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Ranibizumab side effects: what 26,388 FDA adverse event reports show

Ranibizumab · Susvimo · 1,044 reaction terms · 64,361 drug–reaction co-reports · data 2026-09-14
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Drug class

Vascular Endothelial Growth Factor Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Susvimo

openFDA label

Who reports

26,388 reports · 85% serious · 5,093 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.1 ). Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.2 ).

FDA label, Indications and Usage

What it is

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor-A (VEGF-A).

FDA label, Description section

Boxed warning

ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions.

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 4Labeled (related wording) 6Likely indication confounding 12Reporting / coding artifact 1Not in label — unassessed 17
What the badges mean

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. 1,004 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Conjunctival retraction112,153.4
685.7–6,762.4ROR 2,154.3 · χ² 5,749 / p <1e-300
287.6 EB05 171.4 · IC025 +3.4
3/3 methods agree
Labeled — boxed warning
exact term
serious n=8not reported in cached trials
Polypoidal choroidal vasculopathy1991,442.8
1,141.9–1,823.1ROR 1,453.8 · χ² 100,363 / p <1e-300
484.4 EB05 430.5 · IC025 +7.6
3/3 methods agree
Not in label — unassessedserious n=198 · ♀ 28% (drug 56%) · 97% cliniciannot reported in cached trials
Foveal reflex abnormal111,435.6
531.0–3,881.6ROR 1,436.2 · χ² 5,070 / p <1e-300
269.8 EB05 160.7 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Retinal pigment epithelial tear321716.1
615.8–832.8ROR 724.9 · χ² 119,364 / p <1e-300
366.3 EB05 333.9 · IC025 +7.7
3/3 methods agree
Not in label — unassessedserious n=321NCT00637377: 1/291 (0.3%) on Ranibizumab (serious AE)
Diabetic retinal oedema229654.4
549.3–779.7ROR 660.2 · χ² 81,035 / p <1e-300
346.6 EB05 310.5 · IC025 +7.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=226not reported in cached trials
Conjunctival bleb24648.0
377.4–1,112.9ROR 648.6 · χ² 8,133 / p <1e-300
276.8 EB05 195.8 · IC025 +4.7
3/3 methods agree
Labeled — boxed warning
exact term
serious n=16 · 100% cliniciannot reported in cached trials
Choroidal neovascularisation358585.2
510.6–670.8ROR 593.3 · χ² 119,164 / p <1e-300
329.4 EB05 301.8 · IC025 +7.7
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=351NCT00637377: 1/291 (0.3%) on Ranibizumab (serious AE)
Subretinal fibrosis81566.3
425.6–753.5ROR 568.1 · χ² 26,199 / p <1e-300
305.3 EB05 253.5 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious n=77not reported in cached trials
Macular scar73492.8
367.8–660.3ROR 494.1 · χ² 21,688 / p <1e-300
280.6 EB05 230.6 · IC025 +6.2
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=70NCT00637377: 1/309 (0.3%) on Ranibizumab (serious AE)
Retinal scar154398.0
327.9–483.0ROR 400.3 · χ² 40,170 / p <1e-300
255.8 EB05 223.7 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious n=153not reported in cached trials
Subretinal fluid336372.7
327.5–424.1ROR 377.5 · χ² 84,138 / p <1e-300
249.2 EB05 227.7 · IC025 +7.3
3/3 methods agree
Not in label — unassessedserious n=327 · 92% cliniciannot reported in cached trials
Age-related macular degeneration445327.8
293.7–365.9ROR 333.4 · χ² 101,978 / p <1e-300
229.1 EB05 211.8 · IC025 +7.4
3/3 methods agree
Likely indication confounding
term in indications
serious n=441NCT00637377: 3/309 (1.0%) on Ranibizumab (serious AE)
Conjunctival erosion31292.5
193.6–441.7ROR 292.8 · χ² 6,345 / p <1e-300
