Pertuzumab side effects: what 27,021 FDA adverse event reports show

Pertuzumab · Perjeta · 1,097 reaction terms · 94,523 drug–reaction co-reports · data 2026-09-14

Drug class

HER2/neu Receptor Antagonist

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Perjeta

openFDA label

Who reports

27,021 reports · 85% serious · 2,685 with death outcome · 97% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

FDA label, Indications and Usage

What it is

Pertuzumab is a recombinant humanized monoclonal antibody and HER2/neu receptor antagonist that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2).

FDA label, Description section

Boxed warning

LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment.

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 adverse reaction 2Labeled (related wording) 2Likely indication confounding 1Lab value / disease marker 1Not in label — unassessed 34

What the badges mean

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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,057 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Her2 positive breast cancer	117	362.2 290.8–451.2ROR 363.8 · calibrated p 3e-12 ✓	236.6 EB05 202.8 · IC025 +6.6 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Likely indication confounding term in indications; also in warnings	serious n=117 · 97% clinician	not reported in cached trials
Hyperfibrinogenaemia	13	184.1 100.5–337.2ROR 184.2 · calibrated p 2e-8 ✓	122.3 EB05 76.1 · IC025 +3.6 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=13	not reported in cached trials
Lacrimal structure injury	59	143.7 108.8–189.7ROR 144.0 · calibrated p 1e-8 ✓	116.6 EB05 93.7 · IC025 +5.5 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=21	not reported in cached trials
Her-2 positive breast cancer	21	133.8 84.2–212.7ROR 133.9 · calibrated p 6e-8 ✓	103.5 EB05 71.4 · IC025 +4.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=20 · 90% clinician	not reported in cached trials
Nail bed inflammation	46	131.2 96.0–179.4ROR 131.5 · calibrated p 3e-8 ✓	107.3 EB05 83.7 · IC025 +5.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled (related wording) related wording	serious n=44	not reported in cached trials
Delusion of grandeur	63	127.1 97.4–165.9ROR 127.4 · calibrated p 3e-8 ✓	105.7 EB05 85.6 · IC025 +5.5 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=63 · ♀ 0% (drug 97%)	not reported in cached trials
Nail toxicity	38	113.5 80.7–159.5ROR 113.7 · calibrated p 1e-7 ✓	94.4 EB05 71.8 · IC025 +4.9 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled (related wording) related wording	serious n=37	not reported in cached trials
Sarcoid-like reaction	23	85.4 55.5–131.3ROR 85.4 · calibrated p 1e-6 ✓	72.5 EB05 50.8 · IC025 +4.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=21 · 100% clinician	not reported in cached trials
Nail dystrophy	48	73.4 54.6–98.7ROR 73.5 · calibrated p 2e-6 ✓	65.4 EB05 51.3 · IC025 +4.8 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=46 · 96% clinician	not reported in cached trials
Vascular fragility	12	66.0 36.6–119.0ROR 66.0 · calibrated p 1e-5 ✓	55.8 EB05 34.0 · IC025 +3.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=12	not reported in cached trials
Vessel puncture site bruise	14	59.1 34.3–101.9ROR 59.2 · calibrated p 2e-5 ✓	51.4 EB05 32.5 · IC025 +3.4 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=14	not reported in cached trials
Pseudocirrhosis	22	55.7 36.1–85.9ROR 55.7 · calibrated p 2e-5 ✓	49.9 EB05 34.7 · IC025 +3.9 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=22 · 91% clinician	not reported in cached trials
Nasal mucosal disorder	39	55.4 40.1–76.7ROR 55.5 · calibrated p 1e-5 ✓	50.5 EB05 38.6 · IC025 +4.4 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=39	not reported in cached trials
Bone marrow infiltration	24	51.4 34.0–77.7ROR 51.4 · calibrated p 2e-5 ✓	46.6 EB05 32.9 · IC025 +3.9 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=24 · 100% clinician	not reported in cached trials
Microvascular coronary artery disease	13	51.2 29.2–89.8ROR 51.3 · calibrated p 4e-5 ✓	45.1 EB05 28.1 · IC025 +3.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=13	not reported in cached trials
Dacryostenosis acquired	77	48.9 38.9–61.6ROR 49.1 · calibrated p 2e-5 ✓	45.6 EB05 37.7 · IC025 +4.8 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=47	not reported in cached trials
Granulomatous lymphadenitis	11	48.9 26.6–89.9ROR 48.9 · calibrated p 7e-5 ✓	42.9 EB05 25.5 · IC025 +2.9 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=11	not reported in cached trials
Metastases to soft tissue	15	47.2 28.0–79.5ROR 47.2 · calibrated p 6e-5 ✓	42.3 EB05 27.2 · IC025 +3.3 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=15	not reported in cached trials
