Voydeya Side Effects: What to Expect and When to Call Your Doctor

Before starting Voydeya (danicopan), your doctor will review the risk profile of this medication with you as part of the VOYDEYA REMS program. Understanding what side effects to expect — and which ones require immediate medical attention — is important for your safety. This guide explains Voydeya's side effect profile in plain language.

The Black Box Warning: Serious Infection Risk

Voydeya carries the FDA's most serious warning level — a boxed warning — for the risk of serious and life-threatening infections caused by encapsulated bacteria. These include:

Neisseria meningitidis (bacterial meningitis)

Streptococcus pneumoniae (pneumococcal disease)

Haemophilus influenzae type B (Hib disease)

These infections can become rapidly life-threatening or fatal if not recognized and treated early. Even vaccinated patients remain at elevated risk. You will receive a Patient Safety Card from your prescriber — carry it at all times during treatment and for 1 week after your last dose.

Call 911 or Go to the ER Immediately If You Experience:

Sudden high fever or chills

Severe headache with stiff neck or back

Sensitivity to light (photophobia)

Nausea or vomiting with fever

Confusion or altered mental status

Body rash, especially one that spreads rapidly

Show your Patient Safety Card to any healthcare provider who treats you, so they know to evaluate you for serious encapsulated bacterial infections.

Most Common Side Effect: Headache

The most frequently reported side effect of Voydeya in clinical trials was headache, occurring in at least 10% of patients treated with danicopan in the ALPHA trial. For most patients, headache is mild to moderate and manageable with over-the-counter pain relievers. If your headache is severe, comes on suddenly, or is accompanied by fever or stiff neck, seek medical attention immediately (see infection warning above).

Other Common Side Effects (Reported in ≥5% of Patients)

Vomiting — nausea and vomiting were reported more frequently in Voydeya-treated patients than placebo

Pyrexia (fever) — a fever while on Voydeya always warrants evaluation to rule out serious infection

Elevated liver enzymes (ALT increase) — hepatic enzyme elevations are clinically relevant with Voydeya; baseline and periodic liver function tests are required

Hypertension (high blood pressure) — blood pressure monitoring may be appropriate during treatment

Pain in extremities — limb pain was reported in ≥5% of patients

Increased triglycerides — hyperlipidemia is a clinically relevant adverse effect; baseline lipid panel and monitoring required

Serious Adverse Reactions (Less Common but Important)

In the ALPHA trial, serious adverse reactions were reported in 5% of Voydeya-treated patients. These included:

Pancreatitis (inflammation of the pancreas)

Cholecystitis (gallbladder inflammation)

Significantly increased blood bilirubin (jaundice risk)

Hepatic enzyme elevations leading to discontinuation in some patients

Liver Health: What Monitoring Is Required?

Voydeya can increase liver enzymes. Your doctor will check your liver function tests (LFTs) before you start treatment and monitor them periodically while you are on Voydeya. Voydeya is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C). Call your doctor right away if you notice yellowing of your skin or eyes (jaundice), dark urine, upper-right abdominal pain, or extreme fatigue — these can be signs of liver problems.

What If I Need to Stop Taking Voydeya?

Never stop Voydeya without talking to your doctor. Stopping complement inhibition — whether Voydeya or your C5 inhibitor — can cause a dangerous rebound in hemolysis. If you need to discontinue Voydeya due to a side effect, your hematologist will create a medically supervised plan to do so safely.

For more information on Voydeya safety, see our article on Voydeya drug interactions. If you need help finding where to fill your Voydeya prescription, medfinder can help you navigate specialty pharmacy access.