188.6 EB05 139.2 · IC025 +5.0
3/3 methods agree
Labeled — boxed warning
exact term
serious n=24 · 90% cliniciannot reported in cached trials
Subretinal haematoma12284.7
147.1–551.3ROR 284.9 · χ² 2,284 / p <1e-300
157.3 EB05 95.9 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials
Exudative retinopathy14274.1
149.1–503.7ROR 274.2 · χ² 2,623 / p <1e-300
159.5 EB05 101.0 · IC025 +3.8
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=14not reported in cached trials
Cataract traumatic10244.7
120.3–497.7ROR 244.8 · χ² 1,668 / p <1e-300
138.1 EB05 80.2 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Retinal neovascularisation58240.3
179.1–322.4ROR 240.8 · χ² 10,394 / p <1e-300
173.7 EB05 139.3 · IC025 +5.7
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=58not reported in cached trials
Macular cyst17208.0
121.9–355.0ROR 208.1 · χ² 2,606 / p <1e-300
139.2 EB05 92.0 · IC025 +4.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=17NCT00637377: 1/307 (0.3%) on Ranibizumab (serious AE)
Retinopathy of prematurity107192.2
155.6–237.3ROR 192.9 · χ² 16,186 / p <1e-300
150.4 EB05 128.0 · IC025 +6.2
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=107 · 100% cliniciannot reported in cached trials
Retinal depigmentation58186.1
139.8–247.8ROR 186.5 · χ² 8,480 / p <1e-300
143.5 EB05 115.1 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=57 · 93% cliniciannot reported in cached trials
Pseudoendophthalmitis19186.0
112.8–306.6ROR 186.1 · χ² 2,677 / p <1e-300
131.0 EB05 88.6 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=19NCT00509795: 1/304 (0.3%) on Ranibizumab (serious AE)
Macular ischaemia27176.2
116.1–267.4ROR 176.4 · χ² 3,698 / p <1e-300
130.9 EB05 94.5 · IC025 +4.7
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=27 · 100% cliniciannot reported in cached trials
Retinal aneurysm35168.1
116.7–242.2ROR 168.4 · χ² 4,650 / p <1e-300
129.0 EB05 97.0 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=35 · 100% cliniciannot reported in cached trials
Vitreous haemorrhage454155.7
140.8–172.0ROR 158.4 · χ² 58,072 / p <1e-300
129.3 EB05 119.6 · IC025 +6.7
3/3 methods agree
Labeled — boxed warning
exact term
serious n=438NCT00637377: 1/291 (0.3%) on Ranibizumab (serious AE)
Retinal exudates146146.9
123.2–175.3ROR 147.8 · χ² 17,697 / p <1e-300
121.9 EB05 106.2 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=145not reported in cached trials
Retinal drusen25146.1
95.3–223.9ROR 146.2 · χ² 2,915 / p <1e-300
112.9 EB05 80.4 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=25not reported in cached trials
Macular pigmentation13143.4
79.4–258.9ROR 143.4 · χ² 1,435 / p <1e-300
103.4 EB05 64.3 · IC025 +3.5
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=12not reported in cached trials
Vitreous adhesions17138.7
82.8–232.2ROR 138.8 · χ² 1,859 / p <1e-300
104.4 EB05 69.1 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Neovascular age-related macular degeneration197132.0
113.5–153.4ROR 132.9 · χ² 21,801 / p <1e-300
111.9 EB05 99.4 · IC025 +6.2
3/3 methods agree
Likely indication confounding
term in indications
serious n=191not reported in cached trials
Choroidal haemorrhage25117.2
77.0–178.4ROR 117.3 · χ² 2,406 / p <1e-300
94.9 EB05 67.6 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=25NCT00509795: 1/304 (0.3%) on Ranibizumab (serious AE)
Macular fibrosis86114.3
91.2–143.3ROR 114.7 · χ² 8,332 / p <1e-300
97.8 EB05 81.6 · IC025 +5.6
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=85not reported in cached trials
Ophthalmological examination abnormal22114.1
73.0–178.4ROR 114.2 · χ² 2,055 / p <1e-300
92.0 EB05 64.0 · IC025 +4.3
3/3 methods agree
