What the label lists and what reports show
Bevacizumab-maly side effects
Bevacizumab-maly's FDA label: “Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.” FAERS holds 191 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 asthenia (14 reports).
- No generic listed
Check it at the source: the bevacizumab-maly FDA label on DailyMed (effective January 27, 2026, Valorum Biologics, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.
Table 4: Grades 1 - 4 Adverse Reactions Occurring at Higher Incidence (≥ 5%) in Patients…
| Adverse Reaction a | Bevacizumab with Chemotherapy (N=218) | Chemotherapy (N=222) |
|---|---|---|
| Fatigue | 80% | 75% |
| Peripheral edema | 15% | 22% |
| Decreased appetite | 34% | 26% |
| Hyperglycemia | 26% | 19% |
| Hypomagnesemia | 24% | 15% |
| Weight loss | 21% | 7% |
| Hyponatremia | 19% | 10% |
| Hypoalbuminemia | 16% | 11% |
| Hypertension | 29% | 6% |
| Thrombosis | 10% | 3% |
| Urinary tract infection | 22% | 14% |
| Infection | 10% | 5% |
| Headache | 22% | 13% |
| Dysarthria | 8% | 1% |
| Anxiety | 17% | 10% |
| Epistaxis | 17% | 1% |
| Increased blood creatinine | 16% | 10% |
| Proteinuria | 10% | 3% |
| Stomatitis | 15% | 10% |
| Proctalgia | 6% | 1% |
| Anal fistula | 6% | 0% |
| Pelvic pain | 14% | 8% |
| Neutropenia | 12% | 6% |
| Lymphopenia | 12% | 5% |
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 clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. Surgery and Wound Healing Complications [see Warnings and Precautions (5.2)]. Hemorrhage [see Warnings and Precautions (5.3)]. Arterial Thromboembolic Events [see Warnings and Precautions (5.4)]. Venous Thromboembolic Events [see Warnings and Precautions (5.5)]. Hypertension [see Warnings and Precautions (5.6)]. Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.7)]. Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. Infusion-Related Reactions [see Warnings and Precautions (5.9)]. Ovarian Failure [see Warnings and Precautions (5.11)]. Congestive Heart Failure [see Warnings and Precautions (5.12)]. Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Valorum Biologics, LLC at 1-844-576-2709 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, BLA761231 (Amneal Pharms Llc), as published by Valorum Biologics, LLC, effective January 27, 2026 (SPL set 42b4f96e-1f70-2126-e063-6294a90a93e3), via openFDA; the full label on DailyMed
What do FAERS reports show?
191 reports list bevacizumab-maly among the medicines taken, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 53 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 20 reactions below, 8 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.
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?
- Bevacizumab-maly: 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