99% clinician | no trial data cached |
| Mucocutaneous haemorrhage | 24 | 285.8 184.2–443.5ROR 286.3 · χ² 5,410 / p <1e-300 | 199.5 EB05 141.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Platelet count abnormal | 958 | 265.1 247.8–283.5ROR 283.1 · χ² 211,284 / p <1e-300 | 221.6 EB05 210.0 · IC025 +7.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=639 | no trial data cached |
| Splenectomy | 137 | 187.4 156.9–223.8ROR 189.1 · χ² 22,202 / p <1e-300 | 161.4 EB05 140.0 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications | serious n=136 | no trial data cached |
| Megakaryocytes increased | 14 | 174.2 100.0–303.7ROR 174.4 · χ² 1,990 / p <1e-300 | 128.2 EB05 81.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Evans syndrome | 47 | 151.7 112.3–204.9ROR 152.2 · χ² 6,205 / p <1e-300 | 129.7 EB05 101.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=47 | no trial data cached |
| Thrombocytosis | 328 | 138.3 123.6–154.8ROR 141.4 · χ² 40,527 / p <1e-300 | 124.9 EB05 114.0 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=323 | no trial data cached |
| Myeloproliferative disorder | 14 | 84.8 49.5–145.5ROR 84.9 · χ² 1,015 / p 5e-223 | 72.4 EB05 45.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Anti-platelet antibody positive | 10 | 84.8 44.8–160.5ROR 84.8 · χ² 703 / p 4e-155 | 69.7 EB05 40.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Cellulitis gangrenous | 11 | 82.1 44.7–150.9ROR 82.2 · χ² 757 / p 5e-167 | 68.7 EB05 41.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Idiopathic thrombocytopenic purpura | 85 | 78.4 63.1–97.5ROR 78.9 · χ² 6,077 / p <1e-300 | 73.1 EB05 61.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=85 · 94% clinician | no trial data cached |
| Myelofibrosis | 156 | 76.1 64.8–89.3ROR 76.9 · χ² 10,884 / p <1e-300 | 71.5 EB05 62.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=154 | no trial data cached |
| Thrombocytopenia neonatal | 20 | 70.7 45.1–110.7ROR 70.8 · χ² 1,241 / p 3e-272 | 63.4 EB05 43.3 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=20 | no trial data cached |
| Immune thrombocytopenia | 203 | 66.6 57.9–76.6ROR 67.5 · χ² 12,447 / p <1e-300 | 63.2 EB05 56.2 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications | serious n=202 · 92% clinician | no trial data cached |
| Neutralising antibodies positive | 18 | 64.4 40.2–103.3ROR 64.5 · χ² 1,014 / p 8e-223 | 58.0 EB05 38.8 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Mucosal haemorrhage | 44 | 55.6 41.1–75.1ROR 55.7 · χ² 2,214 / p <1e-300 | 52.3 EB05 40.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=44 · 100% clinician | no trial data cached |
| Lymphadenitis | 91 | 54.8 44.5–67.5ROR 55.1 · χ² 4,570 / p <1e-300 | 52.2 EB05 43.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=91 · ♀ 0% (drug 54%) · 97% clinician | no trial data cached |
| Marrow hyperplasia | 25 | 52.8 35.4–78.7ROR 52.9 · χ² 1,175 / p 1e-257 | 49.1 EB05 35.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=24 · 92% clinician | no trial data cached |
| Platelet count | 20 | 50.0 32.0–78.0ROR 50.0 · χ² 879 / p 1e-193 | 46.3 EB05 31.6 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=8 | no trial data cached |
| Chronic myelomonocytic leukaemia | 21 | 45.6 29.5–70.4ROR 45.7 · χ² 844 / p 6e-186 | 42.6 EB05 29.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Platelet count increased | 398 | 44.0 39.9–48.6ROR 45.2 · χ² 16,177 / p <1e-300 | 42.6 EB05 39.2 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 33.1 | no trial data cached |
| Embolism arterial | 33 | 39.5 28.0–55.8ROR 39.6 · χ² 1,167 / p 5e-256 | 37.7 EB05 28.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | no trial data cached |
| Blast cells present | 12 | 36.0 20.3–63.8ROR 36.0 · χ² 364 / p 2e-81 | 33.4 EB05 20.3 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Petechiae | 253 | 34.9 30.8–39.5ROR 35.5 · χ² 8,098 / p <1e-300 | 34.0 EB05 30.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 | no trial data cached |
| Cerebral venous sinus thrombosis | 19 | 33.2 21.1–52.4ROR 33.3 · χ² 549 / p 1e-121 | 31.5 EB05 21.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Paroxysmal nocturnal haemoglobinuria | 10 | 31.1 16.6–58.2ROR 31.1 · χ² 256 / p 5e-58 | 28.9 EB05 16.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Immune thrombocytopenic purpura | 61 | 30.4 23.6–39.2ROR 30.5 · χ² 1,669 / p <1e-300 | 29.5 EB05 23.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=60 | no trial data cached |
| Monocytosis | 13 | 30.0 17.3–52.0ROR 30.1 · χ² 329 / p 7e-74 | 28.3 EB05 17.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Antiphospholipid syndrome | 33 | 29.5 20.9–41.6ROR 29.6 · χ² 862 / p 1e-189 | 28.5 EB05 21.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=33 | no trial data cached |