Reporting / coding artifactserious n=20not reported in cached trials
Posterior capsule rupture10113.5
58.5–220.3ROR 113.5 · χ² 878 / p 3e-193
83.9 EB05 48.7 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Pseudophakia10111.9
57.7–217.0ROR 111.9 · χ² 867 / p 8e-191
83.0 EB05 48.2 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Ranibizumab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (12 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Death3,8003.5
3.4–3.6ROR 3.9 · χ² 7,103 / p <1e-300
3.5 EB05 3.4 · IC025 +1.8
3/3 methods agree
Outcome field, not a reactionserious PRR 2.4NCT00637377: 1/297 (0.3%) on Ranibizumab (serious AE)
Visual acuity reduced2,90675.5
72.8–78.3ROR 84.7 · χ² 195,055 / p <1e-300
68.9 EB05 66.8 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious PRR 60.4NCT00637377: 3/291 (1.0%) on Ranibizumab (serious AE)
Off label use (used outside approved label)1,7221.6
1.5–1.7ROR 1.6 · χ² 379 / p 1e-84
1.6 EB05 1.5 · IC025 +0.6Reporting / coding artifactserious PRR 1.1not reported in cached trials
Visual impairment1,64710.8
10.3–11.3ROR 11.4 · χ² 14,473 / p <1e-300
10.6 EB05 10.2 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious PRR 9.6not reported in cached trials
Cerebrovascular accident (stroke)1,2385.8
5.5–6.1ROR 6.1 · χ² 4,941 / p <1e-300
5.8 EB05 5.5 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious PRR 3.9NCT00637377: 2/291 (0.7%) on Ranibizumab (serious AE)
Drug ineffective (drug did not work)1,2090.7
0.7–0.8ROR 0.7 · χ² 129 / p 3e-30
0.7 EB05 0.7 · IC025 -0.5
PRR-only: not supported by EBGM or IC
Reporting / coding artifactserious PRR 1.0not reported in cached trials
No adverse event1,0534.7
4.5–5.0ROR 4.9 · χ² 3,111 / p <1e-300
4.7 EB05 4.5 · IC025 +2.1
3/3 methods agree
Reporting / coding artifactserious PRR 4.8not reported in cached trials
Blindness1,04620.9
19.7–22.2ROR 21.8 · χ² 19,353 / p <1e-300
20.4 EB05 19.4 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious PRR 14.0NCT00637377: 1/307 (0.3%) on Ranibizumab (serious AE)
Vision blurred (blurred vision)1,0326.0
5.7–6.4ROR 6.2 · χ² 4,331 / p <1e-300
6.0 EB05 5.7 · IC025 +2.5
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 6.1NCT00509795: 12/304 (3.9%) on Ranibizumab
Eye pain96114.1
13.2–15.0ROR 14.5 · χ² 11,465 / p <1e-300
13.8 EB05 13.1 · IC025 +3.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 16.0NCT00637377: 1/309 (0.3%) on Ranibizumab (serious AE)
Endophthalmitis734110.9
102.7–119.6ROR 114.0 · χ² 69,918 / p <1e-300
97.0 EB05 91.2 · IC025 +6.4
3/3 methods agree
Labeled — boxed warning
exact term
serious n=704 · 92% clinicianNCT00637377: 1/309 (0.3%) on Ranibizumab (serious AE)
Myocardial infarction (heart attack)6903.1
2.9–3.4ROR 3.2 · χ² 1,000 / p 9e-220
3.1 EB05 2.9 · IC025 +1.5
3/3 methods agree
Not in label — unassessedserious PRR 2.1NCT00637377: 1/291 (0.3%) on Ranibizumab (serious AE)
Cataract6869.3
8.6–10.0ROR 9.5 · χ² 5,019 / p <1e-300
9.2 EB05 8.6 · IC025 +3.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 6.6NCT00637377: 5/291 (1.7%) on Ranibizumab (serious AE)

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.

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 Ranibizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Ranibizumab are visual acuity reduced, visual impairment, cerebrovascular accident, blindness, eye haemorrhage, vision blurred. 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 Ranibizumab have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions.

Do FAERS signals prove that Ranibizumab 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

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.