Drug · FAERS side-effect profile with label screen
Rosuvastatin Calcium side effects: what 27,960 FDA adverse event reports show
Drug class
Not stated in label
Who reports
27,960 reports · 72% serious · 1,403 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
FDA label, Indications and Usage
What it is
Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.
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
Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 8Not in label — unassessed 28
What the badges mean
- 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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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). 1,177 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 |
|---|---|---|---|---|---|---|
| Plethysmography | 24 | 8,855.0 2,092.8–37,466.9ROR 8,862.6 · calibrated p 7e-16 ✓ | 441.2 EB05 312.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 56%) · 100% consumer | not reported in cached trials |
| Fractional exhaled nitric oxide increased | 88 | 782.4 579.8–1,055.7ROR 784.8 · calibrated p 2e-15 ✓ | 351.2 EB05 293.8 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 0% (drug 56%) | not reported in cached trials |
| Rhinitis perennial | 28 | 397.3 251.0–629.0ROR 397.7 · calibrated p 7e-12 ✓ | 219.9 EB05 159.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 56%) | not reported in cached trials |
| Malignant mediastinal neoplasm | 35 | 358.7 239.6–537.1ROR 359.2 · calibrated p 1e-11 ✓ | 213.6 EB05 160.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 56%) | not reported in cached trials |
| Rheumatoid factor negative | 55 | 338.2 245.9–465.3ROR 338.9 · calibrated p 9e-12 ✓ | 215.0 EB05 171.4 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Hyper ige syndrome | 32 | 291.5 193.6–438.9ROR 291.9 · calibrated p 7e-11 ✓ | 186.1 EB05 138.1 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=32 · ♀ 100% (drug 56%) | not reported in cached trials |
| Congenital hiatus hernia | 61 | 284.9 212.1–382.7ROR 285.5 · calibrated p 4e-11 ✓ | 193.4 EB05 156.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 0% (drug 56%) | not reported in cached trials |
| Reversible airways obstruction | 141 | 283.5 233.5–344.1ROR 284.9 · calibrated p 2e-11 ✓ | 199.6 EB05 173.4 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=141 | not reported in cached trials |
| Neurologic neglect syndrome | 152 | 279.7 232.2–337.0ROR 281.2 · calibrated p 3e-11 ✓ | 198.1 EB05 173.0 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 56%) · 94% clinician | not reported in cached trials |
| Gait spastic | 85 | 243.1 190.3–310.6ROR 243.8 · calibrated p 1e-10 ✓ | 175.9 EB05 146.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=85 · ♀ 0% (drug 56%) | not reported in cached trials |
| Blood mercury abnormal | 24 | 242.6 153.0–384.7ROR 242.8 · calibrated p 5e-10 ✓ | 159.8 EB05 113.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=24 · ♀ 0% (drug 56%) | not reported in cached trials |
| Spirometry abnormal | 139 | 232.6 192.3–281.3ROR 233.7 · calibrated p 1e-10 ✓ | 172.9 EB05 150.1 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=139 · ♀ 0% (drug 56%) | not reported in cached trials |
| Mite allergy | 150 | 230.6 192.0–276.9ROR 231.8 · calibrated p 1e-10 ✓ | 172.1 EB05 150.2 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=149 · ♀ 0% (drug 56%) | not reported in cached trials |
| Vital capacity decreased | 95 | 200.3 159.7–251.2ROR 201.0 · calibrated p 6e-10 ✓ | 152.9 EB05 128.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 100% (drug 56%) | not reported in cached trials |
| Carotid artery thrombosis | 153 | 163.6 137.4–194.9ROR 164.5 · calibrated p 3e-9 ✓ | 131.9 EB05 115.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=153 · ♀ 100% (drug 56%) · 94% clinician | not reported in cached trials |
| Needle fatigue | 80 | 158.7 124.7–202.0ROR 159.1 · calibrated p 5e-9 ✓ | 126.9 EB05 105.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=80 · ♀ 0% (drug 56%) | not reported in cached trials |
| Mycotic allergy | 140 | 149.3 124.5–179.0ROR 150.0 · calibrated p 6e-9 ✓ | 122.3 EB05 106.2 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=140 · ♀ 0% (drug 56%) | not reported in cached trials |
| Dust allergy | 147 | 134.8 113.1–160.6ROR 135.5 · calibrated p 1e-8 ✓ | 112.5 EB05 98.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=147 · ♀ 0% (drug 56%) | not reported in cached trials |
