Drug · FAERS side-effect profile with label screen
Cinacalcet side effects: what 4,673 FDA adverse event reports show
Drug class
Calcium-sensing receptor agonist
FDA label, Indications wording
Who reports
4,673 reports · 89% serious · 793 with death outcome · 56% 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
Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 5Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 24
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.
- 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. 138 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 |
|---|---|---|---|---|---|---|
| Hypercalcaemia | 189 | 69.8 60.6–80.3ROR 72.7 · χ² 12,557 / p <1e-300 | 68.3 EB05 60.5 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 46.1 · 92% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 273 | 65.8 58.6–73.9ROR 69.8 · χ² 17,121 / p <1e-300 | 64.6 EB05 58.4 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 40.2 · 99% clinician | no trial data cached |
| End stage renal disease | 87 | 21.3 17.3–26.2ROR 21.7 · χ² 1,655 / p <1e-300 | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Hypomagnesaemia | 64 | 20.8 16.3–26.5ROR 21.1 · χ² 1,181 / p 5e-259 | 20.6 EB05 16.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · 97% clinician | no trial data cached |
| Vitamin d deficiency | 28 | 12.9 8.9–18.7ROR 13.0 · χ² 295 / p 2e-66 | 12.4 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 96% clinician | no trial data cached |
| Peritonitis bacterial | 27 | 12.1 8.3–17.6ROR 12.1 · χ² 262 / p 3e-59 | 11.4 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 93% clinician | no trial data cached |
| Premature delivery | 38 | 10.7 7.8–14.7ROR 10.8 · χ² 323 / p 2e-72 | 10.2 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 100% (drug 56%) · 95% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 58 | 7.5 5.8–9.6ROR 7.5 · χ² 318 / p 2e-71 | 7.1 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 94% clinician | no trial data cached |
| Dialysis | 23 | 7.3 4.8–10.9ROR 7.3 · χ² 118 / p 9e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.3 | no trial data cached |
| Therapy non-responder | 71 | 7.2 5.7–9.0ROR 7.2 · χ² 370 / p 1e-82 | 6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 97% clinician | no trial data cached |
| Fluid overload | 23 | 7.0 4.7–10.5ROR 7.0 · χ² 112 / p 2e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Peritonitis | 32 | 6.9 4.9–9.8ROR 7.0 · χ² 157 / p 3e-36 | 6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 91% clinician | no trial data cached |
| Drug effective for unapproved indication | 45 | 6.9 5.2–9.3ROR 7.0 · χ² 222 / p 2e-50 | 6.5 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=32 · 100% clinician | no trial data cached |
| Myoclonus | 18 | 6.8 4.3–10.8ROR 6.8 · χ² 83 / p 4e-20 | 5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Premature baby | 45 | 6.7 5.0–9.0ROR 6.7 · χ² 212 / p 2e-48 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 17% (drug 56%) · 93% clinician | no trial data cached |
| Blood calcium decreased | 16 | 6.4 3.9–10.4ROR 6.4 · χ² 67 / p 1e-16 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.5 | no trial data cached |
| Gastroenteritis | 20 | 6.2 4.0–9.5ROR 6.2 · χ² 81 / p 9e-20 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Fracture | 24 | 5.7 3.8–8.5ROR 5.7 · χ² 88 / p 3e-21 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Cardiovascular disorder | 32 | 5.6 4.0–7.9ROR 5.6 · χ² 117 / p 2e-27 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 100% clinician | no trial data cached |
| Ileus | 15 | 5.5 3.3–9.1ROR 5.5 · χ² 50 / p 6e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Chronic kidney disease | 92 | 5.4 4.4–6.6ROR 5.5 · χ² 325 / p 5e-73 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.5 | no trial data cached |
| Malnutrition | 13 | 5.3 3.1–9.0ROR 5.3 · χ² 41 / p 9e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Spinal fracture | 23 | 5.2 3.4–7.8ROR 5.2 · χ² 73 / p 5e-18 | 4.7 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 100% clinician | no trial data cached |
| Therapy partial responder | 17 | 5.1 3.2–8.1ROR 5.1 · χ² 51 / p 4e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Acute myocardial infarction | 33 | 5.0 3.6–7.0ROR 5.0 · χ² 102 / p 3e-24 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 97% clinician | no trial data cached |
| Gastric ulcer | 21 | 5.0 3.2–7.6ROR 5.0 · χ² 62 / p 1e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 95% clinician | no trial data cached |
| Hypertensive crisis | 12 | 4.8 2.7–8.5ROR 4.8 · χ² 33 / p 6e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Nephropathy | 10 | 4.8 2.6–8.9ROR 4.8 · χ² 26 / p 2e-7 | 4.0 EB05 2.4 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Exposure during pregnancy | 66 | 4.8 3.7–6.1ROR 4.8 · χ² 193 / p 4e-44 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · ♀ 100% (drug 56%) · 98% clinician | no trial data cached |
