Drug · FAERS side-effect profile with label screen
Anastrozole side effects: what 36,494 FDA adverse event reports show
Who reports
36,494 reports · 68% serious · 2,430 with death outcome · 95% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Anastrozole tablets are an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) First-line treatment of postmenopausal women with hormone receptor-positive or hormone r.
FDA label, Indications and Usage
What it is
Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl).
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 1Labeled (related wording) 4Likely indication confounding 1Lab value / disease marker 6Not in label — unassessed 28
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). 1,183 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 |
|---|---|---|---|---|---|---|
| Amaurosis fugax | 224 | 152.4 131.5–176.5ROR 153.3 · calibrated p 5e-9 ✓ | 119.1 EB05 106.5 · IC025 +6.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.0 (0.8–1.1) | Not in label — unassessed | serious n=224 · 94% clinician | not reported in cached trials |
| Human rhinovirus test positive | 63 | 116.9 89.1–153.3ROR 117.1 · calibrated p 6e-8 ✓ | 94.4 EB05 76.4 · IC025 +5.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 4.9 (3.4–7.1) | Lab value / disease marker | serious n=63 | not reported in cached trials |
| Pik3ca-activated mutation | 50 | 104.0 77.0–140.6ROR 104.2 · calibrated p 2e-7 ✓ | 85.3 EB05 67.2 · IC025 +5.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.4 (0.3–0.6) | Not in label — unassessed | serious n=50 | not reported in cached trials |
| Pseudocirrhosis | 49 | 100.8 74.4–136.6ROR 101.0 · calibrated p 2e-7 ✓ | 83.1 EB05 65.3 · IC025 +5.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.1 (0.8–1.6) | Not in label — unassessed | serious n=49 · 100% clinician | not reported in cached trials |
| Carbohydrate antigen 15-3 increased | 98 | 84.8 68.6–104.8ROR 85.0 · calibrated p 5e-7 ✓ | 72.9 EB05 61.6 · IC025 +5.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.4–0.7) | Lab value / disease marker | serious n=97 | not reported in cached trials |
| Viral test positive | 45 | 80.3 58.8–109.8ROR 80.4 · calibrated p 1e-6 ✓ | 68.5 EB05 53.3 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 5.1 (3.3–8.0) | Lab value / disease marker | serious n=44 · 100% clinician | not reported in cached trials |
| Breast cancer recurrent | 370 | 76.4 68.6–85.1ROR 77.2 · calibrated p 8e-7 ✓ | 67.2 EB05 61.7 · IC025 +5.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.4 (1.2–1.6) | Not in label — unassessed | serious n=365 | not reported in cached trials |
| Pneumonia haemophilus | 51 | 67.1 50.2–89.7ROR 67.2 · calibrated p 3e-6 ✓ | 58.9 EB05 46.5 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 5.1 (3.4–7.7) | Not in label — unassessed | serious n=51 | not reported in cached trials |
| Metastases to chest wall | 36 | 66.6 47.1–94.0ROR 66.6 · calibrated p 4e-6 ✓ | 57.9 EB05 43.7 · IC025 +4.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.6–1.2) | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Metastases to thorax | 26 | 65.4 43.6–98.1ROR 65.4 · calibrated p 6e-6 ✓ | 56.4 EB05 40.5 · IC025 +4.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.6–1.4) | Not in label — unassessed | serious n=26 | not reported in cached trials |
