Drug · FAERS side-effect profile with label screen
Atezolizumab side effects: what 38,600 FDA adverse event reports show
Drug class
Programmed Death Receptor-1 Blocking Antibody
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Tecentriq
openFDA label
Who reports
38,600 reports · 96% serious · 9,820 with death outcome · 37% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test.
FDA label, Indications and Usage
What it is
Atezolizumab is a programmed cell death ligand 1 (PD-L1) blocking antibody. Atezolizumab is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa.
FDA label, Description section
Boxed warning
None in the current 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 5Labeled (related wording) 12Likely indication confounding 3Lab value / disease marker 2Not in label — unassessed 18
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). 1,041 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Systemic immune activation | 26 | 556.4 321.3–963.3ROR 556.8 · calibrated p 8e-13 ✓ | 227.7 EB05 163.3 · IC025 +4.8 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Labeled (related wording) related wording | not fetched | no trial data cached |
| Mixed hepatocellular cholangiocarcinoma | 22 | 511.7 285.2–918.0ROR 512.0 · calibrated p 3e-12 ✓ | 213.6 EB05 148.7 · IC025 +4.6 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Likely indication confounding shares a disease stem with the indications wording | not fetched | no trial data cached |
| Pharyngeal necrosis | 13 | 210.8 110.9–400.4ROR 210.8 · calibrated p 8e-9 ✓ | 124.3 EB05 77.3 · IC025 +3.6 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Labeled (related wording) related wording | not fetched | no trial data cached |
| Paraneoplastic neurological syndrome | 35 | 210.4 142.3–311.0ROR 210.6 · calibrated p 1e-9 ✓ | 139.9 EB05 105.1 · IC025 +5.0 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Alpha 1 foetoprotein decreased | 11 | 202.9 101.4–406.2ROR 203.0 · calibrated p 2e-8 ✓ | 117.8 EB05 70.2 · IC025 +3.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Lab value / disease marker | not fetched | no trial data cached |
| Reactive capillary endothelial proliferation | 14 | 187.2 101.9–344.1ROR 187.3 · calibrated p 1e-8 ✓ | 117.2 EB05 74.2 · IC025 +3.7 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Urinary occult blood | 11 | 154.9 79.2–302.9ROR 154.9 · calibrated p 9e-8 ✓ | 100.0 EB05 59.6 · IC025 +3.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Tumour fistulisation | 12 | 133.7 71.1–251.8ROR 133.8 · calibrated p 2e-7 ✓ | 92.0 EB05 56.1 · IC025 +3.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Endocrine toxicity | 18 | 118.9 71.3–198.1ROR 118.9 · calibrated p 2e-7 ✓ | 88.6 EB05 59.3 · IC025 +4.0 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 5.5 (3.2–9.5) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Tumour thrombosis | 38 | 108.7 76.7–154.1ROR 108.8 · calibrated p 1e-7 ✓ | 86.7 EB05 65.9 · IC025 +4.8 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Tumour hyperprogression | 30 | 79.5 54.2–116.6ROR 79.5 · calibrated p 1e-6 ✓ | 66.5 EB05 48.8 · IC025 +4.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.6 (2.4–5.3) | Not in label — unassessed | not fetched | no trial data cached |
| Bleeding varicose vein | 67 | 76.6 59.3–98.9ROR 76.7 · calibrated p 1e-6 ✓ | 65.9 EB05 53.7 · IC025 +5.1 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Liver carcinoma ruptured | 31 | 76.1 52.2–110.8ROR 76.1 · calibrated p 2e-6 ✓ | 64.2 EB05 47.4 · IC025 +4.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Varicose vein ruptured | 37 | 70.4 50.0–99.2ROR 70.5 · calibrated p 3e-6 ✓ | 60.5 EB05 45.8 · IC025 +4.6 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Immune-mediated encephalitis | 56 | 69.2 52.4–91.4ROR 69.3 · calibrated p 2e-6 ✓ | 60.2 EB05 48.1 · IC025 +4.9 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.1 (1.6–2.8) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Tumour inflammation | 12 | 69.0 37.8–125.9ROR 69.1 · calibrated p 1e-5 ✓ | 56.1 EB05 34.2 · IC025 +3.2 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Labeled (related wording) related wording | not fetched | no trial data cached |
| Tumour rupture | 58 | 63.6 48.4–83.5ROR 63.7 · calibrated p 4e-6 ✓ | 55.9 EB05 44.9 · IC025 +4.8 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Hepatocellular carcinoma | 791 | 62.8 58.4–67.5ROR 64.1 · calibrated p 3e-6 ✓ | 56.2 EB05 53.0 · IC025 +5.6 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 241.8 (179.9–324.9) | Likely indication confounding term in indications; also in warnings | not fetched | no trial data cached |
