What the label lists and what reports show
Axitinib side effects
Axitinib's FDA label: “Most common adverse reactions (≥20%) are: INLYTA in combination with avelumab: diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity …” FAERS holds 19,366 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 diarrhoea (2,578 reports).
- No generic listed
Check it at the source: the axitinib FDA label on DailyMed (effective March 12, 2026, U.S. Pharmaceuticals); 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 INLYTA?INLYTA may cause serious side effects, including: • High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA. • Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms: o chest pain or pressure o pain in your arms, back, neck or jaw o shortness of breath o numbness or weakness on one side of your body o trouble talking o headache o vision changes • Bleeding. […]
Source: FDA drug label, NDA202324 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective March 12, 2026 (SPL set 8a903e31-936e-4ed7-8a59-59f32374f338), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥20%) are: INLYTA in combination with avelumab: diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.
Table 8: Adverse Reactions Occurring in ≥10% of Patients Who Received INLYTA or Sorafenib
| Reaction | All Grades National Cancer Institute Common Terminology Criteria for Adverse Events,… % | Grade 3/4 % | All Grades % | Grade 3/4 % |
|---|---|---|---|---|
| Diarrhea | 55 | 11 | 53 | 7 |
| Hypertension | 40 | 16 | 29 | 11 |
| Fatigue | 39 | 11 | 32 | 5 |
| Decreased appetite | 34 | 5 | 29 | 4 |
| Nausea | 32 | 3 | 22 | 1 |
| Dysphonia | 31 | 0 | 14 | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 27 | 5 | 51 | 16 |
| Weight decreased | 25 | 2 | 21 | 1 |
| Vomiting | 24 | 3 | 17 | 1 |
| Asthenia | 21 | 5 | 14 | 3 |
| Constipation | 20 | 1 | 20 | 1 |
| Hypothyroidism | 19 | <1 | 8 | 0 |
| Cough | 15 | 1 | 17 | 1 |
| Mucosal inflammation | 15 | 1 | 12 | 1 |
| Arthralgia | 15 | 2 | 11 | 1 |
| Stomatitis | 15 | 1 | 12 | <1 |
| Dyspnea | 15 | 3 | 12 | 3 |
| Abdominal pain | 14 | 2 | 11 | 1 |
| Headache | 14 | 1 | 11 | 0 |
| Pain in extremity | 13 | 1 | 14 | 1 |
| Rash | 13 | <1 | 32 | 4 |
| Proteinuria | 11 | 3 | 7 | 2 |
| Dysgeusia | 11 | 0 | 8 | 0 |
| Dry skin | 10 | 0 | 11 | 0 |
| Dyspepsia | 10 | 0 | 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, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling [see Warnings and Precautions (5) ]: • Hypertension [see Warnings and Precautions (5.1) ] • Arterial thromboembolic events [see Warnings and Precautions (5.2) ] • Venous thromboembolic events [see Warnings and Precautions (5.3) ] • Hemorrhage [see Warnings and Precautions (5.4) ] • Cardiac failure [see Warnings and Precautions (5.5) ] • Gastrointestinal perforation and fistula formation [see Warnings and Precautions (5.6) ] • Thyroid dysfunction [see Warnings and Precautions (5.7) ] • Reversible posterior leukoencephalopathy syndrome [see Warnings and Precautions (5.9) ] • Proteinuria [see Warnings and Precautions (5.10) ] • Hepatotoxicity [see Warnings and Precautions (5.11) ] • Hepatic impairment [see Warnings and Precautions (5.12) ] Most common adverse reactions (≥20%) are: INLYTA in combination with avelumab: diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. …
Source: FDA drug label, NDA202324 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective March 12, 2026 (SPL set 8a903e31-936e-4ed7-8a59-59f32374f338), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,366 reports list axitinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,908 are coded as a death and 4,996 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 22 reactions below, 19 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?
- Axitinib: 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