Ravulizumab side effects: what 13,413 FDA adverse event reports show
Brand names
Ultomiris
Who reports
13,413 reports · 56% serious · 941 with death outcome · 54% female
Used for
ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
What it is
Ravulizumab-cwvz, a complement inhibitor, is a humanized monoclonal antibody (mAb) produced in Chinese hamster ovary (CHO) cells. Ravulizumab-cwvz consists of 2 identical 448 amino acid heavy chains and 2 identical 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Boxed warning
SERIOUS MENINGOCOCCAL INFECTIONS ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 962 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Breakthrough haemolysis | 164 | 1,190.7 971.8–1,458.9ROR 1,205.4 · χ² 109,249 / p <1e-300 | 622.7 EB05 546.7 · IC025 +7.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=164 · 93% clinician | no trial data cached |
| Extravascular haemolysis | 139 | 778.0 634.9–953.4ROR 786.1 · χ² 71,135 / p <1e-300 | 482.6 EB05 418.9 · IC025 +7.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=139 | no trial data cached |
| Meningococcal infection | 38 | 213.5 152.1–299.6ROR 214.1 · χ² 6,872 / p <1e-300 | 171.5 EB05 130.5 · IC025 +5.2 3/3 methods agree | Labeled — boxed warning exact term | serious n=38 | no trial data cached |
| Meningococcal sepsis | 20 | 183.2 115.3–291.2ROR 183.5 · χ² 3,078 / p <1e-300 | 141.9 EB05 97.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Meningitis meningococcal | 17 | 176.8 107.1–292.0ROR 177.0 · χ² 2,510 / p <1e-300 | 135.0 EB05 89.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Paroxysmal nocturnal haemoglobinuria | 44 | 165.2 121.1–225.3ROR 165.7 · χ² 6,337 / p <1e-300 | 140.3 EB05 108.8 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=44 | no trial data cached |
| Myasthenia gravis crisis | 133 | 159.7 133.7–190.7ROR 161.3 · χ² 18,859 / p <1e-300 | 141.9 EB05 122.7 · IC025 +6.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=133 | no trial data cached |
| Neisseria infection | 11 | 146.0 78.7–270.8ROR 146.1 · χ² 1,317 / p 1e-288 | 108.8 EB05 64.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Myasthenia gravis | 474 | 100.0 91.2–109.5ROR 103.6 · χ² 43,534 / p <1e-300 | 93.6 EB05 86.7 · IC025 +6.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 99.4 | no trial data cached |
| Neuromyelitis optica spectrum disorder | 73 | 92.6 73.1–117.1ROR 93.1 · χ² 6,151 / p <1e-300 | 85.5 EB05 70.2 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=73 · ♀ 89% (drug 54%) | no trial data cached |
| Reticulocyte count increased | 43 | 87.3 64.2–118.7ROR 87.6 · χ² 3,391 / p <1e-300 | 79.8 EB05 61.8 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=38 | no trial data cached |
| Atypical haemolytic uraemic syndrome | 40 | 81.4 59.3–111.9ROR 81.7 · χ² 2,943 / p <1e-300 | 74.7 EB05 57.2 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=40 | no trial data cached |
| Haptoglobin decreased | 35 | 71.4 50.9–100.1ROR 71.5 · χ² 2,254 / p <1e-300 | 65.9 EB05 49.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Intravascular haemolysis | 24 | 70.2 46.7–105.7ROR 70.4 · χ² 1,501 / p <1e-300 | 63.9 EB05 45.2 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 | no trial data cached |
| Haemolysis | 325 | 68.4 61.3–76.4ROR 70.1 · χ² 20,614 / p <1e-300 | 65.3 EB05 59.6 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 72.4 | no trial data cached |
| Symptom recurrence | 243 | 67.4 59.4–76.6ROR 68.7 · χ² 15,176 / p <1e-300 | 64.3 EB05 57.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=48 | no trial data cached |
| Bulbar palsy | 10 | 59.0 31.4–110.9ROR 59.0 · χ² 494 / p 8e-110 | 51.6 EB05 29.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Dropped head syndrome | 13 | 53.9 31.0–93.7ROR 54.0 · χ² 602 / p 3e-133 | 48.7 EB05 30.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Mastication disorder | 82 | 43.1 34.6–53.6ROR 43.4 · χ² 3,240 / p <1e-300 | 41.6 EB05 34.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=38 · 90% consumer | no trial data cached |
| Eyelid ptosis | 272 | 42.9 38.0–48.3ROR 43.7 · χ² 10,786 / p <1e-300 | 41.6 EB05 37.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=98 · 83% consumer | no trial data cached |
| Vaccination site pain | 15 | 41.7 25.0–69.6ROR 41.7 · χ² 541 / p 6e-120 | 38.8 EB05 24.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Type iii immune complex mediated reaction | 13 | 37.3 21.5–64.7ROR 37.4 · χ² 414 / p 2e-92 | 34.8 EB05 21.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Suspected covid-19 | 66 | 31.5 24.7–40.2ROR 31.7 · χ² 1,882 / p <1e-300 | 30.7 EB05 24.9 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=39 | no trial data cached |
| Blood lactate dehydrogenase abnormal | 13 | 30.7 17.8–53.2ROR 30.8 · χ² 338 / p 8e-76 | 29.0 EB05 18.0 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Muscle discomfort | 12 | 24.6 13.9–43.6ROR 24.6 · χ² 245 / p 2e-55 | 23.3 EB05 14.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Immunisation reaction | 11 | 24.4 13.4–44.2ROR 24.4 · χ² 220 / p 4e-50 | 23.0 EB05 13.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Vein collapse | 11 | 22.9 12.6–41.5ROR 22.9 · χ² 206 / p 6e-47 | 21.5 EB05 12.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Haemoglobinuria | 16 | 22.6 13.8–36.9ROR 22.6 · χ² 304 / p 2e-68 | 21.7 EB05 14.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | no trial data cached |