| Platelet disorder | 51 | 28.8 21.8–38.0ROR 28.9 · χ² 1,313 / p 1e-287 | 28.0 EB05 22.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=29 | no trial data cached |
| Haematological malignancy | 52 | 26.2 19.9–34.4ROR 26.2 · χ² 1,211 / p 2e-265 | 25.5 EB05 20.2 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=51 · ♀ 26% (drug 54%) · 96% clinician | no trial data cached |
| Non-hodgkin's lymphoma | 24 | 25.7 17.2–38.5ROR 25.8 · χ² 536 / p 8e-119 | 24.8 EB05 17.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Bone marrow disorder | 54 | 25.6 19.5–33.4ROR 25.7 · χ² 1,228 / p 3e-269 | 24.9 EB05 19.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=54 | no trial data cached |
| Myelodysplastic syndrome | 246 | 24.2 21.4–27.4ROR 24.6 · χ² 5,360 / p <1e-300 | 23.8 EB05 21.4 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.0 · 97% clinician | no trial data cached |
| Cerebral venous thrombosis | 30 | 23.4 16.3–33.6ROR 23.5 · χ² 611 / p 3e-135 | 22.7 EB05 16.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 81% (drug 54%) · 100% clinician | no trial data cached |
| Platelet count decreased | 1,743 | 23.3 22.3–24.4ROR 26.2 · χ² 36,737 / p <1e-300 | 22.9 EB05 22.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.0 | no trial data cached |
| Chronic lymphocytic leukaemia | 75 | 22.4 17.8–28.1ROR 22.5 · χ² 1,486 / p <1e-300 | 21.9 EB05 18.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=75 · 96% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,750 | 1.9 1.8–1.9ROR 2.0 · χ² 745 / p 3e-164 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.6 · 90% clinician | no trial data cached |
| Platelet count decreased | 1,743 | 23.3 22.3–24.4ROR 26.2 · χ² 36,737 / p <1e-300 | 22.9 EB05 22.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.0 | no trial data cached |
| Off label use (used outside approved label) | 1,248 | 2.0 1.9–2.1ROR 2.1 · χ² 665 / p 7e-147 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Death | 1,005 | 1.6 1.5–1.7ROR 1.7 · χ² 258 / p 3e-58 | 1.6 EB05 1.6 · IC025 +0.6 | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Thrombocytopenia (low platelets) | 1,004 | 12.7 12.0–13.5ROR 13.6 · χ² 10,789 / p <1e-300 | 12.6 EB05 12.0 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.7 | no trial data cached |
| Platelet count abnormal | 958 | 265.1 247.8–283.5ROR 283.1 · χ² 211,284 / p <1e-300 | 221.6 EB05 210.0 · IC025 +7.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=639 | no trial data cached |
| Therapeutic response decreased | 942 | 22.2 20.9–23.6ROR 23.6 · χ² 18,819 / p <1e-300 | 21.9 EB05 20.7 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 40.0 · 92% clinician | no trial data cached |
| Headache | 605 | 1.4 1.3–1.5ROR 1.4 · χ² 57 / p 2e-14 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Fatigue (tiredness) | 471 | 0.8 0.8–0.9ROR 0.8 · χ² 13 / p 2e-4 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Platelet count increased | 398 | 44.0 39.9–48.6ROR 45.2 · χ² 16,177 / p <1e-300 | 42.6 EB05 39.2 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 33.1 | no trial data cached |
| Hospitalisation | 388 | 3.6 3.2–3.9ROR 3.6 · χ² 720 / p 7e-159 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Haemorrhage | 387 | 5.2 4.7–5.7ROR 5.3 · χ² 1,311 / p 3e-287 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Arthralgia (joint pain) | 356 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Nausea | 345 | 0.6 0.6–0.7ROR 0.6 · χ² 87 / p 4e-21 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | no trial data cached |
| Product storage error | 345 | 5.6 5.0–6.2ROR 5.7 · χ² 1,300 / p 4e-285 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 0.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Biopsy bone marrow abnormal — n=90, PRR 342.5
- Mucocutaneous haemorrhage — n=24, PRR 285.8
- Evans syndrome — n=47, PRR 151.7
- Idiopathic thrombocytopenic purpura — n=85, PRR 78.4
- Myelofibrosis — n=156, PRR 76.1
- Mucosal haemorrhage — n=44, PRR 55.6
- Lymphadenitis — n=91, PRR 54.8
- Marrow hyperplasia — n=25, PRR 52.8
- Chronic myelomonocytic leukaemia — n=21, PRR 45.6
- Embolism arterial — n=33, PRR 39.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Romiplostim?
In FDA FAERS, the most frequently co-reported reaction terms for Romiplostim are platelet count decreased, thrombocytopenia, platelet count abnormal, headache, fatigue, platelet count increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Romiplostim have an FDA boxed warning?
No. The FDA label retrieved for Romiplostim has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Romiplostim causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID c45f9a58-37c1-4f76-8e36-97d38c577037, effective 20260623; matched on
openfda.generic_name.exact:"ROMIPLOSTIM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,021 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.