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Panitumumab side effects: what 15,571 FDA adverse event reports show

Panitumumab · Vectibix · 1,020 reaction terms · 52,810 drug–reaction co-reports · data 2026-09-14
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Drug class

Epidermal Growth Factor Receptor Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Vectibix

openFDA label

Who reports

15,571 reports · 87% serious · 2,610 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC): In combination with FOLFOX for first-line treatment.

FDA label, Indications and Usage

What it is

Panitumumab is an epidermal growth factor receptor (EGFR) antagonist for intravenous use. Panitumumab is a human IgG2 kappa monoclonal antibody with an approximate molecular weight of 147 kDa that is produced in genetically engineered mammalian (Chinese hamster ovary) cells.

FDA label, Description section

Boxed warning

DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .

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 1Labeled adverse reaction 6Labeled (related wording) 6Likely indication confounding 3Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 20
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. 980 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
Trichomegaly35815.3
535.4–1,241.6ROR 817.1 · χ² 17,135 / p <1e-300
395.8 EB05 297.5 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious n=33 · 94% cliniciannot reported in cached trials
Depilation11730.3
350.0–1,523.8ROR 730.8 · χ² 4,708 / p <1e-300
259.4 EB05 154.5 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Colorectal cancer metastatic768684.4
628.2–745.6ROR 719.8 · χ² 345,403 / p <1e-300
446.9 EB05 421.0 · IC025 +8.3
3/3 methods agree
Likely indication confounding
term in indications
serious n=768NCT00339183: 9/587 (1.5%) on Panitumumab (serious AE)
Dermatitis acneiform1,048282.6
264.9–301.5ROR 302.9 · χ² 242,298 / p <1e-300
232.2 EB05 220.6 · IC025 +7.6
3/3 methods agree
Labeled adverse reaction
exact term
serious n=965 · 95% clinicianNCT02089737: 14/1,831 (0.8%) on Panitumumab (serious AE)
Skin toxicity906261.5
244.0–280.3ROR 277.6 · χ² 196,266 / p <1e-300
217.6 EB05 206.0 · IC025 +7.5
3/3 methods agree
Labeled adverse reaction
exact term
serious n=840NCT00339183: 3/587 (0.5%) on Panitumumab (serious AE)
Xeroderma43254.9
184.0–353.1ROR 255.6 · χ² 8,911 / p <1e-300
195.5 EB05 151.2 · IC025 +5.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=42 · ♀ 62% (drug 38%) · 100% cliniciannot reported in cached trials
Paronychia580208.6
191.4–227.4ROR 216.7 · χ² 103,421 / p <1e-300
179.4 EB05 167.5 · IC025 +7.2
3/3 methods agree
Labeled — boxed warning
exact term
serious n=545 · 95% clinicianNCT02089737: 5/1,831 (0.3%) on Panitumumab (serious AE)
Rectal cancer metastatic41180.9
130.6–250.5ROR 181.3 · χ² 6,297 / p <1e-300
148.4 EB05 114.1 · IC025 +5.3
3/3 methods agree
Likely indication confounding
term in indications
serious n=41 · 100% clinicianNCT00339183: 9/587 (1.5%) on Panitumumab (serious AE)
Transient aphasia13148.8
83.9–263.9ROR 148.9 · χ² 1,586 / p <1e-300
112.3 EB05 69.8 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials
Hepatectomy28136.2
92.3–200.9ROR 136.4 · χ² 3,286 / p <1e-300
114.2 EB05 82.9 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=28 · 93% cliniciannot reported in cached trials
Colorectal adenocarcinoma17110.6
67.5–181.4ROR 110.8 · χ² 1,605 / p <1e-300
92.0 EB05 60.8 · IC025 +3.9
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=17not reported in cached trials
Adenocarcinoma metastatic14103.8
60.3–178.9ROR 103.9 · χ² 1,229 / p 2e-269
85.5 EB05 54.1 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Eyelash changes12101.5
56.4–182.5ROR 101.6 · χ² 1,018 / p 1e-223
