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ATROPINE SULFATE

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Atropine Sulfate Adverse Events Reported to the FDA Over Time

How are Atropine Sulfate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Atropine Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Atropine Sulfate is flagged as the suspect drug causing the adverse event.

Most Common Atropine Sulfate Adverse Events Reported to the FDA

What are the most common Atropine Sulfate adverse events reported to the FDA?

Completed Suicide
47 (3.25%)
Drug Rash With Eosinophilia And Sys...
34 (2.35%)
Agitation
18 (1.24%)
Mydriasis
18 (1.24%)
Toxic Encephalopathy
18 (1.24%)
Constipation
17 (1.18%)
Confusional State
16 (1.11%)
Medication Error
16 (1.11%)
Bradycardia
15 (1.04%)
Convulsion
14 (.97%)
Disseminated Intravascular Coagulat...
14 (.97%)
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Flushing
14 (.97%)
Nausea
14 (.97%)
Diarrhoea
13 (.9%)
Drug Ineffective
13 (.9%)
Respiratory Arrest
13 (.9%)
Toxic Epidermal Necrolysis
13 (.9%)
Dehydration
12 (.83%)
Pyrexia
12 (.83%)
Tachycardia
12 (.83%)
Vomiting
12 (.83%)
Weight Decreased
12 (.83%)
Cardiac Arrest
11 (.76%)
Dyspnoea
11 (.76%)
Multiple Drug Overdose
11 (.76%)
Pain
11 (.76%)
Rash
11 (.76%)
Blood Pressure Decreased
10 (.69%)
Decreased Appetite
10 (.69%)
Delirium
10 (.69%)
Oxygen Saturation Decreased
10 (.69%)
Coma
9 (.62%)
Condition Aggravated
9 (.62%)
Death
9 (.62%)
Disorientation
9 (.62%)
Fatigue
9 (.62%)
Hallucination, Visual
9 (.62%)
Insomnia
9 (.62%)
Mental Status Changes
9 (.62%)
Visual Impairment
9 (.62%)
Anaphylactic Shock
8 (.55%)
Hypotension
8 (.55%)
Tachypnoea
8 (.55%)
Abdominal Distension
7 (.48%)
Asthenia
7 (.48%)
Drug Interaction
7 (.48%)
Haematocrit Decreased
7 (.48%)
Haemoglobin Decreased
7 (.48%)
Heart Rate Increased
7 (.48%)
Hypertension
7 (.48%)
Injection Site Ulcer
7 (.48%)
Loss Of Consciousness
7 (.48%)
Memory Impairment
7 (.48%)
Miosis
7 (.48%)
Muscle Spasms
7 (.48%)
Pseudodementia
7 (.48%)
Urinary Tract Infection
7 (.48%)
Vision Blurred
7 (.48%)
Accidental Overdose
6 (.41%)
Aneurysm Ruptured
6 (.41%)
Anxiety
6 (.41%)
Blood Pressure Increased
6 (.41%)
Drug Toxicity
6 (.41%)
Dry Mouth
6 (.41%)
Erythema
6 (.41%)
Fall
6 (.41%)
Hallucination
6 (.41%)
Heart Rate Decreased
6 (.41%)
Infection
6 (.41%)
Lymphocyte Stimulation Test Positiv...
6 (.41%)
Post Procedural Complication
6 (.41%)
Protein Total Decreased
6 (.41%)
Somnolence
6 (.41%)
Syncope
6 (.41%)
Urticaria
6 (.41%)
Aspiration
5 (.35%)
Blindness
5 (.35%)
Bronchospasm
5 (.35%)
Depressed Level Of Consciousness
5 (.35%)
Depression
5 (.35%)
Haematuria
5 (.35%)
Headache
5 (.35%)
Incorrect Route Of Drug Administrat...
5 (.35%)
Malaise
5 (.35%)
Muscular Weakness
5 (.35%)
Oliguria
5 (.35%)
Psychotic Disorder
5 (.35%)
Pulmonary Oedema
5 (.35%)
Stress Cardiomyopathy
5 (.35%)
Tremor
5 (.35%)
Ventricular Tachycardia
5 (.35%)
Abnormal Behaviour
4 (.28%)
Anaphylactoid Shock
4 (.28%)
Apnoea
4 (.28%)
Device Failure
4 (.28%)
Drug Eruption
4 (.28%)
Drug Hypersensitivity
4 (.28%)
Endophthalmitis
4 (.28%)
Flatulence
4 (.28%)
Gait Disturbance
4 (.28%)
Laryngeal Oedema
4 (.28%)

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This graph shows the top adverse events submitted to the FDA for Atropine Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Atropine Sulfate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Atropine Sulfate

What are the most common Atropine Sulfate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Atropine Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Atropine Sulfate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Atropine Sulfate According to Those Reporting Adverse Events

Why are people taking Atropine Sulfate, according to those reporting adverse events to the FDA?