| Metastases to breast | 32 | 62.2 43.2–89.6ROR 62.3 · calibrated p 6e-6 ✓ | 54.4 EB05 40.4 · IC025 +4.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 4.1 (2.5–6.8) | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Chest wall mass | 24 | 58.5 38.5–89.1ROR 58.6 · calibrated p 1e-5 ✓ | 51.1 EB05 36.2 · IC025 +4.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 4.4 (2.4–7.8) | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Respiratory syncytial virus test positive | 63 | 56.3 43.5–73.0ROR 56.4 · calibrated p 9e-6 ✓ | 50.6 EB05 40.9 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 4.8 (3.4–7.0) | Lab value / disease marker | serious n=63 | not reported in cached trials |
| Metastases to the mediastinum | 36 | 54.5 38.7–76.7ROR 54.5 · calibrated p 1e-5 ✓ | 48.6 EB05 36.7 · IC025 +4.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.6–1.2) | Not in label — unassessed | serious n=36 · 100% clinician | not reported in cached trials |
| Secondary hypogonadism | 25 | 47.3 31.5–71.2ROR 47.4 · calibrated p 4e-5 ✓ | 42.4 EB05 30.2 · IC025 +3.9 3/3 methods agree vs other Aromatase Inhibitors: PRR 4.0 (2.3–7.0) | Not in label — unassessed | serious n=25 · ♀ 0% (drug 95%) · 100% clinician | not reported in cached trials |
| Metastases to pelvis | 48 | 47.2 35.2–63.4ROR 47.3 · calibrated p 3e-5 ✓ | 43.0 EB05 33.7 · IC025 +4.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.7–1.2) | Not in label — unassessed | serious n=48 | not reported in cached trials |
| Hair disorder | 554 | 40.9 37.5–44.5ROR 41.5 · calibrated p 4e-5 ✓ | 38.1 EB05 35.5 · IC025 +5.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.5 (2.2–2.8) | Labeled (related wording) related wording | serious n=20 | not reported in cached trials |
| Metastases to bone | 1,080 | 40.6 38.2–43.1ROR 41.8 · calibrated p 4e-5 ✓ | 37.9 EB05 36.0 · IC025 +5.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.8) | Not in label — unassessed | serious PRR 32.2 | not reported in cached trials |
| Metastases to spine | 207 | 37.8 32.8–43.5ROR 38.0 · calibrated p 8e-5 ✓ | 35.4 EB05 31.5 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.8–1.1) | Not in label — unassessed | serious n=206 | not reported in cached trials |
| Trigger finger | 247 | 37.2 32.7–42.3ROR 37.4 · calibrated p 8e-5 ✓ | 34.9 EB05 31.4 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.0 (1.7–2.3) | Labeled adverse reaction exact term | serious n=163 | not reported in cached trials |
| Resorption bone increased | 44 | 32.6 24.0–44.1ROR 32.6 · calibrated p 2e-4 ✓ | 30.5 EB05 23.6 · IC025 +4.0 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Labeled (related wording) related wording | serious n=37 | not reported in cached trials |
| Vulvovaginal dryness | 171 | 32.2 27.6–37.6ROR 32.4 · calibrated p 2e-4 ✓ | 30.5 EB05 26.8 · IC025 +4.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.1 (1.7–2.5) | Not in label — unassessed | serious n=116 | not reported in cached trials |
| Tumour marker increased | 249 | 31.3 27.6–35.6ROR 31.5 · calibrated p 2e-4 ✓ | 29.7 EB05 26.7 · IC025 +4.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.6–0.8) | Lab value / disease marker | serious n=203 | not reported in cached trials |
| Breast cancer metastatic | 544 | 30.7 28.1–33.4ROR 31.1 · calibrated p 2e-4 ✓ | 29.1 EB05 27.1 · IC025 +4.7 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.4 (0.4–0.5) | Likely indication confounding term in indications | serious PRR 24.5 | not reported in cached trials |
| Primary sequestrum | 46 | 30.3 22.5–40.7ROR 30.3 · calibrated p 3e-4 ✓ | 28.5 EB05 22.2 · IC025 +4.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.5 (1.1–2.1) | Not in label — unassessed | serious n=46 | not reported in cached trials |