82.4 EB05 50.2 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials
Colon cancer recurrent1789.2
54.6–145.8ROR 89.3 · χ² 1,308 / p 1e-286
76.7 EB05 50.7 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Xerosis7689.1
70.7–112.4ROR 89.6 · χ² 6,125 / p <1e-300
81.9 EB05 67.6 · IC025 +5.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=76 · 96% cliniciannot reported in cached trials
Hypomagnesaemia82885.5
79.8–91.5ROR 90.2 · χ² 64,900 / p <1e-300
80.2 EB05 75.7 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious PRR 48.3 · 93% clinicianNCT02089737: 10/1,831 (0.5%) on Panitumumab (serious AE)
Adenocarcinoma of colon10781.5
67.1–99.0ROR 82.1 · χ² 7,942 / p <1e-300
75.8 EB05 64.5 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious n=107 · 98% cliniciannot reported in cached trials
Ectropion1981.1
51.1–128.9ROR 81.2 · χ² 1,342 / p 4e-294
71.2 EB05 48.2 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=18not reported in cached trials
Colon cancer metastatic8373.4
58.9–91.5ROR 73.8 · χ² 5,547 / p <1e-300
68.5 EB05 57.0 · IC025 +5.3
3/3 methods agree
Not in label — unassessedserious n=83NCT00339183: 2/587 (0.3%) on Panitumumab (serious AE)
Growth of eyelashes4173.1
53.4–100.0ROR 73.3 · χ² 2,695 / p <1e-300
67.2 EB05 51.7 · IC025 +4.7
3/3 methods agree
Labeled adverse reaction
exact term
serious n=30not reported in cached trials
Metastases to ovary1671.5
43.3–118.3ROR 71.6 · χ² 990 / p 1e-217
63.1 EB05 41.2 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=16not reported in cached trials
Liver operation1569.9
41.6–117.4ROR 69.9 · χ² 903 / p 1e-198
61.5 EB05 39.6 · IC025 +3.5
3/3 methods agree
Reporting / coding artifactserious n=15NCT00339183: 1/594 (0.2%) on Panitumumab (serious AE)
Carcinoembryonic antigen increased9368.1
55.3–83.8ROR 68.5 · χ² 5,786 / p <1e-300
64.0 EB05 53.8 · IC025 +5.3
3/3 methods agree
Lab value / disease markerserious n=88not reported in cached trials
Rectal adenocarcinoma2763.7
43.3–93.7ROR 63.8 · χ² 1,530 / p <1e-300
58.4 EB05 42.2 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=27 · 100% cliniciannot reported in cached trials
Rash pustular32662.7
56.2–70.0ROR 64.1 · χ² 18,858 / p <1e-300
59.7 EB05 54.5 · IC025 +5.6
3/3 methods agree
Labeled adverse reaction
exact term
serious n=307not reported in cached trials
Carbohydrate antigen 19-9 increased2054.0
34.5–84.4ROR 54.0 · χ² 949 / p 1e-208
49.6 EB05 33.9 · IC025 +3.8
3/3 methods agree
Lab value / disease markerserious n=20 · 100% cliniciannot reported in cached trials
Catheter site thrombosis1051.9
27.6–97.5ROR 51.9 · χ² 432 / p 2e-96
45.9 EB05 26.6 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=10NCT00339183: 1/587 (0.2%) on Panitumumab (serious AE)
Dermatitis infected1850.3
31.4–80.5ROR 50.4 · χ² 791 / p 2e-174
46.3 EB05 31.0 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Therapy partial responder46342.7
39.0–46.8ROR 44.0 · χ² 18,235 / p <1e-300
41.3 EB05 38.3 · IC025 +5.2
3/3 methods agree
Reporting / coding artifactserious PRR 32.7 · 99% cliniciannot reported in cached trials
Pyogenic granuloma1338.8
22.4–67.3ROR 38.8 · χ² 429 / p 1e-95
35.9 EB05 22.3 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials
Metastases to pelvis1737.2
23.0–60.3ROR 37.3 · χ² 549 / p 1e-121
35.0 EB05 23.1 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Metastases to peritoneum6535.9
28.0–45.8ROR 36.0 · χ² 2,111 / p <1e-300
34.6 EB05 28.1 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=65 · 95% cliniciannot reported in cached trials
Metastases to liver43234.0
30.9–37.4ROR 34.9 · χ² 13,468 / p <1e-300
33.1 EB05 30.6 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious PRR 22.0NCT02089737: 1/1,254 (0.1%) on Panitumumab (serious AE)
Hypertrichosis4432.5
24.1–43.9ROR 32.6 · χ² 1,282 / p 5e-281
