CALCITRIOL CAPSULES 0.5 MCG

N/A

Manufactured by Strides Pharma Science Limited

42,159 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CALCITRIOL CAPSULES 0.5 MCG

CALCITRIOL CAPSULES 0.5 MCG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Strides Pharma Science Limited. The most commonly reported adverse reactions for CALCITRIOL CAPSULES 0.5 MCG include NAUSEA, DIARRHOEA, CHRONIC KIDNEY DISEASE, OFF LABEL USE, RENAL FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CALCITRIOL CAPSULES 0.5 MCG.

Top Adverse Reactions

NAUSEA1,383 reports
DIARRHOEA1,109 reports
CHRONIC KIDNEY DISEASE1,099 reports
OFF LABEL USE1,060 reports
RENAL FAILURE1,041 reports
VOMITING1,040 reports
DYSPNOEA1,013 reports
FATIGUE955 reports
ACUTE KIDNEY INJURY943 reports
DEATH855 reports
DRUG HYPERSENSITIVITY824 reports
ABDOMINAL PAIN719 reports
ASTHENIA719 reports
DRUG INEFFECTIVE717 reports
HEADACHE706 reports
PAIN704 reports
END STAGE RENAL DISEASE699 reports
CONSTIPATION691 reports
ANAEMIA668 reports
HYPOCALCAEMIA662 reports
PYREXIA639 reports
PNEUMONIA631 reports
MALAISE537 reports
DIZZINESS527 reports
FALL519 reports
SEPSIS512 reports
HYPERTENSION505 reports
GENERAL PHYSICAL HEALTH DETERIORATION501 reports
WEIGHT DECREASED493 reports
RECALLED PRODUCT472 reports
PRURITUS451 reports
CONDITION AGGRAVATED448 reports
ARTHRALGIA430 reports
RENAL IMPAIRMENT428 reports
PAIN IN EXTREMITY420 reports
HYPERCALCAEMIA410 reports
DECREASED APPETITE394 reports
HYPOTENSION393 reports
BLOOD CREATININE INCREASED369 reports
URINARY TRACT INFECTION367 reports
ABDOMINAL DISTENSION365 reports
COUGH365 reports
NEPHROGENIC ANAEMIA362 reports
MUSCLE SPASMS352 reports
RASH352 reports
HYPONATRAEMIA341 reports
BACK PAIN339 reports
HAEMOGLOBIN DECREASED333 reports
PRODUCT DOSE OMISSION ISSUE331 reports
HYPERPARATHYROIDISM SECONDARY326 reports
ANXIETY324 reports
SOMNOLENCE321 reports
STRESS318 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME311 reports
OEDEMA PERIPHERAL311 reports
DRUG INTERACTION307 reports
ASCITES291 reports
CHEST PAIN281 reports
DEHYDRATION278 reports
CARDIOGENIC SHOCK264 reports
GAIT DISTURBANCE262 reports
APPENDICITIS261 reports
DRY MOUTH261 reports
THROMBOSIS258 reports
ABDOMINAL PAIN UPPER255 reports
PRODUCT USE IN UNAPPROVED INDICATION248 reports
PERIPHERAL SWELLING247 reports
APPENDICOLITH245 reports
DIABETES MELLITUS245 reports
BLOOD PRESSURE INCREASED244 reports
RENAL INJURY238 reports
DEPRESSION231 reports
PARAESTHESIA225 reports
BLOOD CALCIUM DECREASED222 reports
ERYTHEMA222 reports
INSOMNIA221 reports
SWELLING221 reports
VENTRICULAR FIBRILLATION215 reports
DRUG INTOLERANCE212 reports
FEELING ABNORMAL210 reports
WEIGHT INCREASED209 reports
TREMOR208 reports
BLOOD PHOSPHORUS INCREASED207 reports
ABDOMINAL DISCOMFORT206 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE203 reports
CONFUSIONAL STATE203 reports
PULMONARY EMBOLISM203 reports
BLOOD GLUCOSE INCREASED199 reports
CARDIAC ARREST199 reports
HYPOAESTHESIA196 reports
GOUT194 reports
MYALGIA194 reports
HOSPITALISATION190 reports
RENAL DISORDER187 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION186 reports
COVID 19184 reports
PLATELET COUNT DECREASED184 reports
CARDIAC FAILURE CONGESTIVE181 reports
NEPHROLITHIASIS180 reports
HYPERKALAEMIA178 reports

Report Outcomes

Out of 19,197 classified reports for CALCITRIOL CAPSULES 0.5 MCG:

Serious 77.9%Non-Serious 22.1%

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

Female9,855 (55.4%)
Male7,904 (44.5%)
Unknown22 (0.1%)

Reports by Age

Age 80479 reports
Age 65383 reports
Age 71340 reports
Age 64333 reports
Age 66333 reports
Age 63327 reports
Age 69325 reports
Age 74310 reports
Age 67304 reports
Age 68304 reports
Age 70299 reports
Age 62294 reports
Age 72291 reports
Age 59279 reports
Age 77276 reports
Age 75271 reports
Age 73263 reports
Age 76261 reports
Age 60258 reports
Age 58252 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 CAPSULES 0.5 MCG?

This profile reflects 42,159 FDA FAERS reports that mention CALCITRIOL CAPSULES 0.5 MCG. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CALCITRIOL CAPSULES 0.5 MCG?

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

Who manufactures CALCITRIOL CAPSULES 0.5 MCG?

Labeling and FAERS entries often list Strides Pharma Science Limited in connection with CALCITRIOL CAPSULES 0.5 MCG. 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.