CALCITRIOL

N/A

Manufactured by Galderma Laboratories, L.P.

42,441 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CALCITRIOL

CALCITRIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Galderma Laboratories, L.P.. The most commonly reported adverse reactions for CALCITRIOL include NAUSEA, DIARRHOEA, CHRONIC KIDNEY DISEASE, OFF LABEL USE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CALCITRIOL.

Top Adverse Reactions

NAUSEA1,398 reports
DIARRHOEA1,127 reports
CHRONIC KIDNEY DISEASE1,101 reports
OFF LABEL USE1,063 reports
VOMITING1,043 reports
RENAL FAILURE1,042 reports
DYSPNOEA1,019 reports
FATIGUE968 reports
ACUTE KIDNEY INJURY945 reports
DEATH857 reports
DRUG HYPERSENSITIVITY825 reports
DRUG INEFFECTIVE747 reports
ASTHENIA722 reports
HEADACHE722 reports
ABDOMINAL PAIN721 reports
PAIN717 reports
END STAGE RENAL DISEASE699 reports
CONSTIPATION692 reports
ANAEMIA670 reports
HYPOCALCAEMIA662 reports
PYREXIA642 reports
PNEUMONIA635 reports
MALAISE543 reports
DIZZINESS531 reports
FALL521 reports
SEPSIS512 reports
HYPERTENSION506 reports
GENERAL PHYSICAL HEALTH DETERIORATION501 reports
WEIGHT DECREASED497 reports
RECALLED PRODUCT472 reports
PRURITUS467 reports
CONDITION AGGRAVATED449 reports
ARTHRALGIA441 reports
PAIN IN EXTREMITY429 reports
RENAL IMPAIRMENT429 reports
HYPERCALCAEMIA410 reports
DECREASED APPETITE394 reports
HYPOTENSION393 reports
BLOOD CREATININE INCREASED369 reports
COUGH367 reports
URINARY TRACT INFECTION367 reports
ABDOMINAL DISTENSION366 reports
NEPHROGENIC ANAEMIA362 reports
RASH362 reports
MUSCLE SPASMS354 reports
HYPONATRAEMIA341 reports
BACK PAIN340 reports
HAEMOGLOBIN DECREASED333 reports
PRODUCT DOSE OMISSION ISSUE333 reports
ANXIETY326 reports
HYPERPARATHYROIDISM SECONDARY326 reports
SOMNOLENCE323 reports
STRESS319 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME312 reports
OEDEMA PERIPHERAL311 reports
DRUG INTERACTION308 reports
ASCITES291 reports
CHEST PAIN284 reports
DEHYDRATION278 reports
CARDIOGENIC SHOCK264 reports
GAIT DISTURBANCE263 reports
DRY MOUTH262 reports
APPENDICITIS261 reports
ABDOMINAL PAIN UPPER259 reports
THROMBOSIS259 reports
PERIPHERAL SWELLING249 reports
PRODUCT USE IN UNAPPROVED INDICATION249 reports
DIABETES MELLITUS246 reports
APPENDICOLITH245 reports
BLOOD PRESSURE INCREASED245 reports
RENAL INJURY238 reports
DEPRESSION234 reports
ERYTHEMA230 reports
PARAESTHESIA230 reports
INSOMNIA223 reports
BLOOD CALCIUM DECREASED222 reports
SWELLING221 reports
FEELING ABNORMAL215 reports
VENTRICULAR FIBRILLATION215 reports
DRUG INTOLERANCE212 reports
WEIGHT INCREASED211 reports
ABDOMINAL DISCOMFORT208 reports
TREMOR208 reports
BLOOD PHOSPHORUS INCREASED207 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE205 reports
PULMONARY EMBOLISM205 reports
CONFUSIONAL STATE203 reports
BLOOD GLUCOSE INCREASED201 reports
CARDIAC ARREST200 reports
MYALGIA199 reports
HYPOAESTHESIA198 reports
GOUT194 reports
HOSPITALISATION191 reports
RENAL DISORDER187 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION186 reports
PLATELET COUNT DECREASED185 reports
CARDIAC FAILURE CONGESTIVE184 reports
COVID 19184 reports
NEPHROLITHIASIS180 reports
LOSS OF CONSCIOUSNESS179 reports

Report Outcomes

Out of 19,429 classified reports for CALCITRIOL:

Serious 77.4%Non-Serious 22.6%

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

Female9,985 (55.4%)
Male8,004 (44.4%)
Unknown23 (0.1%)

Reports by Age

Age 80479 reports
Age 65386 reports
Age 71341 reports
Age 64338 reports
Age 66336 reports
Age 63331 reports
Age 69327 reports
Age 74312 reports
Age 67307 reports
Age 68306 reports
Age 70300 reports
Age 62297 reports
Age 72293 reports
Age 59282 reports
Age 77276 reports
Age 75273 reports
Age 73270 reports
Age 60268 reports
Age 76261 reports
Age 58257 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 CALCITRIOL?

This profile reflects 42,441 FDA FAERS reports that mention CALCITRIOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CALCITRIOL?

Frequently reported terms in FAERS include NAUSEA, DIARRHOEA, CHRONIC KIDNEY DISEASE, OFF LABEL USE, VOMITING, RENAL FAILURE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CALCITRIOL?

Labeling and FAERS entries often list Galderma Laboratories, L.P. in connection with CALCITRIOL. 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.