| Adjustment disorder | 184 | 123.0 105.3–143.7ROR 123.8 · calibrated p 3e-8 ✓ | 104.4 EB05 92.4 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=184 · ♀ 81% (drug 56%) · 90% clinician | not reported in cached trials |
| Sedation complication | 349 | 121.5 108.6–136.0ROR 123.1 · calibrated p 2e-8 ✓ | 103.9 EB05 95.1 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=349 · ♀ 100% (drug 56%) | not reported in cached trials |
| Mycobacterium test positive | 26 | 108.4 71.8–163.6ROR 108.5 · calibrated p 2e-7 ✓ | 88.7 EB05 63.6 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=26 · 100% clinician | not reported in cached trials |
| Human rhinovirus test positive | 43 | 97.6 71.0–134.2ROR 97.8 · calibrated p 3e-7 ✓ | 83.2 EB05 64.4 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=43 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Sputum culture positive | 95 | 97.5 78.7–120.7ROR 97.8 · calibrated p 2e-7 ✓ | 84.8 EB05 71.4 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=95 · ♀ 100% (drug 56%) | not reported in cached trials |
| Conjunctivitis allergic | 149 | 84.9 71.7–100.6ROR 85.4 · calibrated p 4e-7 ✓ | 75.5 EB05 65.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=149 · ♀ 0% (drug 56%) | not reported in cached trials |
| Relapsing-remitting multiple sclerosis | 80 | 76.5 60.8–96.2ROR 76.7 · calibrated p 1e-6 ✓ | 68.3 EB05 56.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=80 · ♀ 0% (drug 56%) | not reported in cached trials |
| Creatinine renal clearance decreased | 359 | 73.2 65.7–81.6ROR 74.2 · calibrated p 1e-6 ✓ | 66.5 EB05 60.9 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=357 · ♀ 100% (drug 56%) | not reported in cached trials |
| Viral test positive | 32 | 71.6 49.8–102.8ROR 71.6 · calibrated p 3e-6 ✓ | 63.0 EB05 46.7 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Pulmonary vasculitis | 46 | 71.3 52.7–96.5ROR 71.4 · calibrated p 2e-6 ✓ | 63.5 EB05 49.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 56%) | not reported in cached trials |
| Nasal oedema | 147 | 66.8 56.5–79.1ROR 67.2 · calibrated p 2e-6 ✓ | 60.9 EB05 53.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=147 · ♀ 100% (drug 56%) · 93% clinician | not reported in cached trials |
| Multiple drug therapy | 57 | 66.6 50.8–87.3ROR 66.7 · calibrated p 3e-6 ✓ | 60.0 EB05 48.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=57 · ♀ 100% (drug 56%) | not reported in cached trials |
| Lung diffusion test decreased | 32 | 65.8 45.8–94.4ROR 65.8 · calibrated p 4e-6 ✓ | 58.5 EB05 43.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 112 | 65.3 53.8–79.2ROR 65.5 · calibrated p 3e-6 ✓ | 59.5 EB05 50.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=111 · ♀ 28% (drug 56%) | not reported in cached trials |
| Bronchial secretion retention | 100 | 64.3 52.4–78.8ROR 64.5 · calibrated p 3e-6 ✓ | 58.6 EB05 49.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=100 · ♀ 100% (drug 56%) | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 71 | 62.8 49.3–80.0ROR 63.0 · calibrated p 4e-6 ✓ | 57.1 EB05 46.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=71 · ♀ 100% (drug 56%) | not reported in cached trials |
| Pneumonia haemophilus | 36 | 59.7 42.5–83.8ROR 59.8 · calibrated p 8e-6 ✓ | 53.8 EB05 40.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Intensive care unit acquired weakness | 28 | 59.2 40.3–87.0ROR 59.3 · calibrated p 9e-6 ✓ | 53.0 EB05 38.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Total lung capacity abnormal | 27 | 57.1 38.6–84.4ROR 57.1 · calibrated p 1e-5 ✓ | 51.3 EB05 37.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 56%) | not reported in cached trials |
| Respiratory gas exchange disorder | 26 | 56.4 37.9–84.1ROR 56.5 · calibrated p 1e-5 ✓ | 50.7 EB05 36.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 56%) · 100% consumer | not reported in cached trials |
| Endometrial disorder | 28 | 55.5 37.8–81.5ROR 55.6 · calibrated p 1e-5 ✓ | 50.1 EB05 36.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=28 | NCT00239681: 5/8,869 (0.1%) on Rosuvastatin Calcium (serious AE) |
| Blood pressure diastolic abnormal | 177 | 55.3 47.5–64.4ROR 55.7 · calibrated p 8e-6 ✓ | 51.3 EB05 45.2 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=177 · ♀ 77% (drug 56%) | 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 Rosuvastatin Calcium 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 (1 of 40 signal terms matched).