| Diplopia (double vision) | 354 | 21.6 19.4–23.9ROR 22.1 · χ² 6,831 / p <1e-300 | 21.2 EB05 19.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 84% consumer | no trial data cached |
| Poor venous access | 136 | 20.8 17.6–24.6ROR 21.0 · χ² 2,514 / p <1e-300 | 20.5 EB05 17.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=67 · 80% consumer | no trial data cached |
| Exposure via body fluid | 10 | 19.9 10.7–37.2ROR 20.0 · χ² 159 / p 8e-37 | 18.5 EB05 9.8 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Muscle fatigue | 48 | 17.9 13.5–23.8ROR 18.0 · χ² 741 / p 2e-163 | 17.6 EB05 13.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 · ♀ 26% (drug 54%) · 81% consumer | no trial data cached |
| Sleep deficit | 23 | 17.6 11.7–26.5ROR 17.6 · χ² 339 / p 5e-76 | 17.0 EB05 11.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 · ♀ 30% (drug 54%) · 100% consumer | no trial data cached |
| Therapeutic response shortened | 338 | 16.7 15.1–18.6ROR 17.2 · χ² 4,942 / p <1e-300 | 16.6 EB05 15.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 19.0 | no trial data cached |
| Meningitis | 66 | 15.6 12.2–19.8ROR 15.6 · χ² 876 / p 8e-193 | 15.3 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious n=66 | no trial data cached |
| Iron overload | 10 | 14.6 7.8–27.2ROR 14.6 · χ² 112 / p 2e-26 | 12.7 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Renal transplant | 33 | 14.4 10.2–20.3ROR 14.4 · χ² 394 / p 5e-88 | 14.0 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Mean cell haemoglobin increased | 15 | 14.2 8.6–23.6ROR 14.2 · χ² 170 / p 4e-39 | 13.1 EB05 7.7 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Blood lactate dehydrogenase increased | 136 | 13.4 11.3–15.9ROR 13.5 · χ² 1,538 / p <1e-300 | 13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 11.1 | no trial data cached |
| Ophthalmoplegia | 13 | 13.0 7.5–22.4ROR 13.0 · χ² 131 / p 1e-30 | 11.5 EB05 6.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,777 | 3.6 3.4–3.7ROR 4.0 · χ² 3,414 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 88% consumer | no trial data cached |
| Asthenia (weakness) | 891 | 3.7 3.5–3.9ROR 3.9 · χ² 1,784 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.3 · 87% consumer | no trial data cached |
| Headache | 757 | 1.9 1.8–2.0ROR 1.9 · χ² 325 / p 7e-73 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.5 · 84% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 737 | 0.9 0.8–0.9ROR 0.9 · χ² 14 / p 8e-5 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Death | 590 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.051 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.1 | no trial data cached |
| Off label use (used outside approved label) | 561 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.423 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 517 | 1.4 1.3–1.6ROR 1.4 · χ² 67 / p 1e-16 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.2 · 78% consumer | no trial data cached |
| Muscular weakness | 508 | 7.0 6.4–7.6ROR 7.2 · χ² 2,611 / p <1e-300 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 86% consumer | no trial data cached |
| Myasthenia gravis | 474 | 100.0 91.2–109.5ROR 103.6 · χ² 43,534 / p <1e-300 | 93.6 EB05 86.7 · IC025 +6.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 99.4 | no trial data cached |
| Malaise (feeling unwell) | 467 | 1.7 1.5–1.8ROR 1.7 · χ² 124 / p 4e-29 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.5 · 82% consumer | no trial data cached |
| Pain | 432 | 1.1 1.0–1.2ROR 1.1 · χ² 4 / p 0.028 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 · 90% consumer | no trial data cached |
| Haemoglobin decreased | 409 | 6.2 5.7–6.8ROR 6.4 · χ² 1,790 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 | no trial data cached |
| Back pain | 383 | 2.6 2.3–2.8ROR 2.6 · χ² 371 / p 7e-83 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 · 81% consumer | no trial data cached |
| Feeling abnormal | 373 | 2.4 2.2–2.7ROR 2.5 · χ² 313 / p 2e-70 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 91% consumer | no trial data cached |
| Diplopia (double vision) | 354 | 21.6 19.4–23.9ROR 22.1 · χ² 6,831 / p <1e-300 | 21.2 EB05 19.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 84% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haptoglobin decreased — n=35, PRR 71.4
- Symptom recurrence — n=243, PRR 67.4
- Mastication disorder — n=82, PRR 43.1
- Eyelid ptosis — n=272, PRR 42.9
- Diplopia — n=354, PRR 21.6
- Poor venous access — n=136, PRR 20.8
- Sleep deficit — n=23, PRR 17.6
- Renal transplant — n=33, PRR 14.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ravulizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Ravulizumab are fatigue, asthenia, headache, dyspnoea, muscular weakness, myasthenia gravis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ravulizumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS MENINGOCOCCAL INFECTIONS ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors.
Do FAERS signals prove that Ravulizumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID a9a590d9-0217-43c7-908d-e62a71279791, effective 20251009; matched on
openfda.generic_name.exact:"RAVULIZUMAB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,002 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.