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Atropine Sulfate Side Effects

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Common Atropine Sulfate Side Effects


The most commonly reported Atropine Sulfate side effects are:
Blurred Visison (2)

If you have experienced a side effect listed above, you can check a box to report it.


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If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Atropine Sulfate Side Effects Reported to FDA



Atropine Sulfate Side Effect Report#9886734
Gait Disturbance, Speech Disorder, Toxicity To Various Agents, Cerebellar Syndrome, Dry Mouth
This is a report of a 5-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: ophthalmological examination, who was treated with Atropine Sulfate (dosage: Unk, start time: 201310), combined with: NA. and developed a serious reaction and side effect(s): Gait Disturbance, Speech Disorder, Toxicity To Various Agents, Cerebellar Syndrome, Dry Mouth after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in male patients, resulting in Gait Disturbance side effect. The patient was hospitalized.
Atropine Sulfate Side Effect Report#9885098
Accidental Exposure To Product, Toxicity To Various Agents, Depressed Level Of Consciousness, Respiratory Depression, Hypertonia
This report suggests a potential Atropine Sulfate/diphenoxylate Hydrochloride Accidental Exposure To Product side effect(s) that can have serious consequences. A 2-year-old male patient (weight: NA) from ZA was diagnosed with the following symptoms/conditions: NA and used Atropine Sulfate/diphenoxylate Hydrochloride (dosage: 10 Tablets, Unk) starting NS. After starting Atropine Sulfate/diphenoxylate Hydrochloride the patient began experiencing various side effects, including: Accidental Exposure To Product, Toxicity To Various Agents, Depressed Level Of Consciousness, Respiratory Depression, HypertoniaAdditional drugs used concurrently: NA. Although Atropine Sulfate/diphenoxylate Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Accidental Exposure To Product, may still occur.
Atropine Sulfate Side Effect Report#9833581
Mydriasis, Visual Impairment, Photophobia, Incorrect Dose Administered
This Mydriasis problem was reported by a health professional from FR. A 3-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ophthalmological examination. On
Nov 04, 2013 this consumer started treatment with Atropine Sulfate (dosage: 1 Df, Bid (morning And Evening)). The following drugs were being taken at the same time: NA. When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Mydriasis, Visual Impairment, Photophobia, Incorrect Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mydriasis, may become evident only after a product is in use by the general population.
Atropine Sulfate Side Effect Report#9816111
Hypoxic-ischaemic Encephalopathy, Brain Oedema, Coma, Respiratory Failure
This Hypoxic-ischaemic Encephalopathy side effect was reported by a pharmacist from US. A 2-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Atropine Sulfate\diphenoxylate Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Atropine Sulfate\diphenoxylate Hydrochloride the consumer reported adverse symptoms, such as: Hypoxic-ischaemic Encephalopathy, Brain Oedema, Coma, Respiratory FailureThese side effects may potentially be related to Atropine Sulfate\diphenoxylate Hydrochloride. The patient was hospitalized.
Atropine Sulfate Side Effect Report#9813823
Completed Suicide, Toxicity To Various Agents
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Atropine Sulfate/diphenoxylate Hydrochloride (dosage: NA, start time: NS), combined with:
  • Imipramine
  • Acetaminophen W/hydrocodone Bitartrate
  • Zolpidem
and developed a serious reaction and side effect(s): Completed Suicide, Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate/diphenoxylate Hydrochloride treatment in female patients, resulting in Completed Suicide side effect.
Atropine Sulfate Side Effect Report#9804696
Sinus Tachycardia, Mydriasis, Confusional State
This report suggests a potential Atropine Sulfate Sinus Tachycardia side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: eye operation and used Atropine Sulfate (dosage: Unk, Once/single) starting
Dec 09, 2013. After starting Atropine Sulfate the patient began experiencing various side effects, including: Sinus Tachycardia, Mydriasis, Confusional StateAdditional drugs used concurrently: NA. Although Atropine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sinus Tachycardia, may still occur.