| Oesophageal varices haemorrhage | 221 | 61.4 53.4–70.5ROR 61.7 · calibrated p 4e-6 ✓ | 54.9 EB05 49.1 · IC025 +5.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Immune-mediated hepatitis | 188 | 57.5 49.5–66.8ROR 57.7 · calibrated p 6e-6 ✓ | 51.7 EB05 45.8 · IC025 +5.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.9 (1.6–2.2) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Hepatic rupture | 19 | 50.3 31.4–80.5ROR 50.3 · calibrated p 3e-5 ✓ | 44.2 EB05 29.9 · IC025 +3.6 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Alpha 1 foetoprotein increased | 59 | 48.9 37.4–63.8ROR 48.9 · calibrated p 2e-5 ✓ | 44.3 EB05 35.6 · IC025 +4.6 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Lab value / disease marker | not fetched | no trial data cached |
| Skin candida | 40 | 45.5 33.0–62.9ROR 45.6 · calibrated p 4e-5 ✓ | 41.3 EB05 31.6 · IC025 +4.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Immune-mediated neuropathy | 11 | 44.2 23.9–81.8ROR 44.3 · calibrated p 1e-4 ✓ | 38.4 EB05 22.9 · IC025 +2.9 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.5 (0.8–2.9) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Autoimmune nephritis | 16 | 43.0 25.8–71.6ROR 43.0 · calibrated p 9e-5 ✓ | 38.2 EB05 24.9 · IC025 +3.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.7 (1.0–2.9) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Hypophysitis | 146 | 42.4 35.9–50.2ROR 42.6 · calibrated p 4e-5 ✓ | 39.2 EB05 34.2 · IC025 +4.8 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.6 (1.4–1.9) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Triple negative breast cancer | 45 | 41.8 30.9–56.6ROR 41.8 · calibrated p 6e-5 ✓ | 38.3 EB05 29.8 · IC025 +4.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Thrombophlebitis migrans | 23 | 41.4 27.1–63.3ROR 41.5 · calibrated p 9e-5 ✓ | 37.4 EB05 26.3 · IC025 +3.7 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.3 (2.1–5.2) | Not in label — unassessed | not fetched | no trial data cached |
| Adrenocorticotropic hormone deficiency | 61 | 40.8 31.4–52.9ROR 40.9 · calibrated p 6e-5 ✓ | 37.6 EB05 30.3 · IC025 +4.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.3 (1.0–1.7) | Not in label — unassessed | not fetched | no trial data cached |
| Limbic encephalitis | 19 | 39.6 24.8–63.0ROR 39.6 · calibrated p 1e-4 ✓ | 35.7 EB05 24.2 · IC025 +3.5 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Tumour haemorrhage | 182 | 37.0 31.8–43.0ROR 37.2 · calibrated p 9e-5 ✓ | 34.6 EB05 30.5 · IC025 +4.7 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 8.7 (7.2–10.4) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Gastric varices haemorrhage | 21 | 36.7 23.6–57.1ROR 36.7 · calibrated p 2e-4 ✓ | 33.5 EB05 23.1 · IC025 +3.5 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Labeled (related wording) related wording | not fetched | no trial data cached |
| Autoimmune colitis | 40 | 36.0 26.1–49.5ROR 36.0 · calibrated p 1e-4 ✓ | 33.3 EB05 25.5 · IC025 +4.1 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.3 (1.0–1.8) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Encephalitis autoimmune | 79 | 35.3 28.1–44.3ROR 35.4 · calibrated p 1e-4 ✓ | 32.9 EB05 27.3 · IC025 +4.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 4.8 (3.7–6.2) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Infected neoplasm | 15 | 35.2 20.9–59.3ROR 35.2 · calibrated p 3e-4 ✓ | 31.9 EB05 20.5 · IC025 +3.2 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Not in label — unassessed | not fetched | no trial data cached |
| Nephritis | 196 | 34.2 29.6–39.4ROR 34.3 · calibrated p 1e-4 ✓ | 32.1 EB05 28.5 · IC025 +4.7 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.9 (3.3–4.5) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Immune-mediated pneumonitis | 14 | 34.0 19.8–58.4ROR 34.1 · calibrated p 3e-4 ✓ | 30.9 EB05 19.5 · IC025 +3.0 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.0 (0.6–1.8) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Immune-mediated lung disease | 103 | 34.0 27.8–41.4ROR 34.1 · calibrated p 2e-4 ✓ | 31.8 EB05 27.0 · IC025 +4.5 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.1 (0.9–1.3) | Labeled (related wording) related wording | not fetched | no trial data cached |
| Lymphocytic hypophysitis | 16 | 33.3 20.1–55.2ROR 33.3 · calibrated p 3e-4 ✓ | 30.4 EB05 19.8 · IC025 +3.2 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 1.3 (0.8–2.2) | Not in label — unassessed | not fetched | no trial data cached |