| Metastases to pleura | 51 | 29.5 22.3–39.1ROR 29.6 · calibrated p 4e-4 ✓ | 27.9 EB05 22.0 · IC025 +4.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.4–0.7) | Not in label — unassessed | serious n=51 · 100% clinician | not reported in cached trials |
| Sequestrectomy | 32 | 28.7 20.1–40.9ROR 28.7 · calibrated p 5e-4 ✓ | 26.9 EB05 20.0 · IC025 +3.7 3/3 methods agree vs other Aromatase Inhibitors: PRR 5.6 (3.3–9.5) | Not in label — unassessed | serious n=32 · 100% clinician | not reported in cached trials |
| Madarosis | 552 | 28.4 26.1–30.9ROR 28.8 · calibrated p 3e-4 ✓ | 27.1 EB05 25.2 · IC025 +4.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.1 (1.9–2.3) | Not in label — unassessed | serious n=60 | not reported in cached trials |
| Hair colour changes | 591 | 28.3 26.1–30.7ROR 28.7 · calibrated p 3e-4 ✓ | 27.0 EB05 25.2 · IC025 +4.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.4 (2.2–2.7) | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Invasive lobular breast carcinoma | 24 | 28.2 18.7–42.5ROR 28.2 · calibrated p 6e-4 ✓ | 26.4 EB05 18.7 · IC025 +3.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.3–0.8) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Hair texture abnormal | 630 | 28.1 26.0–30.4ROR 28.6 · calibrated p 3e-4 ✓ | 26.8 EB05 25.1 · IC025 +4.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.2 (2.0–2.4) | Not in label — unassessed | serious n=79 | not reported in cached trials |
| Blood oestrogen increased | 27 | 28.0 19.1–41.3ROR 28.1 · calibrated p 6e-4 ✓ | 26.3 EB05 19.0 · IC025 +3.5 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Lab value / disease marker | – | not reported in cached trials |
| Urinary tract disorder | 209 | 28.0 24.3–32.1ROR 28.1 · calibrated p 4e-4 ✓ | 26.6 EB05 23.7 · IC025 +4.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.0 (0.9–1.2) | Labeled (related wording) related wording | serious n=206 · 94% clinician | not reported in cached trials |
| Psychological trauma | 400 | 27.5 24.9–30.4ROR 27.8 · calibrated p 4e-4 ✓ | 26.3 EB05 24.2 · IC025 +4.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.5 (2.2–2.8) | Not in label — unassessed | serious PRR 22.2 · 100% consumer | not reported in cached trials |
| Atrophic vulvovaginitis | 32 | 26.4 18.5–37.6ROR 26.4 · calibrated p 7e-4 ✓ | 24.9 EB05 18.5 · IC025 +3.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.5 (1.0–2.2) | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Endometrial hyperplasia | 34 | 25.0 17.8–35.3ROR 25.0 · calibrated p 9e-4 ✓ | 23.7 EB05 17.7 · IC025 +3.6 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Metastases to lung | 478 | 24.8 22.6–27.1ROR 25.1 · calibrated p 7e-4 ✓ | 23.8 EB05 22.0 · IC025 +4.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.7–0.9) | Not in label — unassessed | serious PRR 20.2 | not reported in cached trials |
| Bone lesion | 148 | 24.5 20.8–28.9ROR 24.6 · calibrated p 8e-4 ✓ | 23.5 EB05 20.5 · IC025 +4.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.6–0.9) | Labeled (related wording) related wording | serious n=144 | not reported in cached trials |
| Osteosclerosis | 62 | 23.5 18.2–30.3ROR 23.5 · calibrated p 0.001 ✓ | 22.4 EB05 18.1 · IC025 +3.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.5–0.9) | Not in label — unassessed | serious n=61 | not reported in cached trials |
| Metastases to liver | 644 | 21.9 20.2–23.7ROR 22.3 · calibrated p 0.001 ✓ | 21.1 EB05 19.8 · IC025 +4.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.6–0.7) | Not in label — unassessed | serious PRR 17.9 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Anastrozole 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 (0 of 40 signal terms matched).