Atropine Sulfate Side Effect Report#9730409
Atrioventricular Block Second Degree
This Atrioventricular Block Second Degree problem was reported by a physician from US. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Atropine Sulfate (dosage: 0.3 Mg, Unk). The following drugs were being taken at the same time:
  • Propofol (Unk)
  • Lidocaine (20 Mg, Unk)
  • Atracurium (Unk)
  • Isoflurane (Unk)
  • Nitrous Oxide (Unk)
  • Fentanyl (25 Ug, Unk)
  • Ephedrine (Unk)
When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Atrioventricular Block Second DegreeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atrioventricular Block Second Degree, may become evident only after a product is in use by the general population.
Atropine Sulfate Side Effect Report#9727477
Visual Impairment, Chest Pain, Abdominal Discomfort
This Visual Impairment side effect was reported by a consumer or non-health professional from US. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Atropine Sulfate (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Visual Impairment, Chest Pain, Abdominal DiscomfortThese side effects may potentially be related to Atropine Sulfate.
Atropine Sulfate Side Effect Report#9723639
Atrioventricular Block Complete
This is a report of a 55-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: stress echocardiogram, who was treated with Atropine Sulfate (dosage: 0.5 Mg (0.01 Mg/kg), start time: NS), combined with:
  • Dobutamine (Unk)
and developed a serious reaction and side effect(s): Atrioventricular Block Complete after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in female patients, resulting in Atrioventricular Block Complete side effect.
Atropine Sulfate Side Effect Report#9631506
Face Oedema, Periorbital Oedema
This report suggests a potential Atropine Sulfate Face Oedema side effect(s) that can have serious consequences. A 3-year-old female patient (weight: NA) from SG was diagnosed with the following symptoms/conditions: NA and used Atropine Sulfate (dosage: NA) starting NS. After starting Atropine Sulfate the patient began experiencing various side effects, including: Face Oedema, Periorbital OedemaAdditional drugs used concurrently: NA. Although Atropine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Face Oedema, may still occur.
Atropine Sulfate Side Effect Report#9631063
Psychotic Disorder, Agitation, Hyperhidrosis, Catatonia
This Psychotic Disorder problem was reported by a health professional from IN. A 14-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: poisoning,sedation. On NS this consumer started treatment with Atropine Sulfate (dosage: 5 Mg/hr). The following drugs were being taken at the same time:
  • Diazepam (10 Mg, 2x/day)
  • Haloperidol (2-10 Mg As Required)
  • Morphine Hcl (2 Mg/hr)
  • Propofol (Unk)
  • Pralidoxime Chloride (1 G, 3x/day)
  • Midazolam (2 Mg/hr)
  • Promethazine (25 Mg, 3x/day)
  • Dexmedetomidine (Unk)
When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Psychotic Disorder, Agitation, Hyperhidrosis, CatatoniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Psychotic Disorder, may become evident only after a product is in use by the general population.
Atropine Sulfate Side Effect Report#9562886
Hypotonia, Agitation, Tremor, Tachycardia, Erythema, Mydriasis
This Hypotonia side effect was reported by a health professional from FR. A female patient (weight:NA) experienced the following symptoms/conditions: ophthalmological examination.The patient was prescribed Atropine Sulfate (drug dosage: 1 Gtt, Once/single), which was initiated on
Sep 04, 2013. Concurrently used drugs: NA..After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Hypotonia, Agitation, Tremor, Tachycardia, Erythema, MydriasisThese side effects may potentially be related to Atropine Sulfate. The patient was hospitalized.
Atropine Sulfate Side Effect Report#9513735
Diplopia, Vision Blurred, Eye Irritation
This is a report of a 79-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Atropine Sulfate (dosage: 1 Drp, Unk, start time:
Aug 03, 2013), combined with:
  • Correctol (bisacodyl) (Unk, No Treatment)
and developed a serious reaction and side effect(s): Diplopia, Vision Blurred, Eye Irritation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in male patients, resulting in Diplopia side effect.
Atropine Sulfate Side Effect Report#9464299
Overdose, Anticholinergic Syndrome
