ATROPINE SULFATE

N/A

Manufactured by Apotex Corp.

21,488 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ATROPINE SULFATE

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

Top Adverse Reactions

DRUG INEFFECTIVE904 reports
OFF LABEL USE749 reports
DIARRHOEA671 reports
NAUSEA634 reports
HYPOTENSION559 reports
DEATH558 reports
FATIGUE464 reports
PAIN460 reports
VOMITING459 reports
DYSPNOEA449 reports
BRADYCARDIA439 reports
PYREXIA435 reports
CARDIAC ARREST368 reports
TOXICITY TO VARIOUS AGENTS358 reports
HEADACHE351 reports
CONSTIPATION330 reports
FALL298 reports
ABDOMINAL PAIN296 reports
ASTHENIA292 reports
HYPERTENSION291 reports
DRUG INTERACTION289 reports
MALAISE289 reports
TACHYCARDIA270 reports
ANAEMIA251 reports
PNEUMONIA249 reports
WEIGHT DECREASED249 reports
ERYTHEMA245 reports
MACULAR DEGENERATION243 reports
ACUTE KIDNEY INJURY220 reports
RENAL FAILURE220 reports
CONDITION AGGRAVATED216 reports
DECREASED APPETITE207 reports
DIZZINESS205 reports
OVERDOSE204 reports
SOMNOLENCE203 reports
ANXIETY198 reports
NEUTROPENIA198 reports
FEBRILE NEUTROPENIA196 reports
CONFUSIONAL STATE190 reports
DISEASE PROGRESSION177 reports
RESPIRATORY FAILURE173 reports
HYPERHIDROSIS171 reports
RASH170 reports
DEHYDRATION166 reports
INFUSION RELATED REACTION156 reports
CHEST PAIN153 reports
THROMBOCYTOPENIA153 reports
ATRIAL FIBRILLATION152 reports
SEIZURE152 reports
DYSPEPSIA150 reports
NEUROPATHY PERIPHERAL147 reports
COUGH144 reports
ARTHRALGIA142 reports
DYSARTHRIA141 reports
PRODUCT USE IN UNAPPROVED INDICATION141 reports
HAEMATOCHEZIA138 reports
GENERAL PHYSICAL HEALTH DETERIORATION135 reports
RHABDOMYOLYSIS135 reports
CARDIO RESPIRATORY ARREST134 reports
PRURITUS132 reports
AGITATION131 reports
DRUG HYPERSENSITIVITY131 reports
VISION BLURRED129 reports
MUSCULAR WEAKNESS127 reports
VENTRICULAR TACHYCARDIA127 reports
DEPRESSED LEVEL OF CONSCIOUSNESS126 reports
RECTAL HAEMORRHAGE126 reports
URINARY TRACT INFECTION125 reports
PAIN IN EXTREMITY124 reports
BLOOD PRESSURE DECREASED123 reports
STRESS CARDIOMYOPATHY122 reports
PULMONARY EMBOLISM121 reports
TREMOR121 reports
SEPSIS120 reports
LOSS OF CONSCIOUSNESS119 reports
PULMONARY OEDEMA119 reports
GAIT DISTURBANCE117 reports
METABOLIC ACIDOSIS116 reports
PARAESTHESIA ORAL116 reports
CARDIOGENIC SHOCK115 reports
COLITIS115 reports
COMA114 reports
BALANCE DISORDER113 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE113 reports
EYE PAIN112 reports
MOBILITY DECREASED112 reports
BACK PAIN110 reports
SEDATION110 reports
MYDRIASIS109 reports
OXYGEN SATURATION DECREASED109 reports
CHRONIC KIDNEY DISEASE108 reports
HEART RATE INCREASED108 reports
DEPRESSION107 reports
OEDEMA PERIPHERAL105 reports
BLOOD PRESSURE INCREASED104 reports
PARAESTHESIA104 reports
PROCEDURAL PAIN104 reports
ANAPHYLACTIC REACTION103 reports
HAEMOGLOBIN DECREASED102 reports
INSOMNIA102 reports

Report Outcomes

Out of 10,326 classified reports for ATROPINE SULFATE:

Serious 90.0%Non-Serious 10.0%

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

Male4,585 (50.0%)
Female4,505 (49.2%)
Unknown71 (0.8%)

Reports by Age

Age 71217 reports
Age 67188 reports
Age 65183 reports
Age 72172 reports
Age 68171 reports
Age 62164 reports
Age 69159 reports
Age 58158 reports
Age 70156 reports
Age 77153 reports
Age 56145 reports
Age 57145 reports
Age 64145 reports
Age 63143 reports
Age 61134 reports
Age 60132 reports
Age 75132 reports
Age 66131 reports
Age 73129 reports
Age 55128 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 ATROPINE SULFATE?

This profile reflects 21,488 FDA FAERS reports that mention ATROPINE SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ATROPINE SULFATE?

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

Who manufactures ATROPINE SULFATE?

Labeling and FAERS entries often list Apotex Corp. in connection with 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.