DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

35,651 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE include DIARRHOEA, NAUSEA, FATIGUE, DRUG INEFFECTIVE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE.

Top Adverse Reactions

DIARRHOEA2,664 reports
NAUSEA1,569 reports
FATIGUE1,429 reports
DRUG INEFFECTIVE1,110 reports
VOMITING896 reports
WEIGHT DECREASED856 reports
PAIN769 reports
DEHYDRATION751 reports
ABDOMINAL PAIN728 reports
OFF LABEL USE725 reports
ASTHENIA698 reports
DYSPNOEA657 reports
HEADACHE654 reports
DECREASED APPETITE626 reports
MALAISE582 reports
PYREXIA570 reports
DEATH542 reports
PNEUMONIA520 reports
DIZZINESS516 reports
ARTHRALGIA506 reports
CONSTIPATION491 reports
FALL458 reports
ANAEMIA454 reports
RASH408 reports
URINARY TRACT INFECTION389 reports
PAIN IN EXTREMITY365 reports
BACK PAIN361 reports
COUGH346 reports
CROHN^S DISEASE345 reports
HYPOTENSION309 reports
ABDOMINAL PAIN UPPER302 reports
WEIGHT INCREASED285 reports
RENAL FAILURE283 reports
ANXIETY281 reports
MUSCLE SPASMS281 reports
HYPERTENSION280 reports
INSOMNIA276 reports
DISEASE PROGRESSION275 reports
DEPRESSION274 reports
BLOOD PRESSURE INCREASED267 reports
SEPSIS262 reports
DYSPEPSIA258 reports
INJECTION SITE PAIN253 reports
CHEST PAIN248 reports
ACUTE KIDNEY INJURY240 reports
ABDOMINAL DISTENSION238 reports
COLITIS237 reports
OEDEMA PERIPHERAL235 reports
ABDOMINAL DISCOMFORT232 reports
FEELING ABNORMAL229 reports
PLATELET COUNT DECREASED227 reports
FREQUENT BOWEL MOVEMENTS225 reports
DRUG HYPERSENSITIVITY223 reports
WHITE BLOOD CELL COUNT DECREASED223 reports
INFECTION221 reports
NASOPHARYNGITIS221 reports
PRURITUS221 reports
HAEMOGLOBIN DECREASED214 reports
MACULAR DEGENERATION213 reports
ALOPECIA211 reports
PERIPHERAL SWELLING207 reports
CONDITION AGGRAVATED205 reports
CONFUSIONAL STATE201 reports
GASTROINTESTINAL DISORDER201 reports
GASTROOESOPHAGEAL REFLUX DISEASE198 reports
FLATULENCE196 reports
ERYTHEMA195 reports
RECTAL HAEMORRHAGE193 reports
PRODUCT DOSE OMISSION ISSUE192 reports
HAEMATOCHEZIA190 reports
HYPOAESTHESIA189 reports
NEUROPATHY PERIPHERAL186 reports
MYALGIA184 reports
COLITIS ULCERATIVE183 reports
GAIT DISTURBANCE182 reports
BLOOD CREATININE INCREASED181 reports
SOMNOLENCE179 reports
MALIGNANT NEOPLASM PROGRESSION176 reports
SINUSITIS175 reports
DRUG INTOLERANCE174 reports
CHILLS168 reports
HYPERSENSITIVITY168 reports
HYPOKALAEMIA168 reports
THROMBOCYTOPENIA168 reports
PRODUCT USE ISSUE166 reports
INFUSION RELATED REACTION163 reports
CONTUSION160 reports
INTESTINAL OBSTRUCTION158 reports
DRUG DOSE OMISSION157 reports
MYOCARDIAL INFARCTION157 reports
INCORRECT DOSE ADMINISTERED156 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION154 reports
NEUTROPENIA154 reports
BRONCHITIS152 reports
TREMOR150 reports
DYSPHAGIA148 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE148 reports
INFLUENZA147 reports
STOMATITIS147 reports
BLOOD POTASSIUM DECREASED146 reports

Report Outcomes

Out of 13,305 classified reports for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE:

Serious 65.8%Non-Serious 34.2%

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

Female8,097 (63.7%)
Male4,597 (36.2%)
Unknown16 (0.1%)

Reports by Age

Age 71317 reports
Age 67272 reports
Age 66262 reports
Age 70261 reports
Age 65258 reports
Age 68258 reports
Age 69245 reports
Age 64241 reports
Age 72232 reports
Age 62230 reports
Age 75222 reports
Age 73220 reports
Age 63212 reports
Age 61211 reports
Age 58208 reports
Age 74205 reports
Age 60199 reports
Age 57195 reports
Age 76193 reports
Age 59183 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 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE?

This profile reflects 35,651 FDA FAERS reports that mention DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE?

Frequently reported terms in FAERS include DIARRHOEA, NAUSEA, FATIGUE, DRUG INEFFECTIVE, VOMITING, WEIGHT DECREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE. 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.