Metastases to skin	58	46.5 35.7–60.6ROR 46.6 · calibrated p 3e-5 ✓	43.3 EB05 34.8 · IC025 +4.6 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=57	not reported in cached trials
Central vision loss	11	41.6 22.7–76.4ROR 41.7 · calibrated p 2e-4 ✓	37.2 EB05 22.1 · IC025 +2.9 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=11	not reported in cached trials
Metastases to central nervous system	641	40.8 37.8–44.2ROR 41.8 · calibrated p 4e-5 ✓	38.8 EB05 36.3 · IC025 +5.1 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 15.9 (11.8–21.3)	Not in label — unassessed	serious PRR 26.5	not reported in cached trials
Pneumonitis chemical	17	39.3 24.1–63.9ROR 39.3 · calibrated p 1e-4 ✓	36.0 EB05 23.8 · IC025 +3.4 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=17	not reported in cached trials
Alopecia totalis	16	39.2 23.7–64.8ROR 39.2 · calibrated p 1e-4 ✓	35.9 EB05 23.4 · IC025 +3.3 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=15	not reported in cached trials
Streptococcal sepsis	57	38.9 29.8–50.7ROR 39.0 · calibrated p 8e-5 ✓	36.6 EB05 29.3 · IC025 +4.4 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=57	not reported in cached trials
Biliary sepsis	22	38.8 25.3–59.5ROR 38.8 · calibrated p 1e-4 ✓	35.9 EB05 25.0 · IC025 +3.6 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=22 · 100% clinician	not reported in cached trials
Radiation skin injury	55	38.5 29.4–50.5ROR 38.6 · calibrated p 9e-5 ✓	36.3 EB05 29.0 · IC025 +4.3 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious n=53 · 94% clinician	NCT01358877: 1/2,364 (0.0%) on Pertuzumab (serious AE)
Breast neoplasm	48	37.9 28.4–50.6ROR 37.9 · calibrated p 1e-4 ✓	35.7 EB05 28.0 · IC025 +4.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=47	NCT01358877: 1/2,405 (0.0%) control (serious AE)
Ejection fraction decreased	717	37.4 34.8–40.3ROR 38.4 · calibrated p 7e-5 ✓	35.7 EB05 33.6 · IC025 +5.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 11.2 (8.8–14.2)	Labeled adverse reaction exact term	serious PRR 24.6 · 93% clinician	NCT01358877: 14/2,364 (0.6%) on Pertuzumab; 10/2,405 (0.4%) control (serious AE)
Lymphocyte count abnormal	52	37.4 28.3–49.4ROR 37.5 · calibrated p 1e-4 ✓	35.3 EB05 27.9 · IC025 +4.3 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Lab value / disease marker	serious n=52 · ♀ 0% (drug 97%) · 92% clinician	not reported in cached trials
Metastases to breast	15	37.2 22.2–62.5ROR 37.3 · calibrated p 2e-4 ✓	34.2 EB05 22.0 · IC025 +3.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=15	not reported in cached trials
Myelosuppression	1,555	37.1 35.3–39.0ROR 39.3 · calibrated p 6e-5 ✓	35.4 EB05 34.0 · IC025 +5.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 73.9 (49.8–109.7)	Not in label — unassessed	serious PRR 24.0 · 99% clinician	NCT01358877: 2/2,364 (0.1%) on Pertuzumab; 3/2,405 (0.1%) control (serious AE)
Gastroenteritis radiation	15	36.9 22.0–61.9ROR 36.9 · calibrated p 2e-4 ✓	33.9 EB05 21.8 · IC025 +3.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=15	not reported in cached trials
Catheter site bruise	13	36.3 20.8–63.3ROR 36.3 · calibrated p 3e-4 ✓	33.2 EB05 20.6 · IC025 +3.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=13	not reported in cached trials
Breast cancer recurrent	138	35.5 29.9–42.1ROR 35.7 · calibrated p 1e-4 ✓	33.8 EB05 29.3 · IC025 +4.6 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=136	not reported in cached trials
Mastectomy	75	34.8 27.6–43.8ROR 34.9 · calibrated p 1e-4 ✓	33.1 EB05 27.3 · IC025 +4.4 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=74	not reported in cached trials
Radiation necrosis	24	34.1 22.7–51.3ROR 34.1 · calibrated p 2e-4 ✓	32.0 EB05 22.6 · IC025 +3.6 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=24 · 100% clinician	not reported in cached trials
Recall phenomenon	35	33.9 24.2–47.5ROR 33.9 · calibrated p 2e-4 ✓	32.0 EB05 24.0 · IC025 +3.9 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=34 · 94% clinician	not reported in cached trials
Hyperproteinaemia	11	33.4 18.3–61.0ROR 33.4 · calibrated p 5e-4 ✓	30.5 EB05 18.1 · IC025 +2.7 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=11	not reported in cached trials
Meibomian gland dysfunction	18	33.0 20.6–52.9ROR 33.0 · calibrated p 3e-4 ✓	30.8 EB05 20.6 · IC025 +3.3 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=17	not reported in cached trials
Nodular regenerative hyperplasia	29	32.9 22.7–47.8ROR 33.0 · calibrated p 3e-4 ✓	31.1 EB05 22.7 · IC025 +3.8 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Not in label — unassessed	serious n=26	NCT01966471: 3/912 (0.3%) on Pertuzumab (serious AE)

