Drug · FAERS side-effect profile with label screen
Ramucirumab side effects: what 6,217 FDA adverse event reports show
Drug class
Vascular Endothelial Growth Factor Receptor 2 Antagonist
FDA label (Established Pharmacologic Class)
Brand names
Cyramza
openFDA label
Who reports
6,217 reports · 94% serious · 1,653 with death outcome · 34% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CYRAMZA ® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
FDA label, Indications and Usage
What it is
Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147 kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells.
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 14Labeled (related wording) 4Reporting / coding artifact 3Not in label — unassessed 19
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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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. 111 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 810 | 27.0 25.3–28.8ROR 30.9 · χ² 20,209 / p <1e-300 | 26.8 EB05 25.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 | no trial data cached |
| Proteinuria | 140 | 25.2 21.4–29.7ROR 25.8 · χ² 3,211 / p <1e-300 | 25.0 EB05 21.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 | no trial data cached |
| Interstitial lung disease | 299 | 21.0 18.8–23.5ROR 22.0 · χ² 5,651 / p <1e-300 | 20.8 EB05 18.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 | no trial data cached |
| Ascites | 176 | 20.3 17.5–23.5ROR 20.9 · χ² 3,194 / p <1e-300 | 20.1 EB05 17.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 | no trial data cached |
| Disseminated intravascular coagulation | 70 | 16.8 13.3–21.2ROR 17.0 · χ² 1,020 / p 5e-224 | 16.6 EB05 13.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Peritonitis | 93 | 15.2 12.4–18.6ROR 15.4 · χ² 1,216 / p 1e-266 | 15.1 EB05 12.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Neutrophil count decreased | 179 | 15.0 12.9–17.3ROR 15.4 · χ² 2,312 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Febrile neutropenia | 262 | 13.4 11.9–15.1ROR 13.9 · χ² 2,989 / p <1e-300 | 13.3 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Pneumonitis | 99 | 12.4 10.2–15.1ROR 12.6 · χ² 1,023 / p 1e-224 | 12.2 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Therapy partial responder | 55 | 12.4 9.5–16.1ROR 12.5 · χ² 561 / p 2e-124 | 12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 | no trial data cached |
| Thrombotic microangiopathy | 35 | 12.2 8.8–17.0ROR 12.3 · χ² 348 / p 5e-78 | 11.8 EB05 8.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Polyneuropathy | 39 | 11.1 8.1–15.2ROR 11.2 · χ² 347 / p 1e-77 | 10.6 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Metastases to liver | 51 | 9.8 7.5–12.9ROR 9.9 · χ² 395 / p 3e-88 | 9.4 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 90% clinician | no trial data cached |
| Haemoptysis | 77 | 9.3 7.5–11.6ROR 9.4 · χ² 562 / p 1e-124 | 9.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Haematotoxicity | 25 | 9.1 6.2–13.5ROR 9.1 · χ² 172 / p 1e-39 | 8.3 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 96% clinician | no trial data cached |
| Hepatic encephalopathy | 25 | 9.0 6.1–13.4ROR 9.1 · χ² 171 / p 3e-39 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Intestinal perforation | 30 | 9.0 6.3–12.9ROR 9.1 · χ² 206 / p 6e-47 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Pneumothorax | 42 | 9.0 6.6–12.1ROR 9.0 · χ² 288 / p 6e-65 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Metastases to lung | 28 | 8.2 5.7–11.9ROR 8.2 · χ² 169 / p 5e-39 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 100% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 22 | 7.8 5.1–11.9ROR 7.8 · χ² 124 / p 5e-29 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Ileus | 28 | 7.7 5.3–11.1ROR 7.7 · χ² 156 / p 4e-36 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Myelosuppression | 77 | 7.6 6.1–9.6ROR 7.7 · χ² 438 / p 1e-97 | 7.4 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Mucosal inflammation | 58 | 7.5 5.8–9.7ROR 7.6 · χ² 321 / p 4e-72 | 7.2 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 263 | 6.6 5.8–7.4ROR 6.8 · χ² 1,239 / p 1e-271 | 6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Gastric haemorrhage | 22 | 6.4 4.2–9.7ROR 6.4 · χ² 95 / p 9e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 44 | 6.4 4.7–8.5ROR 6.4 · χ² 193 / p 3e-44 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 173 | 6.2 5.3–7.2ROR 6.3 · χ² 748 / p 5e-165 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Generalised oedema | 21 | 5.8 3.8–8.8ROR 5.8 · χ² 78 / p 6e-19 | 5.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Disease progression | 199 | 5.7 5.0–6.5ROR 5.9 · χ² 769 / p 1e-169 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 96% clinician | no trial data cached |
