Drug · FAERS side-effect profile with label screen
Cinacalcet Hydrochloride side effects: what 46,327 FDA adverse event reports show
Drug class
Calcium-sensing receptor agonist
FDA label, Indications wording
Who reports
46,327 reports · 37% serious · 2,518 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cinacalcet hydrochloride is a calcium-sensing receptor agonist indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis. Hypercalcemia in adult patients with Parathyroid Carcinoma (PC).
FDA label, Indications and Usage
What it is
Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet, a positive modulator of the calcium sensing receptor.
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 11Reporting / coding artifact 6Lab value / disease marker 6Not in label — unassessed 17
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,010 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 |
|---|---|---|---|---|---|---|
| Blood parathyroid hormone abnormal | 342 | 527.4 451.0–616.6ROR 531.3 · χ² 82,054 / p <1e-300 | 238.9 EB05 218.4 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=55 | NCT00345839: 1/1,923 (0.1%) control (serious AE) |
| Parathyroid hyperplasia | 17 | 194.3 109.9–343.3ROR 194.3 · χ² 2,143 / p <1e-300 | 118.0 EB05 78.0 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Hungry bone syndrome | 54 | 191.0 138.9–262.7ROR 191.2 · χ² 7,011 / p <1e-300 | 128.0 EB05 101.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=54 · 100% clinician | not reported in cached trials |
| Unevaluable investigation | 48 | 181.3 129.6–253.5ROR 181.5 · χ² 5,990 / p <1e-300 | 122.9 EB05 96.4 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=47 | not reported in cached trials |
| Parathyroid tumour malignant | 36 | 174.4 118.6–256.3ROR 174.5 · χ² 4,337 / p <1e-300 | 117.9 EB05 89.0 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=36 · 100% clinician | not reported in cached trials |
| Hyperparathyroidism tertiary | 19 | 151.2 89.9–254.4ROR 151.3 · χ² 2,006 / p <1e-300 | 101.8 EB05 68.9 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | NCT00345839: 2/1,938 (0.1%) on Cinacalcet; 8/1,923 (0.4%) control (serious AE) |
| Brown tumour | 10 | 111.4 55.7–222.8ROR 111.4 · χ² 789 / p 6e-174 | 76.7 EB05 44.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | NCT01896232: 1/338 (0.3%) on Cinacalcet (serious AE) |
| Blood parathyroid hormone increased | 544 | 103.6 94.4–113.6ROR 104.8 · χ² 44,758 / p <1e-300 | 84.0 EB05 78.2 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=192 | NCT00345839: 1/1,923 (0.1%) control (serious AE) |
| Laboratory test abnormal | 4,222 | 75.7 73.3–78.1ROR 83.1 · χ² 266,197 / p <1e-300 | 64.8 EB05 63.2 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | not reported in cached trials |
| Arteriovenous fistula occlusion | 25 | 74.8 49.0–114.2ROR 74.8 · χ² 1,496 / p <1e-300 | 61.3 EB05 43.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 92% (drug 54%) | NCT00345839: 13/1,938 (0.7%) on Cinacalcet; 8/1,923 (0.4%) control (serious AE) |
| Parathyroidectomy | 63 | 69.0 52.9–89.9ROR 69.1 · χ² 3,596 / p <1e-300 | 58.9 EB05 47.6 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications | serious n=62 | not reported in cached trials |
| Blood parathyroid hormone decreased | 189 | 65.6 56.4–76.5ROR 65.9 · χ² 10,432 / p <1e-300 | 57.0 EB05 50.5 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=28 | NCT00345839: 1/1,923 (0.1%) control (serious AE) |
| Parathyroid tumour benign | 88 | 60.6 48.5–75.7ROR 60.7 · χ² 4,489 / p <1e-300 | 52.9 EB05 44.3 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=88 · 95% clinician | NCT00345839: 1/1,938 (0.1%) on Cinacalcet; 6/1,923 (0.3%) control (serious AE) |
| Living in residential institution | 214 | 58.0 50.3–66.9ROR 58.3 · χ² 10,559 / p <1e-300 | 51.2 EB05 45.7 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=25 | not reported in cached trials |
| Blood phosphorus abnormal | 41 | 43.7 31.7–60.2ROR 43.7 · χ² 1,520 / p <1e-300 | 39.2 EB05 30.1 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Skin fibrosis | 40 | 40.9 29.6–56.5ROR 40.9 · χ² 1,389 / p <1e-300 | 36.9 EB05 28.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Blood calcium abnormal | 133 | 39.5 33.1–47.1ROR 39.6 · χ² 4,548 / p <1e-300 | 36.2 EB05 31.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=46 | NCT00345839: 1/1,938 (0.1%) on Cinacalcet (serious AE) |
| Parathyroid gland enlargement | 11 | 37.1 20.1–68.7ROR 37.1 · χ² 324 / p 8e-73 | 32.6 EB05 19.4 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | NCT00345839: 2/1,938 (0.1%) on Cinacalcet; 1/1,923 (0.1%) control (serious AE) |