- NCT00239681 — JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events (N=17802, PHASE3; 894 AE terms posted; arms: PLACEBO; ROSUVASTATIN 20 MG)
- NCT00240331 — AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD) (N=2776, PHASE3; 939 AE terms posted; arms: Rosuvastatin 10mg; Placebo)
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 2,778 | 3.7 3.6–3.8ROR 4.0 · calibrated p 0.380 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | NCT00239681: 8/8,869 (0.1%) on Rosuvastatin Calcium; 6/8,864 (0.1%) control (serious AE) |
| Fatigue (tiredness) | 2,694 | 2.6 2.5–2.7ROR 2.8 · calibrated p 0.705 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | NCT00239681: 1/8,864 (0.0%) control (serious AE) |
| Drug ineffective (drug did not work) | 2,479 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.609 | 1.4 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.6 | not reported in cached trials |
| Pain | 2,470 | 3.0 2.9–3.1ROR 3.2 · calibrated p 0.562 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · ♀ 76% (drug 56%) | NCT00239681: 9/8,869 (0.1%) on Rosuvastatin Calcium; 7/8,864 (0.1%) control (serious AE) |
| Cough | 2,412 | 6.5 6.3–6.8ROR 7.0 · calibrated p 0.098 | 6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | NCT00239681: 2/8,864 (0.0%) control (serious AE) |
| Headache | 2,118 | 2.5 2.4–2.6ROR 2.7 · calibrated p 0.746 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | NCT00239681: 3/8,869 (0.0%) on Rosuvastatin Calcium; 3/8,864 (0.0%) control (serious AE) |
| Nausea | 1,988 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.920 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00239681: 1/8,869 (0.0%) on Rosuvastatin Calcium; 2/8,864 (0.0%) control (serious AE) |
| Pneumonia (lung infection) | 1,880 | 4.4 4.2–4.6ROR 4.6 · calibrated p 0.280 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 81% (drug 56%) | NCT00239681: 2/8,869 (0.0%) on Rosuvastatin Calcium; 3/8,864 (0.0%) control (serious AE) |
| Arthralgia (joint pain) | 1,748 | 3.2 3.0–3.3ROR 3.3 · calibrated p 0.533 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | NCT00239681: 7/8,869 (0.1%) on Rosuvastatin Calcium (serious AE) |
| Diarrhoea (diarrhea) | 1,737 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.994 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.1 | NCT00239681: 5/8,869 (0.1%) on Rosuvastatin Calcium; 8/8,864 (0.1%) control (serious AE) |
| Off label use (used outside approved label) | 1,667 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.620 | 1.4 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Asthma | 1,646 | 11.1 10.6–11.7ROR 11.8 · calibrated p 0.018 ✓ | 11.0 EB05 10.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | NCT00239681: 1/8,869 (0.0%) on Rosuvastatin Calcium (serious AE) |
| Malaise (feeling unwell) | 1,470 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.774 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · ♀ 76% (drug 56%) | NCT00239681: 1/8,864 (0.0%) control (serious AE) |
| Vomiting | 1,468 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.846 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · ♀ 80% (drug 56%) | NCT00239681: 2/8,869 (0.0%) on Rosuvastatin Calcium (serious AE) |
| Fall | 1,468 | 3.3 3.2–3.5ROR 3.4 · calibrated p 0.499 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | NCT00239681: 3/8,869 (0.0%) on Rosuvastatin Calcium; 3/8,864 (0.0%) 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.
- Plethysmography — n=24, PRR 8,855.0
- Fractional exhaled nitric oxide increased — n=88, PRR 782.4
- Rhinitis perennial — n=28, PRR 397.3
- Malignant mediastinal neoplasm — n=35, PRR 358.7
- Congenital hiatus hernia — n=61, PRR 284.9
- Reversible airways obstruction — n=141, PRR 283.5
- Neurologic neglect syndrome — n=152, PRR 279.7
- Gait spastic — n=85, PRR 243.1
- Mite allergy — n=150, PRR 230.6
- Vital capacity decreased — n=95, PRR 200.3
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 Rosuvastatin Calcium?
In FDA FAERS, the most frequently co-reported reaction terms for Rosuvastatin Calcium are dyspnoea, fatigue, pain, cough, headache, 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 Rosuvastatin Calcium have an FDA boxed warning?
No. The FDA label retrieved for Rosuvastatin Calcium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rosuvastatin Calcium 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 0ad5b7de-e97d-4989-91e4-edae73543896, effective 20241030; matched on
openfda.generic_name.exact:"ROSUVASTATIN") - 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, 1,217 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
ROSUVASTATIN, 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.