What the label lists and what reports show
Crizanlizumab side effects
Crizanlizumab's FDA label: “The most common adverse reactions (incidence ≥ 10%) were headache, arthralgia, nausea, back pain, fatigue, abdominal pain, pyrexia, diarrhea, vomiting, and oropharyngeal pain.” FAERS holds 1,389 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 sickle cell anaemia with crisis (360 reports).
- No generic listed
Check it at the source: the crizanlizumab FDA label on DailyMed (effective June 4, 2026); 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 ADAKVEO?ADAKVEO may cause serious side effects. See "What is the most important information I should know about ADAKVEO?" The most common side effects of ADAKVEO include: headache joint pain nausea back pain fatigue stomach pain fever diarrhea vomiting throat pain These are not all of the possible side effects of ADAKVEO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 4, 2026 (SPL set b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥ 10%) were headache, arthralgia, nausea, back pain, fatigue, abdominal pain, pyrexia, diarrhea, vomiting, and oropharyngeal pain.
Table 1: Adverse Reactions (≥ 10%) in Patients Receiving ADAKVEO With a Difference Between Arms of > 3% Compared to Placebo in SUSTAIN
| Adverse Reactions | All Grades % | Grade ≥ 3 % | All Grades % | Grade ≥ 3 % |
|---|---|---|---|---|
| Arthralgia | 18 | 2 | 8 | 2 |
| Nausea | 18 | 0 | 11 | 2 |
| Back pain | 15 | 0 | 11 | 0 |
| Abdominal pain a | 12 | 0 | 5 | 0 |
| Pyrexia | 11 | 12 | 7 | 0 |
| Diarrhea | 11 | 0 | 3 | 2 |
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: Infusion-related reactions [see Warnings and Precautions (5.1)] The most common adverse reactions (incidence ≥ 10%) were headache, arthralgia, nausea, back pain, fatigue, abdominal pain, pyrexia, diarrhea, vomiting, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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. Sickle Cell Disease SUSTAIN Trial The safety of ADAKVEO was evaluated in the SUSTAIN trial [see Clinical Studies (14.1)]. Eligible patients were diagnosed with sickle cell disease (any genotype, including HbSS, HbSC, HbS beta 0 -thalassemia, HbS beta + -thalassemia, and others). Patients received ADAKVEO 5 mg/kg (N = 66) or 2.5 mg/kg (N = 64) or placebo (N = 62) administered by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter. The safety evaluation below is limited to the patients who received the recommended dose of 5 mg/kg. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 4, 2026 (SPL set b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,389 reports list crizanlizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 55 are coded as a death and 570 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, 14 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?
- Crizanlizumab: 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