What the label lists and what reports show
Vandetanib side effects
Vandetanib's FDA label: “The most common adverse drug reactions (>20%) seen with CAPRELSA and with a between-arm difference of ≥5 % have been diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infections, decreased appetite and …” FAERS holds 1,794 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 (329 reports).
- No generic listed
- Boxed warning
Check it at the source: the vandetanib FDA label on DailyMed (effective April 23, 2026, Genzyme 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 CAPRELSA?CAPRELSA may cause serious side effects, including: See " What is the most important information I should know about CAPRELSA? " Severe skin reactions. CAPRELSA can cause severe skin reactions that can lead to death, such as toxic epidermal necrolysis and Stevens-Johnson syndrome, or other serious skin reactions that may affect any part of your body. These severe skin reactions may be life threatening and you may need to be treated in a hospital. Tell your healthcare provider right away if you get any of these symptoms: skin rash or acne dry skin itching blisters on your skin redness or swelling of your face, hands, or soles of your feet blisters or sores in your mouth peeling of your skin fever muscle or joint aches Breathing problems (interstitial lung disease). CAPRELSA may cause a breathing problem called interstitial lung disease that can lead to death. […]
Source: FDA drug label, Genzyme Corporation, effective April 23, 2026 (SPL set e5721cb8-4185-47b9-bbb3-1c587e558a03), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse drug reactions (>20%) seen with CAPRELSA and with a between-arm difference of ≥5 % have been diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infections, decreased appetite and abdominal pain.
Table 1: Per-Patient Incidence of Selected Adverse Reactions Occurring at a Higher Incidence in CAPRELSA-Treated Patients During Randomized Treatment (Between-Arm Difference of ≥5% [All Grades] CTCAE version 3 was used…
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Diarrhea/Colitis | 57 | 11 | 27 | 2 |
| Nausea | 33 | 1 | 16 | 0 |
| Abdominal Pain Includes abdominal pain, abdominal pain upper, lower abdominal pain, and… | 21 | 3 | 11 | 0 |
| Vomiting | 15 | 1 | 7 | 0 |
| Dyspepsia | 11 | 0 | 4 | 0 |
| Dry Mouth | 9 | 0 | 3 | 0 |
| Rash Includes rash, rash (erythematous, generalized, macular, maculopapular, papular,… | 53 | 5 | 12 | 0 |
| Dermatitis Acneiform/Acne | 35 | 1 | 7 | 0 |
| Dry Skin | 15 | 0 | 5 | 0 |
| Photosensitivity Reaction | 13 | 2 | 0 | 0 |
| Pruritus | 11 | 1 | 4 | 0 |
| Nail abnormalities Includes nail disorder, nail bed inflammation, nail bed tenderness,… | 9 | 0 | 0 | 0 |
| Alopecia | 8 | N/A | 0 | N/A |
| Hypertension/Hypertensive Crisis/Accelerated Hypertension | 33 | 9 | 5 | 1 |
| Headache | 26 | 1 | 9 | 0 |
| Dysgeusia | 8 | 0 | 3 | 0 |
| Fatigue Included in Table 1 due to the increased incidence of severe fatigue in the… | 24 | 6 | 23 | 1 |
| Upper Respiratory Tract Infections Includes laryngitis, nasopharyngitis, pharyngitis,… | 23 | 0 | 16 | 0 |
| Decreased Appetite | 21 | 4 | 12 | 0 |
| Hypocalcemia | 11 | 2 | 3 | 0 |
| ECG QT Prolonged 69% had QT prolongation >450 ms and 7% had QT prolongation >500 ms by… | 14 | 8 | 1 | 1 |
| Corneal Abnormalities Includes corneal edema, corneal opacity, corneal dystrophy, corneal… | 13 | 0 | 1 | 0 |
| Blurred Vision | 9 | 0 | 1 | 0 |
| Proteinuria | 10 | 0 | 2 | 0 |
| Depression | 10 | 2 | 3 | 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 discussed elsewhere in the label: QT Prolongation and Torsades de Pointes [see Boxed Warning, Warnings and Precautions (5.1) ] Severe Skin Reactions [see Warnings and Precautions (5.2) ] Interstitial Lung Disease [see Warnings and Precautions (5.3) ] Ischemic Cerebrovascular Events [see Warnings and Precautions (5.4) ] Hemorrhage [see Warnings and Precautions (5.5) ] Heart Failure [see Warnings and Precautions (5.6) ] Diarrhea [see Warnings and Precautions (5.7) ] Hypothyroidism [see Warnings and Precautions (5.8) ] Hypertension [see Warnings and Precautions (5.9) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.10) ] Renal Failure [see Warnings and Precautions (5.12) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.15) ] Osteonecrosis [see Warnings and Precautions (5.16) ] The most common adverse drug reactions (>20%) seen with CAPRELSA and with a between-arm difference of ≥5 % have been diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infections, decreased appetite and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, Contact Sanofi Genzyme at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Genzyme Corporation, effective April 23, 2026 (SPL set e5721cb8-4185-47b9-bbb3-1c587e558a03), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,794 reports list vandetanib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 161 are coded as a death and 522 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, 12 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?
- Vandetanib: 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