| Device related infection | 16 | 4.7 2.9–7.6ROR 4.7 · χ² 42 / p 4e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Renal tubular necrosis | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 150 | 4.4 3.8–5.2ROR 4.5 · χ² 396 / p 2e-88 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Nephrolithiasis (kidney stones) | 45 | 4.4 3.3–5.9ROR 4.4 · χ² 116 / p 3e-27 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Myocardial ischaemia | 11 | 4.3 2.4–7.8ROR 4.3 · χ² 25 / p 3e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Multiple organ dysfunction syndrome | 26 | 4.2 2.8–6.1ROR 4.2 · χ² 60 / p 5e-15 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 96% clinician | no trial data cached |
| Ataxia | 11 | 4.1 2.3–7.5ROR 4.2 · χ² 23 / p 7e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Maternal exposure during pregnancy | 81 | 4.1 3.3–5.1ROR 4.2 · χ² 189 / p 3e-43 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · ♀ 100% (drug 56%) · 96% clinician | no trial data cached |
| Osteopenia | 14 | 4.1 2.4–7.0ROR 4.1 · χ² 30 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Electrocardiogram qt prolonged | 33 | 4.1 2.9–5.8ROR 4.1 · χ² 75 / p 3e-18 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 · ♀ 31% (drug 56%) · 97% clinician | no trial data cached |
| Bone density decreased | 29 | 4.1 2.9–5.9ROR 4.1 · χ² 65 / p 3e-16 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 3.3 · 93% clinician | 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 | 436 | 2.3 2.1–2.5ROR 2.4 · χ² 322 / p 3e-72 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.5 | no trial data cached |
| Hypocalcaemia (low calcium) | 273 | 65.8 58.6–73.9ROR 69.8 · χ² 17,121 / p <1e-300 | 64.6 EB05 58.4 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 40.2 · 99% clinician | no trial data cached |
| Hypercalcaemia | 189 | 69.8 60.6–80.3ROR 72.7 · χ² 12,557 / p <1e-300 | 68.3 EB05 60.5 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 46.1 · 92% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 150 | 4.4 3.8–5.2ROR 4.5 · χ² 396 / p 2e-88 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Sepsis (blood infection) | 100 | 4.0 3.3–4.9ROR 4.1 · χ² 225 / p 4e-51 | 4.0 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 93% clinician | no trial data cached |
| Renal failure (kidney failure) | 99 | 3.3 2.7–4.0ROR 3.4 · χ² 159 / p 9e-37 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 | no trial data cached |
| Chronic kidney disease | 92 | 5.4 4.4–6.6ROR 5.5 · χ² 325 / p 5e-73 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.5 | no trial data cached |
| Hospitalisation | 91 | 2.7 2.2–3.3ROR 2.7 · χ² 95 / p 1e-22 | 2.7 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| End stage renal disease | 87 | 21.3 17.3–26.2ROR 21.7 · χ² 1,655 / p <1e-300 | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Maternal exposure during pregnancy | 81 | 4.1 3.3–5.1ROR 4.2 · χ² 189 / p 3e-43 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · ♀ 100% (drug 56%) · 96% clinician | no trial data cached |
| Therapy non-responder | 71 | 7.2 5.7–9.0ROR 7.2 · χ² 370 / p 1e-82 | 6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 97% clinician | no trial data cached |
| Exposure during pregnancy | 66 | 4.8 3.7–6.1ROR 4.8 · χ² 193 / p 4e-44 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · ♀ 100% (drug 56%) · 98% clinician | no trial data cached |
| Renal impairment | 64 | 3.4 2.7–4.4ROR 3.5 · χ² 108 / p 1e-25 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 94% clinician | no trial data cached |
| Hypomagnesaemia | 64 | 20.8 16.3–26.5ROR 21.1 · χ² 1,181 / p 5e-259 | 20.6 EB05 16.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · 97% clinician | no trial data cached |
| Foetal exposure during pregnancy | 59 | 3.3 2.5–4.2ROR 3.3 · χ² 90 / p 1e-21 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · ♀ 34% (drug 56%) · 97% clinician | 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.
- End stage renal disease — n=87, PRR 21.3
- Hypomagnesaemia — n=64, PRR 20.8
- Vitamin d deficiency — n=28, PRR 12.9
- Peritonitis bacterial — n=27, PRR 12.1
- Premature delivery — n=38, PRR 10.7
- Fluid overload — n=23, PRR 7.0
- Peritonitis — n=32, PRR 6.9
- Premature baby — n=45, PRR 6.7
- Gastroenteritis — n=20, PRR 6.2
- Spinal fracture — n=23, PRR 5.2
✓ 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 hypocalcaemia, hypercalcaemia, acute kidney injury, sepsis, renal failure, chronic kidney disease. 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, 178 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
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.