31.4 EB05 24.3 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=43not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Panitumumab 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 (10 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
Rash1,8765.8
5.6–6.1ROR 6.5 · χ² 7,658 / p <1e-300
5.8 EB05 5.6 · IC025 +2.5
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 6.4NCT02089737: 1/1,831 (0.1%) on Panitumumab (serious AE)
Diarrhoea (diarrhea)1,6143.4
3.2–3.5ROR 3.7 · χ² 2,788 / p <1e-300
3.4 EB05 3.2 · IC025 +1.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.7NCT02089737: 26/1,831 (1.4%) on Panitumumab (serious AE)
Dermatitis acneiform1,048282.6
264.9–301.5ROR 302.9 · χ² 242,298 / p <1e-300
232.2 EB05 220.6 · IC025 +7.6
3/3 methods agree
Labeled adverse reaction
exact term
serious n=965 · 95% clinicianNCT02089737: 14/1,831 (0.8%) on Panitumumab (serious AE)
Death9941.6
1.5–1.7ROR 1.6 · χ² 204 / p 1e-46
1.6 EB05 1.5 · IC025 +0.5Outcome field, not a reaction
boxed warning mentions mortality
serious PRR 1.0NCT02089737: 4/1,831 (0.2%) on Panitumumab (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))9299.3
8.7–9.9ROR 9.8 · χ² 6,861 / p <1e-300
9.2 EB05 8.7 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious PRR 6.3 · 95% clinicianNCT02089737: 17/1,831 (0.9%) on Panitumumab (serious AE)
Skin toxicity906261.5
244.0–280.3ROR 277.6 · χ² 196,266 / p <1e-300
217.6 EB05 206.0 · IC025 +7.5
3/3 methods agree
Labeled adverse reaction
exact term
serious n=840NCT00339183: 3/587 (0.5%) on Panitumumab (serious AE)
Nausea8381.4
1.3–1.5ROR 1.5 · χ² 112 / p 2e-26
1.4 EB05 1.4 · IC025 +0.4Labeled adverse reaction
exact term
serious PRR 1.7NCT02089737: 5/1,831 (0.3%) on Panitumumab (serious AE)
Hypomagnesaemia82885.5
79.8–91.5ROR 90.2 · χ² 64,900 / p <1e-300
80.2 EB05 75.7 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious PRR 48.3 · 93% clinicianNCT02089737: 10/1,831 (0.5%) on Panitumumab (serious AE)
Colorectal cancer metastatic768684.4
628.2–745.6ROR 719.8 · χ² 345,403 / p <1e-300
446.9 EB05 421.0 · IC025 +8.3
3/3 methods agree
Likely indication confounding
term in indications
serious n=768NCT00339183: 9/587 (1.5%) on Panitumumab (serious AE)
Disease progression7258.3
7.8–8.9ROR 8.7 · χ² 4,662 / p <1e-300
8.2 EB05 7.8 · IC025 +2.9
3/3 methods agree
Reporting / coding artifactserious PRR 5.7not reported in cached trials
Neuropathy peripheral (nerve damage in hands/feet)72410.4
9.7–11.2ROR 10.8 · χ² 6,111 / p <1e-300
10.3 EB05 9.7 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 7.8 · 92% clinicianNCT02089737: 1/1,831 (0.1%) on Panitumumab (serious AE)
Fatigue (tiredness)6941.2
1.1–1.3ROR 1.2 · χ² 24 / p 4e-7
1.2 EB05 1.1 · IC025 +0.1Labeled adverse reaction
exact term
serious PRR 1.3NCT02089737: 2/1,831 (0.1%) on Panitumumab (serious AE)
Off label use (used outside approved label)6861.1
1.0–1.1ROR 1.1 · χ² 3 / p 0.049
1.1 EB05 1.0 · IC025 -0.0
PRR-only: not supported by EBGM or IC
Reporting / coding artifactserious PRR 1.1not reported in cached trials
Dry skin6566.7
6.3–7.3ROR 7.0 · χ² 3,207 / p <1e-300
6.7 EB05 6.3 · IC025 +2.6
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 17.9NCT02089737: 1/1,254 (0.1%) on Panitumumab (serious AE)
Vomiting6431.8
1.7–2.0ROR 1.9 · χ² 255 / p 1e-57
1.8 EB05 1.7 · IC025 +0.8Labeled adverse reaction
exact term
serious PRR 1.7NCT02089737: 5/1,831 (0.3%) on Panitumumab (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 Panitumumab?

In FDA FAERS, the most frequently co-reported reaction terms for Panitumumab are rash, diarrhoea, dermatitis acneiform, neutropenia, skin toxicity, nausea. 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 Panitumumab have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .

Do FAERS signals prove that Panitumumab 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.