What the label lists and what reports show
Everolimus side effects
Everolimus's FDA label: “Most common adverse reactions (incidence ≥ 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite.” FAERS holds 49,208 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 (4,673 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the everolimus FDA label on DailyMed (effective June 1, 2026, Novartis Pharmaceuticals Corporation); 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 AFINITOR or AFINITOR DISPERZ?AFINITOR and AFINITOR DISPERZ can cause serious side effects, including: See “What is the most important information I should know about AFINITOR and AFINITOR DISPERZ?” for more information. Risk of wound healing problems. Wounds may not heal properly during AFINITOR and AFINITOR DISPERZ treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with AFINITOR and AFINITOR DISPERZ. You should stop taking AFINITOR and AFINITOR DISPERZ at least 1 week before planned surgery. Your healthcare provider should tell you when you may start taking AFINITOR and AFINITOR DISPERZ again after surgery. Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 1, 2026 (SPL set 2150f73a-179b-4afc-b8ce-67c85cc72f04), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite.
Table 7: Adverse Reactions Reported in ≥ 10% of Patients With Hormone Receptor-Positive Breast Cancer in BOLERO-2
| Reaction | All Grades % | Grade 3-4 % | All Grades % | Grade 3-4 % |
|---|---|---|---|---|
| Stomatitis a | 67 | 8 d | 11 | 0.8 |
| Diarrhea | 33 | 2 | 18 | 0.8 |
| Nausea | 29 | 0.4 | 28 | 1 |
| Vomiting | 17 | 1 | 12 | 0.8 |
| Constipation | 14 | 0.4 d | 13 | 0.4 |
| Dry mouth | 11 | 0 | 7 | 0 |
| Fatigue | 36 | 4 | 27 | 1 d |
| Edema peripheral | 19 | 1 d | 6 | 0.4 d |
| Pyrexia | 15 | 0.2 d | 7 | 0.4 d |
| Asthenia | 13 | 2 | 4 | 0 |
| Infections b | 50 | 6 | 25 | 2 d |
| Weight loss | 25 | 1 d | 6 | 0 |
| Decreased appetite | 30 | 1 d | 12 | 0.4 d |
| Hyperglycemia | 14 | 5 | 2 | 0.4 d |
| Arthralgia | 20 | 0.8 d | 17 | 0 |
| Back pain | 14 | 0.2 d | 10 | 0.8 d |
| Pain in extremity | 9 | 0.4 d | 11 | 2 d |
| Dysgeusia | 22 | 0.2 d | 6 | 0 |
| Headache | 21 | 0.4 d | 14 | 0 |
| Insomnia | 13 | 0.2 d | 8 | 0 |
| Cough | 24 | 0.6 d | 12 | 0 |
| Dyspnea | 21 | 4 | 11 | 1 |
| Epistaxis | 17 | 0 | 1 | 0 |
| Pneumonitis c | 19 | 4 | 0.4 | 0 |
| Rash | 39 | 1 d | 6 | 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 serious adverse reactions are described elsewhere in the labeling: Non-Infectious Pneumonitis [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Severe Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Angioedema with Concomitant Use of ACE inhibitors [see Warnings and Precautions (5.4)] Stomatitis [see Warnings and Precautions (5.5)] Renal Failure [see Warnings and Precautions (5.6)] Impaired Wound Healing [see Warnings and Precautions (5.7)] Metabolic Disorders [see Warnings and Precautions (5.9)] Myelosuppression [see Warnings and Precautions (5.10)] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.12)] Breast cancer, NET, RCC : Most common adverse reactions (incidence ≥ 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite. ( 6.1 ) TSC-Associated Renal Angiomyolipoma: Most common adverse reaction (incidence ≥ 30%) is stomatitis. ( 6.1 ) TSC-Associated SEGA : Most common adverse reactions (incidence ≥ 30%) are stomatitis and respiratory tract infection. ( 6.1 ) TSC-Associated Partial-Onset Seizures: Most common adverse reaction (incidence ≥ 30%) is stomatitis.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 1, 2026 (SPL set 2150f73a-179b-4afc-b8ce-67c85cc72f04), via openFDA; the full label on DailyMed
What do FAERS reports show?
49,208 reports list everolimus among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10,667 are coded as a death and 14,763 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, 16 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?
- Everolimus: 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