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Pertuzumab 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 (5 of 40 signal terms matched).

NCT01358877 — A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Hum (N=4804, PHASE3; 600 AE terms posted; arms: Pertuzumab + Trastuzumab + Chemotherapy; Placebo + Trastuzumab + Chemotherapy)
NCT01966471 — A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison Wi (N=1846, PHASE3; 295 AE terms posted; arms: Anthracycline Followed by Trastuzumab, P; Anthracycline Followed by Trastuzumab Em)

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.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Diarrhoea (diarrhea)	3,802	4.6 4.5–4.7ROR 5.2 · calibrated p 0.214	4.6 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 11.2 (10.1–12.4)	Labeled adverse reaction exact term	serious PRR 4.6	NCT01358877: 58/2,364 (2.5%) on Pertuzumab; 18/2,405 (0.7%) control (serious AE)
Off label use (used outside approved label)	2,368	2.1 2.0–2.2ROR 2.2 · calibrated p 0.938	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 3.2 (2.9–3.4)	Reporting / coding artifact	serious PRR 2.3	not reported in cached trials
Nausea	1,958	1.9 1.8–2.0ROR 2.0 · calibrated p 0.944	1.9 EB05 1.9 · IC025 +0.9 vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 2.3	NCT01358877: 18/2,364 (0.8%) on Pertuzumab; 14/2,405 (0.6%) control (serious AE)
Fatigue (tiredness)	1,921	1.9 1.8–2.0ROR 2.0 · calibrated p 0.939	1.9 EB05 1.8 · IC025 +0.9 vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 2.2	NCT01358877: 7/2,364 (0.3%) on Pertuzumab; 5/2,405 (0.2%) control (serious AE)
Alopecia (hair loss)	1,569	6.2 5.9–6.5ROR 6.6 · calibrated p 0.119	6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 6.2	NCT01358877: 1594/2,364 (67.4%) on Pertuzumab; 1635/2,405 (68.0%) control
Myelosuppression	1,555	37.1 35.3–39.0ROR 39.3 · calibrated p 6e-5 ✓	35.4 EB05 34.0 · IC025 +5.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 73.9 (49.8–109.7)	Not in label — unassessed	serious PRR 24.0 · 99% clinician	NCT01358877: 2/2,364 (0.1%) on Pertuzumab; 3/2,405 (0.1%) control (serious AE)
Disease progression	1,336	8.9 8.4–9.4ROR 9.3 · calibrated p 0.041 ✓	8.8 EB05 8.4 · IC025 +3.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 11.8 (9.9–14.1)	Reporting / coding artifact	serious PRR 6.3	not reported in cached trials
Vomiting	1,298	2.2 2.0–2.3ROR 2.2 · calibrated p 0.947	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 2.0	NCT01358877: 19/2,364 (0.8%) on Pertuzumab; 15/2,405 (0.6%) control (serious AE)
Dyspnoea (shortness of breath)	1,197	1.6 1.6–1.7ROR 1.7 · calibrated p 0.753	1.6 EB05 1.6 · IC025 +0.6 vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 1.5	NCT01358877: 6/2,364 (0.3%) on Pertuzumab; 7/2,405 (0.3%) control (serious AE)
Neuropathy peripheral (nerve damage in hands/feet)	1,123	9.3 8.8–9.9ROR 9.7 · calibrated p 0.036 ✓	9.2 EB05 8.8 · IC025 +3.1 3/3 methods agree vs other HER2/neu Receptor Antagonists: PRR 19.9 (15.6–25.5)	Labeled adverse reaction exact term	serious PRR 6.5	NCT01358877: 1/2,364 (0.0%) on Pertuzumab (serious AE)
Death	1,104	1.0 0.9–1.1ROR 1.0 · calibrated p 0.303	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other HER2/neu Receptor Antagonists: only this drug	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 0.7	not reported in cached trials
Pyrexia (fever)	1,065	2.4 2.3–2.5ROR 2.4 · calibrated p 0.836	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 1.9	NCT01358877: 40/2,364 (1.7%) on Pertuzumab; 46/2,405 (1.9%) control (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))	1,006	5.8 5.5–6.2ROR 6.0 · calibrated p 0.151	5.7 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 4.0 · 95% clinician	NCT01358877: 211/2,364 (8.9%) on Pertuzumab; 196/2,405 (8.1%) control (serious AE)
Rash	940	1.7 1.6–1.8ROR 1.7 · calibrated p 0.774	1.7 EB05 1.6 · IC025 +0.6 vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 1.8	NCT01358877: 5/2,364 (0.2%) on Pertuzumab; 1/2,405 (0.0%) control (serious AE)
Anaemia (low red blood cells)	885	3.6 3.4–3.9ROR 3.7 · calibrated p 0.439	3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other HER2/neu Receptor Antagonists: only this drug	Labeled adverse reaction exact term	serious PRR 2.6 · 94% clinician	NCT01358877: 10/2,364 (0.4%) on Pertuzumab; 8/2,405 (0.3%) control (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.

Lacrimal structure injury — n=59, PRR 143.7
Her-2 positive breast cancer — n=21, PRR 133.8
Delusion of grandeur — n=63, PRR 127.1
Sarcoid-like reaction — n=23, PRR 85.4
Nail dystrophy — n=48, PRR 73.4
Pseudocirrhosis — n=22, PRR 55.7
Nasal mucosal disorder — n=39, PRR 55.4
Bone marrow infiltration — n=24, PRR 51.4
Dacryostenosis acquired — n=77, PRR 48.9
Metastases to skin — n=58, PRR 46.5

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 Pertuzumab?

In FDA FAERS, the most frequently co-reported reaction terms for Pertuzumab are diarrhoea, nausea, fatigue, alopecia, myelosuppression, vomiting. 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 Pertuzumab have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment.

Do FAERS signals prove that Pertuzumab 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 17f85d17-ab71-4f5b-9fe3-0b8c822f69ff, effective 20260430; matched on openfda.generic_name.exact:"PERTUZUMAB")
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, field patient.drug.openfda.generic_name.exact, 1,097 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
ClinicalTrials.gov API v2 (query PERTUZUMAB, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.