This report suggests a potential Atropine Sulfate Overdose side effect(s) that can have serious consequences. A 5.-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: ophthalmological examination,off label use and used Atropine Sulfate (dosage: 4 Gtt, Once/single) starting
Jul 23, 2013. After starting Atropine Sulfate the patient began experiencing various side effects, including: Overdose, Anticholinergic SyndromeAdditional drugs used concurrently: NA. Although Atropine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Atropine Sulfate Side Effect Report#9292972
Toxicity To Various Agents, Respiratory Arrest, Cardiac Arrest, Exposure Via Inhalation, Accidental Exposure To Product, Acute Pulmonary Oedema
This Toxicity To Various Agents problem was reported by a health professional from FR. A 39-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Atropine Sulfate (dosage: Unk). The following drugs were being taken at the same time: NA. When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Respiratory Arrest, Cardiac Arrest, Exposure Via Inhalation, Accidental Exposure To Product, Acute Pulmonary OedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Atropine Sulfate Side Effect Report#9292969
Toxicity To Various Agents
This Toxicity To Various Agents side effect was reported by a health professional from FR. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: cardiac arrest.The patient was prescribed Atropine Sulfate (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Adrenaline
.After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Toxicity To Various AgentsThese side effects may potentially be related to Atropine Sulfate.
Atropine Sulfate Side Effect Report#9292968
Toxicity To Various Agents
This is a report of a 46-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: ventricular fibrillation, who was treated with Atropine Sulfate (dosage: 2 Mg, Unk, start time: NS), combined with:
  • Adrenaline
and developed a serious reaction and side effect(s): Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in male patients, resulting in Toxicity To Various Agents side effect.
Atropine Sulfate Side Effect Report#9267359
Cardiac Failure Congestive, Feeling Abnormal
This report suggests a potential Atropine Sulfate/diphenoxylate Hydrochloride Cardiac Failure Congestive side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diarrhoea,hypertension and used Atropine Sulfate/diphenoxylate Hydrochloride (dosage: Unk) starting NS. After starting Atropine Sulfate/diphenoxylate Hydrochloride the patient began experiencing various side effects, including: Cardiac Failure Congestive, Feeling AbnormalAdditional drugs used concurrently:
  • Coreg (Unk, Two Times A Day)
  • Lisinopril (2 Mg, 1x/day)
Although Atropine Sulfate/diphenoxylate Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Congestive, may still occur.
Atropine Sulfate Side Effect Report#8820540
Feeding Tube Complication, Excessive Granulation Tissue, Off Label Use
This Feeding Tube Complication problem was reported by a health professional from GB. A 51-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: palliative care. On NS this consumer started treatment with Atropine Sulfate (dosage: NA). The following drugs were being taken at the same time:
  • Clonidine
  • Glycopyrronium Bromide
  • Riluzole
When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Feeding Tube Complication, Excessive Granulation Tissue, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Feeding Tube Complication, may become evident only after a product is in use by the general population.
Atropine Sulfate Side Effect Report#8809442
Confusional State, Hallucination, Visual, Muscular Weakness, Restlessness, Dysarthria, Swollen Tongue, Diplopia
This Confusional State side effect was reported by a health professional from GB. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: bradycardia.The patient was prescribed Atropine Sulfate (drug dosage: NA), which was initiated on
Aug 24, 2012. Concurrently used drugs: NA..After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Confusional State, Hallucination, Visual, Muscular Weakness, Restlessness, Dysarthria, Swollen Tongue, DiplopiaThese side effects may potentially be related to Atropine Sulfate. The patient was hospitalized.
Atropine Sulfate Side Effect Report#8776885
Overdose, Administration Related Reaction, Delirium, Mydriasis, Mucosal Dryness, Tachycardia, Dysarthria, Bladder Dilatation, Anticholinergic Syndrome
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: gingival disorder, who was treated with Atropine Sulfate (dosage: 2 Ml Of Ophthalmic Atropine (10 Mg/ml), start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Overdose, Administration Related Reaction, Delirium, Mydriasis, Mucosal Dryness, Tachycardia, Dysarthria, Bladder Dilatation, Anticholinergic Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in male patients, resulting in Overdose side effect. The patient was hospitalized.
Atropine Sulfate Side Effect Report#8724176
Cough, Nausea, Vomiting, Anxiety, Throat Irritation
This report suggests a potential Atropine Sulfate\hyoscyamine Sulfate\phenobarbital\scopolamine Hydrobromide Cough side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: irritable bowel syndrome and used Atropine Sulfate\hyoscyamine Sulfate\phenobarbital\scopolamine Hydrobromide (dosage: 1 Tsp/q4h@100 Lbs) starting
Jul 05, 2012. After starting Atropine Sulfate\hyoscyamine Sulfate\phenobarbital\scopolamine Hydrobromide the patient began experiencing various side effects, including: Cough, Nausea, Vomiting, Anxiety, Throat IrritationAdditional drugs used concurrently:
  • Hyzaar
Although Atropine Sulfate\hyoscyamine Sulfate\phenobarbital\scopolamine Hydrobromide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cough, may still occur.
Atropine Sulfate Side Effect Report#8462315-X
Headache, Hyperhidrosis, Feeling Cold, Visual Impairment
This Headache problem was reported by a health professional from France. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oligodendroglioma. On
Mar 16, 2012 this consumer started treatment with Atropine Sulfate (dosage: 1 Df, Unk). The following drugs were being taken at the same time:
  • Zofran (8 Mg/4 Ml, 1 Df, Unk)
  • Irinotecan Hcl (220 Mg, Cyclic)
  • Avastin (820 Mg, Unk)
  • Methylprednisolone Merck (60 Mg, Unk)
When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Headache, Hyperhidrosis, Feeling Cold, Visual ImpairmentThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Headache, may become evident only after a product is in use by the general population.
Atropine Sulfate Side Effect Report#8378769-3
Bronchospasm, Muscle Spasms, Confusional State, Agitation
This Bronchospasm side effect was reported by a health professional from Brazil. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Atropine Sulfate (drug dosage: 40 Gtt, Single), which was initiated on
May 07, 2012. Concurrently used drugs: NA..After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Bronchospasm, Muscle Spasms, Confusional State, AgitationThese side effects may potentially be related to Atropine Sulfate. The patient was hospitalized.
Atropine Sulfate Side Effect Report#8355533-2
Bronchospasm, Confusional State, Agitation, Muscle Spasms
This is a report of a 32-year-old male patient (weight: NA) from Brazil, suffering from the following health symptoms/conditions: NA, who was treated with Atropine Sulfate (dosage: 40 Gtt, Single, start time:
May 07, 2012), combined with: NA. and developed a serious reaction and side effect(s): Bronchospasm, Confusional State, Agitation, Muscle Spasms after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in male patients, resulting in Bronchospasm side effect. The patient was hospitalized.


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The appearance of Atropine Sulfate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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Why Your Notes are Important

Your notes could be helpful in several ways:

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  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Atropine Sulfate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Atropine Sulfate Safety Alerts, Active Ingredients, Usage Information

    NDC0054-3194
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDiphenoxylate Hydrochloride and Atropine Sulfate
    NameDiphenoxylate Hydrochloride and Atropine Sulfate
    Dosage FormSOLUTION
    RouteORAL
    On market since19820503
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
    Strength(s).025; 2.5
    Unit(s)mg/5mL; mg/5mL
    Pharma ClassAnticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Choliner

    More About Atropine sulfate

    Side Effects reported to FDA: 95

    Atropine Sulfate safety alerts: No

    Reported deaths: 20

    Reported hospitalizations: 28

    Latest Atropine Sulfate clinical trials

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