What the label lists and what reports show
Danicopan side effects
Danicopan's FDA label: “Among the 57 patients treated with VOYDEYA in Study ALXN2040-PNH-301, the most common adverse reaction (≥10%) was headache.” FAERS holds 273 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 haemoglobin decreased (34 reports).
- No generic listed
- Boxed warning
Check it at the source: the danicopan FDA label on DailyMed (effective May 12, 2026, Alexion Pharmaceuticals 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 VOYDEYA?VOYDEYA may cause side effects, including: See " What is the most important information I should know about VOYDEYA? " Increased liver enzyme levels. Your healthcare provider will do blood tests to check your liver enzyme levels before and during treatment with VOYDEYA. Your healthcare provider may temporarily or permanently stop treatment with VOYDEYA if you develop increased liver enzyme levels. Increased cholesterol. VOYDEYA may increase your cholesterol. Your healthcare provider will do blood tests to check your cholesterol during treatment with VOYDEYA. The most common side effect of VOYDEYA is headache. Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of VOYDEYA. 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, Alexion Pharmaceuticals Inc., effective May 12, 2026 (SPL set ab8d1cbd-a28b-4d49-82ab-5c7460719ac7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsAmong the 57 patients treated with VOYDEYA in Study ALXN2040-PNH-301, the most common adverse reaction (≥10%) was headache.
Table 1 Adverse Reactions Reported in ≥5% of VOYDEYA-Treated Patients with PNH and Greater than Placebo
| Reaction | VOYDEYA (with ravulizumab or eculizumab) N = 57 n (%) | Placebo (ravulizumab or eculizumab only) N = 29 n (%) |
|---|---|---|
| Headache | 6 (11) | 3 (10) |
| Vomiting Represents a composite of multiple, related adverse reactions | 4 (7) | 0 (0) |
| Pyrexia | 4 (7) | 0 (0) |
| Alanine aminotransferase increased | 3 (5) | 1 (3) |
| Hypertension | 3 (5) | 1 (3) |
| Pain in extremity | 3 (5) | 0 (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 in greater detail in other sections of the labeling: Serious Infections Caused by Encapsulated Bacteria [see Warnings and Precautions (5.1) ] Hepatic Enzyme Increases [see Warnings and Precautions (5.3) ] Hyperlipidemia [see Warnings and Precautions (5.4) ] Most frequent adverse reaction (incidence ≥10%) was headache ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 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. The safety of VOYDEYA was evaluated in 86 adults with PNH in Study ALXN2040-PNH-301 [see Clinical Studies (14) ]. Study ALXN2040-PNH-301 enrolled adults with PNH with clinically significant EVH who had been treated with a stable dose of ravulizumab or eculizumab for at least the previous 6 months. Patients were randomly assigned 2:1 to receive double-blind VOYDEYA 150 mg (n=57) or placebo (n=29) orally three times a day in addition to ravulizumab or eculizumab for 12 weeks. …
Source: FDA drug label, Alexion Pharmaceuticals Inc., effective May 12, 2026 (SPL set ab8d1cbd-a28b-4d49-82ab-5c7460719ac7), via openFDA; the full label on DailyMed
What do FAERS reports show?
273 reports list danicopan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 75 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, 6 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.
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?
- Danicopan: 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