Diarrhoea
107
Drug Use For Unknown Indication
91
Product Used For Unknown Indication
85
Premedication
52
Irritable Bowel Syndrome
36
Anaesthetic Premedication
34
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Crohns Disease
29
Anaesthesia Reversal
24
Anaesthesia
24
Bradycardia
21
Abdominal Pain
20
Induction Of Anaesthesia
17
Stress Echocardiogram
13
Abdominal Pain Upper
12
Ureteral Stent Insertion
9
Ureteral Stent Removal
9
Endotracheal Intubation
9
Gastrooesophageal Reflux Disease
9
Neuromuscular Blockade Reversal
8
Abdominal Discomfort
8
Prophylaxis
7
Cardiac Arrest
7
Salivary Hypersecretion
7
Gastric Disorder
6
Preoperative Care
6
Accidental Drug Intake By Child
6
General Anaesthesia
6
Pain
6
Anaesthesia Procedure
6
Muscle Spasms
5
Surgery
5
Nausea
5
Ophthalmological Examination
4
Ill-defined Disorder
4
Pancreatitis Acute
4
Arrhythmia
4
Drug Toxicity
4
Gastrointestinal Carcinoma
4
Cardiac Pacemaker Replacement
4
Colitis Ulcerative
3
Abnormal Faeces
3
Completed Suicide
3
Cholinergic Syndrome
3
Miosis
3
Gastrointestinal Hypomotility
3
Off Label Use
3
Intestinal Spasm
3
Gastrointestinal Hypermotility
3
Inflammation
3
Strabismus
3
Drug Therapy
3

Drug Labels

LabelLabelerEffective
Diphenoxylate Hydrochloride And Atropine SulfateBryant Ranch Prepack26-MAY-00
Isopto Atropine Alcon Laboratories, Inc.01-AUG-03
Diphenoxylate Hydrochloride And Atropine SulfateMylan Pharmaceuticals Inc.19-NOV-09
Diphenoxylate Hydrochloride And Atropine SulfatePD-Rx Pharmaceuticals, Inc.19-NOV-09
Diphenoxylate Hydrochloride And Atropine SulfatePD-Rx Pharmaceuticals, Inc.19-NOV-09
Diphenoxylate Hcl And Atropine SulfateStat Rx USA24-MAR-10
LomotilG.D. Searle LLC Division of Pfizer Inc19-APR-10
Diphenoxylate Hydrochloride And Atropine SulfateUDL Laboratories, Inc.30-APR-10
Atropine SulfateMcKesson Packaging Services Business Unit of McKesson Corporation03-MAY-10
MotofenValeant Pharmaceutical02-JUL-10
Atropine SulfateGeneral Injectables & Vaccines, Inc09-AUG-10
Atropine SulfateGeneral Injectables & Vaccines, Inc10-AUG-10
Atropine SulfateGeneral Injectables & Vaccines, Inc19-AUG-10
Diphenoxylate Hydrochloride And Atropine SulfateRebel Distributors Corp22-SEP-10
Atropine SulfateGeneral Injectables & Vaccines, Inc18-JAN-11
Diphenoxylate Hydrochloride And Atropine SulfatePhysicians Total Care, Inc.25-JAN-11
Diphenoxylate Hydrochloride And Atropine SulfateCardinal Health21-MAR-11
Atropine Sulfate General Injectables & Vaccines, Inc27-APR-11
Diphenoxylate Hydrochloride And Atropine SulfateRedPharm Drug, Inc.24-MAY-11
Atropine SulfateHospira, Inc.29-JUN-11
Diphenoxylate Hydrochloride And Atropine SulfatePreferred Pharmaceuticals, Inc07-SEP-11
Atropine Sulfate Alcon Laboratories, Inc.20-SEP-11
Atropine Sulfate FALCON LABORATORY LTD23-SEP-11
Atropine SulfateAmerican Regent, Inc.29-SEP-11
Diphenoxylate Hydrochloride And Atropine SulfateCadinal Health10-OCT-11
Atropine SulfateWest-ward Pharmaceutical Corp.16-NOV-11
Atropine SulfateGeneral Injectables & Vaccines, Inc.23-JAN-12
Atropine SulfateCardinal Health30-JAN-12
Diphenoxylate Hydrochloride And Atropine SulfateDispensing Solutions, Inc.17-FEB-12
Atropine Sulfate General Injectables & Vaccines, Inc.09-MAR-12
Atropine SulfateGeneral Injectables & Vaccines, Inc08-MAY-12
Diphenoxylate Hydrochloride And Atropine SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-MAY-12
Diphenoxylate Hydrochloride And Atropine SulfatePar Pharmaceutical, Inc.30-MAY-12
Atropine SulfateAkorn, Inc.08-JUN-12
Diphenoxylate Hydrochloride And Atropine SulfateRoxane Laboratories, Inc01-AUG-12
Atropine SulfateBausch & Lomb Incorporated06-AUG-12
Atropine SulfateBausch & Lomb Incorporated07-AUG-12
Diphenoxylate Hydrochloride And Atropine SulfateMcKesson Contract Packaging13-SEP-12
Atropine Sulfate International Medication Systems, Limited 24-SEP-12
Atropine SulfateHospira, Inc.14-DEC-12
Atropine SulfateAmphastar Pharmaceuticals, Inc.10-JAN-13
Diphenoxylate Hydrochloride And Atropine SulfateGreenstone LLC22-FEB-13
Atropine SulfateCardinal Health07-MAR-13
Diphenoxylate Hydrochloride And Atropine SulfateCardinal Health05-APR-13
Diphenoxylate Hydrochloride And Atropine SulfateA-S Medication Solutions LLC24-APR-13

Atropine Sulfate Case Reports

What Atropine Sulfate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Atropine Sulfate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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