What the label lists and what reports show
Ramucirumab side effects
Ramucirumab's FDA label: “The most common adverse reactions observed in single agent CYRAMZA-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea.” FAERS holds 6,218 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is malignant neoplasm progression (810 reports).
- No generic listed
Check it at the source: the ramucirumab FDA label on DailyMed (effective June 9, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions observed in single agent CYRAMZA-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea.
Table 8: Adverse Reactions Occurring in ≥10% of Patients with a ≥2% Difference Between Arms in REACH-2
| Reaction | All Grades (%) | Grade ≥ 3 (%) | All Grades (%) | Grade ≥ 3 (%) |
|---|---|---|---|---|
| Fatigue a | 36 | 5 | 20 | 3 |
| Peripheral edema | 25 | 2 | 14 | 0 |
| Decreased appetite | 23 | 2 | 20 | 1 |
| Insomnia | 11 | 0 | 6 | 1 |
| Pyrexia | 10 | 0 | 3 | 0 |
| Hypertension a | 25 | 13 | 13 | 5 |
| Abdominal Pain a | 25 | 2 | 16 | 2 |
| Nausea | 19 | 0 | 12 | 0 |
| Ascites b | 18 | 4 | 7 | 1 |
| Vomiting | 10 | 0 | 7 | 0 |
| Proteinuria a , c | 20 | 2 | 4 | 0 |
| Headache | 14 | 0 | 5 | 1 |
| Epistaxis | 14 | <1 | 3 | 0 |
| Back Pain | 10 | <1 | 7 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )]. Gastrointestinal Perforations [see Warnings and Precautions ( 5.2 )]. Impaired Wound Healing [see Warnings and Precautions ( 5.3 )]. Arterial Thromboembolic Events [see Warnings and Precautions ( 5.4 )]. Hypertension [see Warnings and Precautions ( 5.5 )]. Infusion-Related Reactions [see Warnings and Precautions ( 5.6 )]. Worsening of Pre-existing Hepatic Impairment [see Warnings and Precautions ( 5.7 )]. Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.8 )]. Proteinuria Including Nephrotic Syndrome [see Warnings and Precautions ( 5.9 )]. Thyroid Dysfunction [see Warnings and Precautions ( 5.10 )]. The most common adverse reactions observed in single agent CYRAMZA-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. ( 6.1 ) The most common adverse reactions observed in patients treated with CYRAMZA with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis. …
Source: FDA drug label, Eli Lilly and Company, effective June 9, 2026 (SPL set c6080942-dee6-423e-b688-1272c2ae90d4), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,218 reports list ramucirumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,653 are coded as a death and 2,369 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ramucirumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions