Trastuzumab side effects: what 68,236 FDA adverse event reports show
Drug class
HER2/neu Receptor Antagonist
Label matched
Ontruzant (Ontruzant)
Who reports
68,236 reports · 86% serious · 8,219 with death outcome · 93% female
Used for
Ontruzant is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ).
What it is
Trastuzumab-dttb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dttb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.
Boxed warning
CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for comple.
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.
- 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). 1,183 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 |
|---|---|---|---|---|---|---|
| Computerised tomogram thorax | 38 | 522.0 308.8–882.5ROR 522.3 · calibrated p 1e-12 ✓ | 175.3 EB05 133.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=38 · 100% clinician | not reported in cached trials |
| Her2 positive breast cancer | 229 | 512.7 414.5–634.1ROR 514.4 · calibrated p 8e-14 ✓ | 187.8 EB05 168.3 · IC025 +6.9 3/3 methods agree | Likely indication confounding term in indications | serious n=229 · 97% clinician | not reported in cached trials |
| Her-2 positive breast cancer | 69 | 289.6 208.2–402.9ROR 289.9 · calibrated p 4e-11 ✓ | 142.6 EB05 116.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=63 | not reported in cached trials |
| Biopsy lung abnormal | 33 | 148.9 98.1–225.8ROR 148.9 · calibrated p 2e-8 ✓ | 94.7 EB05 70.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | not reported in cached trials |
| Lacrimal structure injury | 80 | 82.5 64.5–105.7ROR 82.6 · calibrated p 7e-7 ✓ | 64.1 EB05 53.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Nail toxicity | 55 | 69.6 51.9–93.2ROR 69.6 · calibrated p 2e-6 ✓ | 55.7 EB05 44.4 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=53 | not reported in cached trials |
| Hair disorder | 1,370 | 60.4 57.0–64.0ROR 61.6 · calibrated p 4e-6 ✓ | 50.5 EB05 48.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=33 | not reported in cached trials |
| Metastases to skin | 168 | 60.2 51.0–71.1ROR 60.4 · calibrated p 5e-6 ✓ | 50.1 EB05 44.1 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=166 | not reported in cached trials |
| Delusion of grandeur | 69 | 55.9 43.3–72.3ROR 56.0 · calibrated p 9e-6 ✓ | 46.8 EB05 38.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 0% (drug 93%) | not reported in cached trials |
| Nail bed inflammation | 47 | 53.2 39.0–72.5ROR 53.2 · calibrated p 1e-5 ✓ | 44.6 EB05 34.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=44 | not reported in cached trials |
| Psychological trauma | 1,263 | 51.8 48.8–55.0ROR 52.8 · calibrated p 1e-5 ✓ | 44.4 EB05 42.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.9 · 100% consumer | not reported in cached trials |
| Computerised tomogram thorax abnormal | 98 | 50.2 40.5–62.2ROR 50.3 · calibrated p 2e-5 ✓ | 42.9 EB05 36.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=98 · 92% clinician | not reported in cached trials |
| Cardiotoxicity | 1,202 | 48.1 45.3–51.1ROR 49.0 · calibrated p 2e-5 ✓ | 41.6 EB05 39.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 92% clinician | not reported in cached trials |
| Ejection fraction decreased | 2,048 | 46.5 44.4–48.7ROR 47.9 · calibrated p 2e-5 ✓ | 40.4 EB05 39.0 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.0 | NCT00490139: 1/2,076 (0.0%) on Trastuzumab (serious AE) |
| Metastases to central nervous system | 1,565 | 42.7 40.5–45.0ROR 43.7 · calibrated p 3e-5 ✓ | 37.5 EB05 36.0 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.1 | NCT00490139: 1/2,061 (0.0%) on Trastuzumab (serious AE) |
| Madarosis | 1,429 | 42.7 40.4–45.1ROR 43.5 · calibrated p 3e-5 ✓ | 37.5 EB05 35.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=182 | not reported in cached trials |
| Sarcoid-like reaction | 28 | 42.1 28.4–62.5ROR 42.1 · calibrated p 7e-5 ✓ | 36.2 EB05 26.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | not reported in cached trials |
| Hair colour changes | 1,509 | 41.8 39.7–44.1ROR 42.7 · calibrated p 4e-5 ✓ | 36.8 EB05 35.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=164 | not reported in cached trials |
| Breast cancer recurrent | 363 | 39.9 35.8–44.5ROR 40.1 · calibrated p 5e-5 ✓ | 35.3 EB05 32.4 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=356 | not reported in cached trials |
| Hair texture abnormal | 1,508 | 38.6 36.6–40.7ROR 39.4 · calibrated p 6e-5 ✓ | 34.3 EB05 32.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=164 | not reported in cached trials |
| Metastases to breast | 36 | 37.9 26.8–53.6ROR 37.9 · calibrated p 1e-4 ✓ | 33.3 EB05 25.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=36 | not reported in cached trials |
| Nail dystrophy | 61 | 37.9 29.0–49.4ROR 37.9 · calibrated p 9e-5 ✓ | 33.4 EB05 27.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=58 · 100% clinician | not reported in cached trials |
| Cardiac dysfunction | 398 | 37.4 33.7–41.5ROR 37.7 · calibrated p 8e-5 ✓ | 33.4 EB05 30.7 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious n=365 | not reported in cached trials |
| Radiation necrosis | 60 | 36.1 27.6–47.2ROR 36.2 · calibrated p 1e-4 ✓ | 32.1 EB05 25.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=60 · 100% clinician | not reported in cached trials |
| Alopecia totalis | 34 | 35.0 24.5–49.8ROR 35.0 · calibrated p 2e-4 ✓ | 30.9 EB05 23.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=31 | not reported in cached trials |
| Recall phenomenon | 81 | 32.9 26.2–41.4ROR 32.9 · calibrated p 2e-4 ✓ | 29.6 EB05 24.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=78 · 100% clinician | not reported in cached trials |
| Ejection fraction | 56 | 32.5 24.7–42.8ROR 32.5 · calibrated p 2e-4 ✓ | 29.2 EB05 23.3 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious n=52 | NCT00490139: 1/2,076 (0.0%) on Trastuzumab (serious AE) |
| Breast cancer metastatic | 985 | 31.0 29.0–33.1ROR 31.4 · calibrated p 2e-4 ✓ | 28.2 EB05 26.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 19.1 | not reported in cached trials |
| Myelosuppression | 3,069 | 30.4 29.3–31.5ROR 31.8 · calibrated p 2e-4 ✓ | 27.7 EB05 26.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · 99% clinician | NCT01358877: 2/2,364 (0.1%) on Trastuzumab; 3/2,405 (0.1%) control (serious AE) |
| Metastases to chest wall | 31 | 30.1 20.8–43.6ROR 30.1 · calibrated p 4e-4 ✓ | 27.1 EB05 20.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Onycholysis | 136 | 29.4 24.7–35.1ROR 29.5 · calibrated p 3e-4 ✓ | 26.8 EB05 23.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=120 | not reported in cached trials |
| Gastrointestinal anastomotic leak | 32 | 27.2 18.9–39.0ROR 27.2 · calibrated p 7e-4 ✓ | 24.7 EB05 18.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 93%) · 100% clinician | not reported in cached trials |
| Dacryostenosis acquired | 105 | 27.0 22.1–33.0ROR 27.0 · calibrated p 5e-4 ✓ | 24.8 EB05 21.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=70 | not reported in cached trials |
| Lymphangiosis carcinomatosa | 81 | 25.8 20.6–32.4ROR 25.9 · calibrated p 7e-4 ✓ | 23.8 EB05 19.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=80 · 100% clinician | not reported in cached trials |
| Left ventricular dysfunction | 515 | 25.7 23.5–28.1ROR 25.9 · calibrated p 6e-4 ✓ | 23.7 EB05 22.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=494 · 91% clinician | NCT00490139: 4/2,076 (0.2%) on Trastuzumab (serious AE) |
| Nasal mucosal disorder | 43 | 24.3 17.8–33.2ROR 24.4 · calibrated p 0.001 ✓ | 22.4 EB05 17.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=41 | not reported in cached trials |
| Onychalgia | 73 | 24.1 19.0–30.6ROR 24.1 · calibrated p 9e-4 ✓ | 22.3 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=64 | not reported in cached trials |
| Metastases to the mediastinum | 30 | 23.9 16.5–34.6ROR 23.9 · calibrated p 0.001 ✓ | 21.9 EB05 16.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Breast neoplasm | 74 | 23.7 18.7–30.0ROR 23.7 · calibrated p 0.001 ✓ | 22.0 EB05 18.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=72 | NCT00490139: 1/2,076 (0.0%) on Trastuzumab (serious AE) |
| Radiation skin injury | 81 | 23.0 18.3–28.8ROR 23.0 · calibrated p 0.001 ✓ | 21.3 EB05 17.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=78 · 91% clinician | NCT00490139: 1/2,076 (0.0%) on Trastuzumab (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Trastuzumab 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 (7 of 40 signal terms matched).
- NCT00490139 — ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D (N=8381, PHASE3; 530 AE terms posted; arms: Lapatinib Plus Trastuzumab; Trastuzumab Followed by Lapatinib; Lapatinib; Trastuzumab)
- 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)
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) | 6,771 | 3.3 3.2–3.3ROR 3.5 · calibrated p 0.483 | 3.2 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT00490139: 9/2,076 (0.4%) on Trastuzumab (serious AE) |
| Alopecia (hair loss) | 5,007 | 8.0 7.8–8.2ROR 8.6 · calibrated p 0.054 | 7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | NCT00490139: 151/2,076 (7.3%) on Trastuzumab |
| Nausea | 4,590 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.859 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00490139: 6/2,076 (0.3%) on Trastuzumab (serious AE) |
| Fatigue (tiredness) | 4,370 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.820 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00490139: 1/2,056 (0.0%) on Trastuzumab (serious AE) |
| Off label use (used outside approved label) | 4,316 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.685 | 1.5 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Death | 3,614 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.513 | 1.3 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.9 | NCT00490139: 1/2,056 (0.0%) on Trastuzumab (serious AE) |
| Disease progression | 3,549 | 9.5 9.2–9.8ROR 10.0 · calibrated p 0.033 ✓ | 9.2 EB05 9.0 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | not reported in cached trials |
| Vomiting | 3,070 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.980 | 2.0 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00490139: 8/2,076 (0.4%) on Trastuzumab (serious AE) |
| Myelosuppression | 3,069 | 30.4 29.3–31.5ROR 31.8 · calibrated p 2e-4 ✓ | 27.7 EB05 26.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · 99% clinician | NCT01358877: 2/2,364 (0.1%) on Trastuzumab; 3/2,405 (0.1%) control (serious AE) |
| Dyspnoea (shortness of breath) | 2,829 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.683 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled — boxed warning exact term | serious PRR 1.4 | NCT00490139: 6/2,076 (0.3%) on Trastuzumab (serious AE) |
| Pyrexia (fever) | 2,602 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.870 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00490139: 5/2,076 (0.2%) on Trastuzumab (serious AE) |
| Asthenia (weakness) | 2,332 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.913 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00490139: 1/2,076 (0.0%) on Trastuzumab (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 2,238 | 5.1 4.9–5.4ROR 5.3 · calibrated p 0.206 | 5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.5 · 94% clinician | NCT00490139: 3/2,076 (0.1%) on Trastuzumab (serious AE) |
| Neuropathy peripheral (nerve damage in hands/feet) | 2,137 | 7.1 6.8–7.4ROR 7.3 · calibrated p 0.088 | 6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | NCT00490139: 1/2,076 (0.0%) on Trastuzumab (serious AE) |
| Pain | 2,065 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.328 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00490139: 2/2,076 (0.1%) on Trastuzumab (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.
- Computerised tomogram thorax — n=38, PRR 522.0
- Her-2 positive breast cancer — n=69, PRR 289.6
- Biopsy lung abnormal — n=33, PRR 148.9
- Lacrimal structure injury — n=80, PRR 82.5
- Hair disorder — n=1,370, PRR 60.4
- Delusion of grandeur — n=69, PRR 55.9
- Psychological trauma — n=1,263, PRR 51.8
- Computerised tomogram thorax abnormal — n=98, PRR 50.2
- Cardiotoxicity — n=1,202, PRR 48.1
- Madarosis — n=1,429, PRR 42.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Trastuzumab ↔ Cardiotoxicity / heart failure.
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 Trastuzumab?
In FDA FAERS, the most frequently co-reported reaction terms for Trastuzumab are diarrhoea, alopecia, nausea, fatigue, vomiting, myelosuppression. 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 Trastuzumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for comple.
Do FAERS signals prove that Trastuzumab 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 ce2a2492-85e3-4b0a-872a-047f44e4203d, effective 20260420; matched on
openfda.generic_name.exact:"TRASTUZUMAB") - 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, 1,223 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
TRASTUZUMAB, 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.