What the label lists and what reports show
Fruquintinib side effects
Fruquintinib's FDA label: “Most common adverse reactions (incidence ≥20%) are hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.” FAERS holds 3,770 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 fatigue (470 reports).
- No generic listed
Check it at the source: the fruquintinib FDA label on DailyMed (effective July 31, 2026, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FRUZAQLA?FRUZAQLA may cause serious side effects, including: High blood pressure (hypertension). High blood pressure is common with FRUZAQLA and can also be severe. Your healthcare provider will check your blood pressure before starting treatment with FRUZAQLA, 1 time every week for the first month of treatment, and then at least 1 time a month or more often if needed during treatment. Your healthcare provider may prescribe medicine to treat your high blood pressure if needed. Tell your healthcare provider if you get any of the following symptoms of hypertension during treatment: severe headache lightheadedness or dizziness confusion changes in vision chest pain trouble breathing nosebleeds vomiting Severe bleeding (hemorrhage). FRUZAQLA can cause bleeding that can be serious and may lead to death. […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective July 31, 2026 (SPL set 186d786e-dc8a-45f2-b5e1-01ac0201879f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥20%) are hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
Table 5: Adverse Reactions (≥10%) in Patients who Received FRUZAQLA and with a Difference Between Arms of ≥5% Compared to Placebo in FRESCO (All Grades)
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Hypertension Represents a composite of multiple related terms. | 61 | 23 | 17 | 2.2 |
| Hemorrhage | 28 | 1.1 | 14 | 0 |
| Proteinuria | 55 | 4.7 | 30 | 0 |
| Palmar-plantar erythrodysesthesia (hand-foot skin reactions) | 49 | 11 | 2.9 | 0 |
| Dysphonia | 38 | 0 | 1.5 | 0 |
| Throat Pain | 10 | 0 | 1.5 | 0 |
| Stomatitis | 33 | 0.7 | 2.9 | 0 |
| Abdominal Pain | 29 | 4 | 17 | 1.5 |
| Diarrhea | 25 | 3.6 | 5 | 0 |
| Fatigue | 25 | 2.5 | 13 | 1.5 |
| Anorexia | 21 | 1.4 | 9 | 0 |
| Musculoskeletal Pain | 22 | 2.2 | 6 | 1.5 |
| Back Pain | 15 | 1.8 | 7 | 0 |
| Arthralgia | 13 | 0.4 | 2.2 | 0 |
| Hypothyroidism | 17 | 0 | 2.2 | 0 |
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, continuedADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypertension [see Warnings and Precautions (5.1) ]. Hemorrhagic Events [see Warnings and Precautions (5.2) ]. Infections [see Warnings and Precautions (5.3) ]. Gastrointestinal Perforation [see Warnings and Precautions (5.4) ]. Hepatotoxicity [see Warnings and Precautions (5.5) ]. Proteinuria [see Warnings and Precautions (5.6) ]. Palmar-Plantar Erythrodysesthesia (PPE) [see Warnings and Precautions (5.7) ]. Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.8) ]. Most common adverse reactions (incidence ≥20%) are hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-844-662-8532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective July 31, 2026 (SPL set 186d786e-dc8a-45f2-b5e1-01ac0201879f), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,770 reports list fruquintinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,245 are coded as a death and 1,141 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. Reports rose sharply in 2025 (1,820, against a median of 6 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 10 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?
- Fruquintinib: 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