- NCT00066573 — Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cance (N=7576, PHASE3; 62 AE terms posted; arms: Exemestane; Anastrozole)
- NCT01272037 — Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients Wit (N=5018, PHASE3; 16 AE terms posted; arms: Chemo and Endocrine Therapy; Endocrine Therapy Alone)
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 3,444 | 2.6 2.5–2.6ROR 2.7 · calibrated p 0.726 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.7–0.8) | Labeled adverse reaction exact term | serious PRR 2.7 | NCT00066573: 1/3,761 (0.0%) on Anastrozole (serious AE) |
| Arthralgia (joint pain) | 3,229 | 4.5 4.4–4.7ROR 4.8 · calibrated p 0.252 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.3 (1.2–1.3) | Labeled adverse reaction exact term | serious PRR 4.5 | not reported in cached trials |
| Nausea | 2,781 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.995 | 2.0 EB05 2.0 · IC025 +1.0 vs other Aromatase Inhibitors: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00066573: 442/3,759 (11.8%) on Anastrozole |
| Alopecia (hair loss) | 2,596 | 7.7 7.4–8.0ROR 8.2 · calibrated p 0.062 | 7.6 EB05 7.3 · IC025 +2.9 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.2 (1.1–1.2) | Labeled adverse reaction exact term | serious PRR 7.6 | NCT00066573: 212/3,759 (5.6%) on Anastrozole |
| Diarrhoea (diarrhea) | 2,387 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.944 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.8–0.8) | Labeled adverse reaction exact term | serious PRR 2.2 | NCT00066573: 414/3,759 (11.0%) on Anastrozole |
| Pain | 1,844 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.807 | 1.7 EB05 1.7 · IC025 +0.7 vs other Aromatase Inhibitors: PRR 1.0 (0.9–1.0) | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00066573: 220/3,759 (5.9%) on Anastrozole |
| Headache | 1,806 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.765 | 1.7 EB05 1.6 · IC025 +0.7 vs other Aromatase Inhibitors: PRR 1.1 (1.0–1.1) | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00066573: 399/3,759 (10.6%) on Anastrozole |
| Asthenia (weakness) | 1,618 | 2.5 2.4–2.6ROR 2.5 · calibrated p 0.793 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 2.3 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,588 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.734 | 1.6 EB05 1.5 · IC025 +0.6 vs other Aromatase Inhibitors: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00066573: 652/3,759 (17.3%) on Anastrozole |
| Dizziness | 1,542 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.840 | 1.8 EB05 1.7 · IC025 +0.7 vs other Aromatase Inhibitors: PRR 1.0 (1.0–1.1) | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00066573: 504/3,759 (13.4%) on Anastrozole |
| Hot flush (hot flashes) | 1,426 | 11.1 10.5–11.6ROR 11.5 · calibrated p 0.020 ✓ | 10.9 EB05 10.4 · IC025 +3.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.5 (1.4–1.6) | Labeled adverse reaction exact term | serious PRR 11.3 | not reported in cached trials |
| Pain in extremity | 1,416 | 2.8 2.6–2.9ROR 2.8 · calibrated p 0.682 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.3 (1.2–1.3) | Not in label — unassessed | serious PRR 2.7 | not reported in cached trials |
| Malignant neoplasm progression | 1,387 | 7.9 7.5–8.3ROR 8.2 · calibrated p 0.062 | 7.8 EB05 7.5 · IC025 +2.9 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.5–0.5) | Reporting / coding artifact | serious PRR 6.7 | not reported in cached trials |
| Vomiting | 1,342 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.751 | 1.6 EB05 1.6 · IC025 +0.6 vs other Aromatase Inhibitors: PRR 0.8 (0.7–0.8) | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Malaise (feeling unwell) | 1,330 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.811 | 1.7 EB05 1.7 · IC025 +0.7 vs other Aromatase Inhibitors: PRR 0.9 (0.9–1.0) | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
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.
- Amaurosis fugax — n=224, PRR 152.4
- Pik3ca-activated mutation — n=50, PRR 104.0
- Pseudocirrhosis — n=49, PRR 100.8
- Breast cancer recurrent — n=370, PRR 76.4
- Pneumonia haemophilus — n=51, PRR 67.1
- Metastases to chest wall — n=36, PRR 66.6
- Metastases to thorax — n=26, PRR 65.4
- Metastases to breast — n=32, PRR 62.2
- Chest wall mass — n=24, PRR 58.5
- Metastases to the mediastinum — n=36, PRR 54.5
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 Anastrozole?
In FDA FAERS, the most frequently co-reported reaction terms for Anastrozole are fatigue, arthralgia, nausea, alopecia, diarrhoea, pain. 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 Anastrozole have an FDA boxed warning?
No. The FDA label retrieved for Anastrozole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Anastrozole 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 1d1d5818-1594-4f54-90a9-ae9a9afcdc67, effective 20260820; matched on
openfda.generic_name.exact:"ANASTROZOLE") - 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
ANASTROZOLE, 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.