| Chronic kidney disease-mineral and bone disorder | 75 | 33.9 26.8–42.8ROR 33.9 · χ² 2,193 / p <1e-300 | 31.3 EB05 25.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=75 | not reported in cached trials |
| Enteral nutrition | 38 | 32.7 23.5–45.4ROR 32.7 · χ² 1,058 / p 2e-232 | 30.1 EB05 22.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Gastrostomy tube insertion | 13 | 32.5 18.5–57.2ROR 32.6 · χ² 342 / p 1e-76 | 29.2 EB05 18.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Calciphylaxis | 118 | 31.2 25.9–37.5ROR 31.2 · χ² 3,191 / p <1e-300 | 29.1 EB05 24.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=115 · 92% clinician | NCT00345839: 3/1,938 (0.2%) on Cinacalcet; 13/1,923 (0.7%) control (serious AE) |
| Hyperparathyroidism secondary | 158 | 30.1 25.6–35.3ROR 30.2 · χ² 4,134 / p <1e-300 | 28.2 EB05 24.7 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=157 | NCT00345839: 23/1,938 (1.2%) on Cinacalcet; 86/1,923 (4.5%) control (serious AE) |
| Transplant | 145 | 29.4 24.8–34.7ROR 29.5 · χ² 3,702 / p <1e-300 | 27.5 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=145 | NCT00345839: 6/1,938 (0.3%) on Cinacalcet; 3/1,923 (0.2%) control (serious AE) |
| Rehabilitation therapy | 203 | 25.1 21.8–28.9ROR 25.2 · χ² 4,424 / p <1e-300 | 23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=37 | not reported in cached trials |
| Drug dose omission | 8,738 | 24.8 24.4–25.3ROR 30.4 · χ² 190,916 / p <1e-300 | 23.6 EB05 23.2 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | not reported in cached trials |
| Parathyroid disorder | 42 | 24.8 18.2–33.9ROR 24.8 · χ² 887 / p 3e-195 | 23.3 EB05 18.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=24 | NCT00345839: 1/1,923 (0.1%) control (serious AE) |
| Arteriovenous fistula thrombosis | 18 | 24.6 15.3–39.5ROR 24.6 · χ² 364 / p 2e-81 | 22.8 EB05 15.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=18 | NCT00345839: 49/1,938 (2.5%) on Cinacalcet; 43/1,923 (2.2%) control (serious AE) |
| Blue toe syndrome | 20 | 24.5 15.6–38.4ROR 24.5 · χ² 405 / p 2e-90 | 22.8 EB05 15.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Arteriovenous fistula site complication | 31 | 24.4 17.0–35.0ROR 24.4 · χ² 638 / p 5e-141 | 22.9 EB05 16.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=26 · 90% clinician | NCT00345839: 36/1,938 (1.9%) on Cinacalcet; 44/1,923 (2.3%) control (serious AE) |
| Blood phosphorus increased | 136 | 23.7 20.0–28.2ROR 23.8 · χ² 2,790 / p <1e-300 | 22.5 EB05 19.5 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=29 | not reported in cached trials |
| Hyperparathyroidism primary | 18 | 23.3 14.5–37.5ROR 23.3 · χ² 344 / p 3e-77 | 21.7 EB05 14.4 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=18 | NCT00345839: 23/1,938 (1.2%) on Cinacalcet; 86/1,923 (4.5%) control (serious AE) |
| Parathyroid tumour | 13 | 22.4 12.8–39.0ROR 22.4 · χ² 233 / p 8e-53 | 20.6 EB05 12.4 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | NCT00345839: 1/1,938 (0.1%) on Cinacalcet; 6/1,923 (0.3%) control (serious AE) |
| Nephrogenic systemic fibrosis | 140 | 21.7 18.3–25.7ROR 21.7 · χ² 2,611 / p <1e-300 | 20.6 EB05 17.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=139 | not reported in cached trials |
| Hospitalisation | 6,929 | 21.5 21.1–22.0ROR 25.1 · χ² 130,308 / p <1e-300 | 20.6 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 33.1 | not reported in cached trials |
| Fistula repair | 11 | 20.2 11.0–36.9ROR 20.2 · χ² 174 / p 5e-40 | 18.3 EB05 10.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Renal transplant | 143 | 18.6 15.8–22.0ROR 18.7 · χ² 2,274 / p <1e-300 | 17.9 EB05 15.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=139 | not reported in cached trials |
| Nephrogenic anaemia | 182 | 18.3 15.8–21.2ROR 18.4 · χ² 2,843 / p <1e-300 | 17.6 EB05 15.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=182 | NCT00345839: 1/1,923 (0.1%) control (serious AE) |
| Extremity contracture | 24 | 17.6 11.7–26.4ROR 17.6 · χ² 345 / p 3e-77 | 16.6 EB05 11.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Shunt stenosis | 10 | 16.7 8.9–31.4ROR 16.7 · χ² 127 / p 7e-30 | 14.6 EB05 7.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT00345839: 6/1,938 (0.3%) on Cinacalcet; 4/1,923 (0.2%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Cinacalcet 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 (19 of 40 signal terms matched).
