CINACALCET

N/A

Manufactured by Amneal Pharmaceuticals LLC

7,231 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CINACALCET

CINACALCET is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for CINACALCET include DEATH, OFF LABEL USE, DRUG INEFFECTIVE, HYPOCALCAEMIA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CINACALCET.

Top Adverse Reactions

DEATH435 reports
OFF LABEL USE378 reports
DRUG INEFFECTIVE348 reports
HYPOCALCAEMIA265 reports
NAUSEA217 reports
VOMITING190 reports
HYPERCALCAEMIA181 reports
DIARRHOEA159 reports
CALCIPHYLAXIS139 reports
ACUTE KIDNEY INJURY136 reports
DYSPNOEA106 reports
PARATHYROID TUMOUR BENIGN100 reports
DIZZINESS98 reports
SEPSIS97 reports
HYPOTENSION96 reports
RENAL FAILURE95 reports
CHRONIC KIDNEY DISEASE91 reports
BLOOD PARATHYROID HORMONE INCREASED90 reports
HEADACHE89 reports
END STAGE RENAL DISEASE86 reports
HOSPITALISATION86 reports
PNEUMONIA82 reports
FALL80 reports
PAIN80 reports
DECREASED APPETITE78 reports
HYPERTENSION78 reports
MATERNAL EXPOSURE DURING PREGNANCY78 reports
PYREXIA77 reports
CONDITION AGGRAVATED76 reports
FATIGUE73 reports
ANAEMIA70 reports
ASTHENIA70 reports
URINARY TRACT INFECTION68 reports
THERAPY NON RESPONDER67 reports
EXPOSURE DURING PREGNANCY65 reports
HUNGRY BONE SYNDROME65 reports
HYPERPARATHYROIDISM SECONDARY63 reports
HYPOMAGNESAEMIA62 reports
RENAL IMPAIRMENT61 reports
FOETAL EXPOSURE DURING PREGNANCY59 reports
HYPERPARATHYROIDISM59 reports
WEIGHT DECREASED58 reports
HYPERKALAEMIA57 reports
BACK PAIN54 reports
BLOOD CALCIUM INCREASED52 reports
CEREBROVASCULAR ACCIDENT48 reports
CONFUSIONAL STATE48 reports
GASTROINTESTINAL DISORDER48 reports
ABDOMINAL PAIN46 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION46 reports
CARDIAC ARREST45 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION45 reports
DRUG INTERACTION45 reports
MYOCARDIAL INFARCTION45 reports
PREMATURE BABY45 reports
ANXIETY44 reports
CARDIAC FAILURE44 reports
GASTROINTESTINAL HAEMORRHAGE43 reports
NEPHROLITHIASIS43 reports
PULMONARY EMBOLISM43 reports
THROMBOCYTOPENIA43 reports
TREATMENT NONCOMPLIANCE43 reports
ARTHRALGIA42 reports
COUGH42 reports
DISEASE PROGRESSION42 reports
LOSS OF CONSCIOUSNESS42 reports
PARATHYROID TUMOUR MALIGNANT42 reports
DEHYDRATION41 reports
CONSTIPATION40 reports
DRUG INTOLERANCE40 reports
PRODUCT DOSE OMISSION ISSUE40 reports
NEPHROGENIC ANAEMIA39 reports
HAEMOGLOBIN DECREASED38 reports
RENAL TRANSPLANT38 reports
BLOOD CREATININE INCREASED37 reports
CHRONIC KIDNEY DISEASE MINERAL AND BONE DISORDER37 reports
COVID 1937 reports
INFECTION37 reports
PREMATURE DELIVERY37 reports
TREATMENT FAILURE37 reports
ATRIAL FIBRILLATION36 reports
TOXICITY TO VARIOUS AGENTS36 reports
PARAESTHESIA35 reports
OEDEMA PERIPHERAL34 reports
ACUTE MYOCARDIAL INFARCTION33 reports
CHEST PAIN33 reports
ELECTROCARDIOGRAM QT PROLONGED33 reports
MALAISE33 reports
TACHYCARDIA33 reports
ABDOMINAL PAIN UPPER32 reports
CARDIOVASCULAR DISORDER32 reports
ERYTHEMA32 reports
HYPERPHOSPHATAEMIA32 reports
MUSCLE SPASMS32 reports
PERITONITIS32 reports
PRURITUS32 reports
BLOOD PRESSURE INCREASED29 reports
CARDIO RESPIRATORY ARREST29 reports
TREMOR29 reports
ABDOMINAL DISCOMFORT28 reports

Report Outcomes

Out of 4,468 classified reports for CINACALCET:

Serious 89.8%Non-Serious 10.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,167 (55.6%)
Male1,727 (44.3%)
Unknown4 (0.1%)

Reports by Age

Age 64102 reports
Age 6097 reports
Age 6187 reports
Age 7084 reports
Age 5680 reports
Age 6579 reports
Age 6778 reports
Age 6276 reports
Age 6876 reports
Age 6973 reports
Age 7871 reports
Age 7269 reports
Age 5368 reports
Age 5468 reports
Age 6667 reports
Age 5865 reports
Age 4964 reports
Age 6361 reports
Age 7361 reports
Age 7160 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CINACALCET?

This profile reflects 7,231 FDA FAERS reports that mention CINACALCET. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CINACALCET?

Frequently reported terms in FAERS include DEATH, OFF LABEL USE, DRUG INEFFECTIVE, HYPOCALCAEMIA, NAUSEA, VOMITING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CINACALCET?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with CINACALCET. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.