| Metastases to central nervous system | 21 | 5.5 3.6–8.5ROR 5.6 · χ² 73 / p 5e-18 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 · 95% clinician | no trial data cached |
| Fistula | 18 | 5.4 3.4–8.6ROR 5.4 · χ² 60 / p 5e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Subarachnoid haemorrhage | 16 | 5.3 3.2–8.6ROR 5.3 · χ² 51 / p 4e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Stomatitis (mouth sores) | 95 | 5.3 4.3–6.5ROR 5.4 · χ² 326 / p 3e-73 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Bone marrow failure | 32 | 5.3 3.7–7.5ROR 5.3 · χ² 107 / p 3e-25 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Neurotoxicity | 27 | 5.2 3.6–7.6ROR 5.3 · χ² 89 / p 2e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Hyperbilirubinaemia | 16 | 5.2 3.2–8.6ROR 5.3 · χ² 51 / p 5e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Cholecystitis | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 55 / p 5e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Adrenal insufficiency | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 55 / p 6e-14 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Pleural effusion | 91 | 5.0 4.1–6.2ROR 5.1 · χ² 291 / p 1e-65 | 4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Septic shock | 63 | 4.9 3.8–6.3ROR 5.0 · χ² 193 / p 3e-44 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 810 | 27.0 25.3–28.8ROR 30.9 · χ² 20,209 / p <1e-300 | 26.8 EB05 25.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 | no trial data cached |
| Death | 589 | 2.3 2.1–2.5ROR 2.4 · χ² 453 / p 7e-101 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.4 | no trial data cached |
| Interstitial lung disease | 299 | 21.0 18.8–23.5ROR 22.0 · χ² 5,651 / p <1e-300 | 20.8 EB05 18.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 263 | 6.6 5.8–7.4ROR 6.8 · χ² 1,239 / p 1e-271 | 6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Febrile neutropenia | 262 | 13.4 11.9–15.1ROR 13.9 · χ² 2,989 / p <1e-300 | 13.3 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Decreased appetite (loss of appetite) | 231 | 3.4 3.0–3.8ROR 3.5 · χ² 386 / p 4e-86 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Disease progression | 199 | 5.7 5.0–6.5ROR 5.9 · χ² 769 / p 1e-169 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 96% clinician | no trial data cached |
| Hypertension (high blood pressure) | 192 | 3.1 2.7–3.5ROR 3.1 · χ² 266 / p 4e-60 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Neutrophil count decreased | 179 | 15.0 12.9–17.3ROR 15.4 · χ² 2,312 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Ascites | 176 | 20.3 17.5–23.5ROR 20.9 · χ² 3,194 / p <1e-300 | 20.1 EB05 17.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 173 | 6.2 5.3–7.2ROR 6.3 · χ² 748 / p 5e-165 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Anaemia (low red blood cells) | 159 | 2.8 2.4–3.3ROR 2.9 · χ² 185 / p 2e-42 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Proteinuria | 140 | 25.2 21.4–29.7ROR 25.8 · χ² 3,211 / p <1e-300 | 25.0 EB05 21.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 | no trial data cached |
| Platelet count decreased | 116 | 3.7 3.1–4.4ROR 3.7 · χ² 224 / p 6e-51 | 3.6 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Thrombocytopenia (low platelets) | 106 | 3.2 2.7–3.9ROR 3.2 · χ² 160 / p 7e-37 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | 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.
- Disseminated intravascular coagulation — n=70, PRR 16.8
- Peritonitis — n=93, PRR 15.2
- Pneumonitis — n=99, PRR 12.4
- Polyneuropathy — n=39, PRR 11.1
- Haematotoxicity — n=25, PRR 9.1
- Ileus — n=28, PRR 7.7
- Myelosuppression — n=77, PRR 7.6
- Palmar-plantar erythrodysaesthesia syndrome — n=44, PRR 6.4
- Neuropathy peripheral — n=173, PRR 6.2
- Generalised oedema — n=21, PRR 5.8
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 Ramucirumab?
In FDA FAERS, the most frequently co-reported reaction terms for Ramucirumab are interstitial lung disease, neutropenia, febrile neutropenia, decreased appetite, hypertension, neutrophil count decreased. 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 Ramucirumab have an FDA boxed warning?
No. The FDA label retrieved for Ramucirumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ramucirumab 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 c6080942-dee6-423e-b688-1272c2ae90d4, effective 20260609; matched on
openfda.generic_name.exact:"RAMUCIRUMAB") - 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, 151 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.