BISMUTH SUBSALICYLATE

N/A

Manufactured by Lil' Drug Store Products, Inc.

17,164 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BISMUTH SUBSALICYLATE

BISMUTH SUBSALICYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lil' Drug Store Products, Inc.. The most commonly reported adverse reactions for BISMUTH SUBSALICYLATE include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, RENAL FAILURE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BISMUTH SUBSALICYLATE.

Top Adverse Reactions

CHRONIC KIDNEY DISEASE1,418 reports
ACUTE KIDNEY INJURY822 reports
RENAL FAILURE724 reports
DIARRHOEA711 reports
NAUSEA615 reports
END STAGE RENAL DISEASE462 reports
VOMITING400 reports
FATIGUE368 reports
RENAL INJURY327 reports
GASTROOESOPHAGEAL REFLUX DISEASE311 reports
DRUG INEFFECTIVE286 reports
DEPRESSION281 reports
CONSTIPATION259 reports
PAIN255 reports
OFF LABEL USE243 reports
ABDOMINAL PAIN242 reports
ABDOMINAL PAIN UPPER239 reports
DYSPNOEA239 reports
OSTEOPOROSIS239 reports
HEADACHE225 reports
ANXIETY222 reports
DIZZINESS213 reports
WEIGHT DECREASED187 reports
ASTHENIA185 reports
ABDOMINAL DISCOMFORT184 reports
FALL184 reports
DEATH182 reports
NEPHROGENIC ANAEMIA180 reports
ARTHRITIS174 reports
ABDOMINAL DISTENSION169 reports
DECREASED APPETITE167 reports
ARTHRALGIA162 reports
DYSPEPSIA161 reports
MALAISE157 reports
CONDITION AGGRAVATED146 reports
FAECES DISCOLOURED143 reports
COUGH142 reports
BACK PAIN139 reports
MULTIPLE FRACTURES132 reports
PRURITUS130 reports
PAIN IN EXTREMITY129 reports
BONE DISORDER125 reports
REBOUND ACID HYPERSECRETION124 reports
INSOMNIA117 reports
PYREXIA117 reports
TUBULOINTERSTITIAL NEPHRITIS116 reports
SOMNOLENCE115 reports
DIABETES MELLITUS113 reports
RASH111 reports
PNEUMONIA110 reports
CHEST PAIN107 reports
DRY MOUTH107 reports
ANAEMIA106 reports
FEELING ABNORMAL105 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE101 reports
HYPERTENSION99 reports
MUSCLE SPASMS99 reports
STRESS99 reports
DEHYDRATION97 reports
GENERAL PHYSICAL HEALTH DETERIORATION89 reports
DRUG HYPERSENSITIVITY88 reports
PRODUCT DOSE OMISSION ISSUE88 reports
SEPSIS87 reports
VITAMIN D DEFICIENCY87 reports
INTENTIONAL PRODUCT MISUSE86 reports
PRODUCT USE IN UNAPPROVED INDICATION86 reports
CATARACT85 reports
URINARY TRACT INFECTION85 reports
ASCITES84 reports
HYPERPARATHYROIDISM SECONDARY83 reports
GAIT DISTURBANCE81 reports
GASTROINTESTINAL DISORDER79 reports
HYPONATRAEMIA79 reports
SWELLING79 reports
OSTEOARTHRITIS78 reports
PULMONARY EMBOLISM77 reports
PERIPHERAL SWELLING76 reports
SLEEP DISORDER75 reports
THROMBOSIS74 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME71 reports
RENAL IMPAIRMENT71 reports
FOOT FRACTURE70 reports
NASOPHARYNGITIS70 reports
VENTRICULAR FIBRILLATION70 reports
APPENDICITIS69 reports
DRUG INTOLERANCE69 reports
FLATULENCE69 reports
PARAESTHESIA69 reports
OEDEMA PERIPHERAL66 reports
TREMOR66 reports
BLOOD CHOLESTEROL INCREASED65 reports
BLOOD PRESSURE INCREASED65 reports
APPENDICOLITH64 reports
CALCIUM DEFICIENCY64 reports
HYPOAESTHESIA64 reports
HYPOTENSION64 reports
CARDIOGENIC SHOCK63 reports
NEURALGIA63 reports
NEPHROPATHY62 reports
OSTEOPENIA62 reports

Report Outcomes

Out of 5,566 classified reports for BISMUTH SUBSALICYLATE:

Serious 71.6%Non-Serious 28.4%

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

Female3,060 (62.2%)
Male1,846 (37.5%)
Unknown12 (0.2%)

Reports by Age

Age 80129 reports
Age 60101 reports
Age 5691 reports
Age 6190 reports
Age 5481 reports
Age 6280 reports
Age 6680 reports
Age 6379 reports
Age 6579 reports
Age 5775 reports
Age 6472 reports
Age 6771 reports
Age 5570 reports
Age 7170 reports
Age 5968 reports
Age 5867 reports
Age 7765 reports
Age 5361 reports
Age 7061 reports
Age 7259 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 BISMUTH SUBSALICYLATE?

This profile reflects 17,164 FDA FAERS reports that mention BISMUTH SUBSALICYLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BISMUTH SUBSALICYLATE?

Frequently reported terms in FAERS include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, RENAL FAILURE, DIARRHOEA, NAUSEA, END STAGE RENAL DISEASE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BISMUTH SUBSALICYLATE?

Labeling and FAERS entries often list Lil' Drug Store Products, Inc. in connection with BISMUTH SUBSALICYLATE. 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.