- NCT00345839 — E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (N=3883, PHASE3; 1314 AE terms posted; arms: Placebo; Cinacalcet)
- NCT01896232 — Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet (N=683, PHASE3; 205 AE terms posted; arms: Cinacalcet; Etelcalcetide)
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 |
|---|---|---|---|---|---|---|
| Drug dose omission | 8,738 | 24.8 24.4–25.3ROR 30.4 · χ² 190,916 / p <1e-300 | 23.6 EB05 23.2 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | not reported in cached trials |
| Hospitalisation | 6,929 | 21.5 21.1–22.0ROR 25.1 · χ² 130,308 / p <1e-300 | 20.6 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 33.1 | not reported in cached trials |
| Laboratory test abnormal | 4,222 | 75.7 73.3–78.1ROR 83.1 · χ² 266,197 / p <1e-300 | 64.8 EB05 63.2 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | not reported in cached trials |
| Off label use (used outside approved label) | 2,500 | 1.3 1.3–1.4ROR 1.3 · χ² 185 / p 2e-42 | 1.3 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 0.5 · 76% consumer | not reported in cached trials |
| Nausea | 2,284 | 1.3 1.3–1.4ROR 1.3 · χ² 175 / p 4e-40 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 0.9 | NCT00345839: 20/1,938 (1.0%) on Cinacalcet; 16/1,923 (0.8%) control (serious AE) |
| Intentional product misuse | 2,084 | 11.1 10.6–11.6ROR 11.6 · χ² 18,764 / p <1e-300 | 10.9 EB05 10.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Death | 1,832 | 1.0 0.9–1.0ROR 1.0 · χ² 3 / p 0.050 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.5 | NCT00345839: 38/1,938 (2.0%) on Cinacalcet; 38/1,923 (2.0%) control (serious AE) |
| Malaise (feeling unwell) | 1,563 | 1.6 1.5–1.7ROR 1.6 · χ² 369 / p 2e-82 | 1.6 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.1 | NCT00345839: 4/1,938 (0.2%) on Cinacalcet; 4/1,923 (0.2%) control (serious AE) |
| Vomiting | 1,546 | 1.5 1.4–1.6ROR 1.5 · χ² 257 / p 4e-58 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 0.9 | NCT00345839: 33/1,938 (1.7%) on Cinacalcet; 23/1,923 (1.2%) control (serious AE) |
| Adverse drug reaction | 1,460 | 7.5 7.1–7.9ROR 7.7 · χ² 8,108 / p <1e-300 | 7.4 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | NCT00345839: 1/1,938 (0.1%) on Cinacalcet; 1/1,923 (0.1%) control (serious AE) |
| Diarrhoea (diarrhea) | 1,134 | 0.8 0.8–0.8ROR 0.8 · χ² 60 / p 5e-15 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.6 | NCT00345839: 32/1,938 (1.7%) on Cinacalcet; 24/1,923 (1.2%) control (serious AE) |
| Decreased appetite (loss of appetite) | 828 | 1.6 1.5–1.7ROR 1.6 · χ² 198 / p 4e-45 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 0.7 | NCT00345839: 3/1,938 (0.2%) on Cinacalcet (serious AE) |
| Abdominal discomfort | 775 | 2.1 2.0–2.3ROR 2.1 · χ² 449 / p 6e-100 | 2.1 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.1 | NCT00345839: 1/1,938 (0.1%) on Cinacalcet; 3/1,923 (0.2%) control (serious AE) |
| Muscle spasms | 600 | 1.5 1.4–1.6ROR 1.5 · χ² 94 / p 2e-22 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 0.8 | NCT00345839: 2/1,938 (0.1%) on Cinacalcet; 3/1,923 (0.2%) control (serious AE) |
| Hypotension (low blood pressure) | 577 | 1.3 1.2–1.4ROR 1.3 · χ² 41 / p 7e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00345839: 10/1,938 (0.5%) on Cinacalcet; 2/1,923 (0.1%) 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.
- Hungry bone syndrome — n=54, PRR 191.0
- Arteriovenous fistula occlusion — n=25, PRR 74.8 (also seen in trial arm)
- Skin fibrosis — n=40, PRR 40.9
- Chronic kidney disease-mineral and bone disorder — n=75, PRR 33.9
- Enteral nutrition — n=38, PRR 32.7
- Calciphylaxis — n=118, PRR 31.2 (also seen in trial arm)
- Transplant — n=145, PRR 29.4 (also seen in trial arm)
- Blue toe syndrome — n=20, PRR 24.5
- Nephrogenic systemic fibrosis — n=140, PRR 21.7
- Renal transplant — n=143, PRR 18.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Cinacalcet ↔ Hypocalcaemia.
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 Cinacalcet?
In FDA FAERS, the most frequently co-reported reaction terms for Cinacalcet are nausea, malaise, vomiting, diarrhoea, decreased appetite, abdominal discomfort. 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 Cinacalcet have an FDA boxed warning?
No. The FDA label retrieved for Cinacalcet has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cinacalcet 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 04a978cb-d57b-4f1e-ba14-316b6f9abe33, effective 20200414; matched on
openfda.generic_name.exact:"CINACALCET") - 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, 1,050 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
CINACALCET, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. 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.