| Small cell lung cancer | 82 | 32.3 25.8–40.3ROR 32.3 · calibrated p 2e-4 ✓ | 30.3 EB05 25.2 · IC025 +4.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: only this drug | Likely indication confounding term in indications; also in warnings | not fetched | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Death | 4,264 | 2.7 2.6–2.8ROR 2.9 · calibrated p 0.657 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.4 (3.3–3.4) | Outcome field, not a reaction | not fetched | no trial data cached |
| Off label use (used outside approved label) | 3,584 | 2.2 2.2–2.3ROR 2.4 · calibrated p 0.868 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 4.6 (4.5–4.7) | Reporting / coding artifact | not fetched | no trial data cached |
| Disease progression | 2,163 | 10.1 9.7–10.6ROR 10.7 · calibrated p 0.026 ✓ | 10.0 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 17.8 (16.9–18.8) | Reporting / coding artifact | not fetched | no trial data cached |
| Pyrexia (fever) | 1,749 | 2.8 2.6–2.9ROR 2.8 · calibrated p 0.682 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.2 (3.1–3.4) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Diarrhoea (diarrhea) | 1,710 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.619 | 1.4 EB05 1.4 · IC025 +0.5 vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.2 (2.1–2.3) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Fatigue (tiredness) | 1,499 | 1.0 1.0–1.1ROR 1.1 · calibrated p 0.340 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.3 (2.2–2.4) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Anaemia (low red blood cells) | 1,351 | 3.9 3.7–4.1ROR 4.0 · calibrated p 0.384 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 4.5 (4.3–4.8) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Pneumonia (lung infection) | 1,134 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.909 | 1.9 EB05 1.8 · IC025 +0.8 vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.4 (3.2–3.6) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Decreased appetite (loss of appetite) | 1,110 | 2.6 2.5–2.8ROR 2.7 · calibrated p 0.748 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.5 (2.4–2.7) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Hypothyroidism | 1,079 | 19.0 17.9–20.2ROR 19.5 · calibrated p 0.002 ✓ | 18.4 EB05 17.5 · IC025 +4.1 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.0 (2.8–3.2) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Nausea | 1,062 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.142 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.2 (2.1–2.3) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Dyspnoea (shortness of breath) | 1,028 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.298 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.9 (2.7–3.0) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Hypertension (high blood pressure) | 996 | 2.6 2.4–2.7ROR 2.6 · calibrated p 0.772 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.4 (3.2–3.6) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Pneumonitis | 965 | 20.1 18.8–21.4ROR 20.6 · calibrated p 0.002 ✓ | 19.4 EB05 18.4 · IC025 +4.2 3/3 methods agree vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 3.1 (2.9–3.3) | Labeled adverse reaction exact term | not fetched | no trial data cached |
| Rash | 958 | 1.2 1.1–1.3ROR 1.2 · calibrated p 0.444 | 1.2 EB05 1.1 · IC025 +0.2 vs other Programmed Death Receptor-1 Blocking Antibodys: PRR 2.0 (1.9–2.1) | Labeled adverse reaction exact term | not fetched | 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.
- Paraneoplastic neurological syndrome — n=35, PRR 210.4
- Tumour thrombosis — n=38, PRR 108.7
- Tumour hyperprogression — n=30, PRR 79.5
- Bleeding varicose vein — n=67, PRR 76.6
- Liver carcinoma ruptured — n=31, PRR 76.1
- Varicose vein ruptured — n=37, PRR 70.4
- Tumour rupture — n=58, PRR 63.6
- Skin candida — n=40, PRR 45.5
- Triple negative breast cancer — n=45, PRR 41.8
- Thrombophlebitis migrans — n=23, PRR 41.4
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 Atezolizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Atezolizumab are pyrexia, diarrhoea, fatigue, anaemia, pneumonia, decreased appetite. 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 Atezolizumab have an FDA boxed warning?
No. The FDA label retrieved for Atezolizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atezolizumab 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 6fa682c9-a312-4932-9831-f286908660ee, effective 20260520; matched on
openfda.generic_name.exact:"ATEZOLIZUMAB") - 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, 1,081 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
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.