ROMIPLOSTIM

N/A

Manufactured by Amgen, Inc

24,148 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ROMIPLOSTIM

ROMIPLOSTIM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. The most commonly reported adverse reactions for ROMIPLOSTIM include DRUG INEFFECTIVE, PLATELET COUNT DECREASED, OFF LABEL USE, DEATH, THERAPEUTIC RESPONSE DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROMIPLOSTIM.

Top Adverse Reactions

DRUG INEFFECTIVE1,700 reports
PLATELET COUNT DECREASED1,689 reports
OFF LABEL USE1,164 reports
DEATH989 reports
THERAPEUTIC RESPONSE DECREASED942 reports
PLATELET COUNT ABNORMAL939 reports
THROMBOCYTOPENIA930 reports
HEADACHE582 reports
FATIGUE455 reports
HAEMORRHAGE374 reports
PLATELET COUNT INCREASED373 reports
HOSPITALISATION369 reports
ARTHRALGIA351 reports
PRODUCT STORAGE ERROR344 reports
PNEUMONIA332 reports
NAUSEA329 reports
THROMBOCYTOSIS307 reports
DEEP VEIN THROMBOSIS292 reports
PULMONARY EMBOLISM284 reports
CONTUSION281 reports
ASTHENIA277 reports
EPISTAXIS276 reports
ANAEMIA271 reports
DIARRHOEA269 reports
THERAPY NON RESPONDER261 reports
MYELODYSPLASTIC SYNDROME246 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR240 reports
PETECHIAE239 reports
MALAISE223 reports
DIZZINESS222 reports
PYREXIA214 reports
CEREBROVASCULAR ACCIDENT211 reports
PAIN IN EXTREMITY207 reports
SEPSIS206 reports
NEUTROPENIA204 reports
DYSPNOEA187 reports
PAIN186 reports
THROMBOSIS182 reports
IMMUNE THROMBOCYTOPENIA177 reports
ABDOMINAL PAIN175 reports
MYALGIA173 reports
RASH169 reports
GASTROINTESTINAL HAEMORRHAGE166 reports
CONSTIPATION163 reports
MIGRAINE155 reports
INSOMNIA152 reports
HAEMOGLOBIN DECREASED151 reports
MYELOFIBROSIS149 reports
THERAPEUTIC PRODUCT EFFECT DECREASED148 reports
INFECTION147 reports
VOMITING145 reports
OEDEMA PERIPHERAL138 reports
FALL137 reports
SPLENECTOMY135 reports
HYPERTENSION134 reports
ACUTE MYELOID LEUKAEMIA132 reports
BACK PAIN128 reports
MYOCARDIAL INFARCTION126 reports
HEPATIC ENZYME INCREASED123 reports
DRUG EFFECT DECREASED118 reports
HAEMOLYSIS117 reports
BONE MARROW RETICULIN FIBROSIS116 reports
PLEURAL EFFUSION113 reports
PANCYTOPENIA112 reports
UNEVALUABLE EVENT109 reports
RENAL FAILURE108 reports
WEIGHT DECREASED108 reports
WHITE BLOOD CELL COUNT INCREASED108 reports
BONE PAIN106 reports
PARAESTHESIA104 reports
RESPIRATORY FAILURE100 reports
INTERCEPTED PRODUCT ADMINISTRATION ERROR99 reports
CEREBRAL HAEMORRHAGE97 reports
INFUSION RELATED REACTION97 reports
DISEASE PROGRESSION96 reports
NASOPHARYNGITIS96 reports
URINARY TRACT INFECTION94 reports
MUSCULOSKELETAL PAIN93 reports
COUGH92 reports
BIOPSY BONE MARROW ABNORMAL91 reports
LYMPHADENITIS91 reports
DECREASED APPETITE90 reports
TREATMENT FAILURE90 reports
COOMBS POSITIVE HAEMOLYTIC ANAEMIA89 reports
DRUG DOSE OMISSION89 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION89 reports
GINGIVAL BLEEDING89 reports
ATRIAL FIBRILLATION88 reports
IDIOPATHIC THROMBOCYTOPENIC PURPURA87 reports
LEUKOCYTOSIS87 reports
PURPURA86 reports
FEELING ABNORMAL84 reports
MATERNAL EXPOSURE DURING PREGNANCY84 reports
ADVERSE EVENT81 reports
CARDIAC FAILURE80 reports
CHEST PAIN80 reports
ECCHYMOSIS80 reports
HAEMORRHAGE INTRACRANIAL80 reports
INTENTIONAL PRODUCT MISUSE80 reports
PRODUCT PREPARATION ERROR80 reports

Report Outcomes

Out of 14,491 classified reports for ROMIPLOSTIM:

Serious 76.7%Non-Serious 23.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female6,290 (53.0%)
Male5,480 (46.1%)
Unknown105 (0.9%)

Reports by Age

Age 60208 reports
Age 70181 reports
Age 62179 reports
Age 74177 reports
Age 68176 reports
Age 75166 reports
Age 72165 reports
Age 76161 reports
Age 57159 reports
Age 63159 reports
Age 67156 reports
Age 65153 reports
Age 71152 reports
Age 73149 reports
Age 69142 reports
Age 77140 reports
Age 66139 reports
Age 80139 reports
Age 64130 reports
Age 53129 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ROMIPLOSTIM?

This profile reflects 24,148 FDA FAERS reports that mention ROMIPLOSTIM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROMIPLOSTIM?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PLATELET COUNT DECREASED, OFF LABEL USE, DEATH, THERAPEUTIC RESPONSE DECREASED, PLATELET COUNT ABNORMAL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROMIPLOSTIM?

Labeling and FAERS entries often list Amgen, Inc in connection with ROMIPLOSTIM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.