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Atropine Side Effects

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Common Atropine Side Effects


The most commonly reported Atropine side effects (click to view or check a box to report):

Headache (13)
Mydriasis (13)
Agitation (9)
Cardiac Arrest (9)
Flushing (9)
Dyspnoea (9)
Ventricular Tachycardia (8)
Hallucination (8)
Mental Status Changes (7)
Heart Rate Increased (7)
Tachycardia (7)
Sinus Tachycardia (7)
Toxicity To Various Agents (7)
Chest Pain (6)
Bradycardia (6)
Fall (6)
Nausea (6)
Vomiting (6)
Product Quality Issue (6)
Hypotension (6)

➢ More



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 Side Effects Reported to FDA



Atropine 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 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 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 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 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 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 Side Effect Report#9771318
Extrapyramidal Disorder
This Extrapyramidal 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: toxicity to various agents. On NS this consumer started treatment with Atropine (dosage: 5 Mg/hr). The following drugs were being taken at the same time:
  • Morphine (2 Mg/hr)
  • Promethazine
  • Haloperidol (2-10mg As Required)
  • Propofol
  • Pralidoxime Chloride
  • Midazolam (2 Mg/hr)
  • Diazepam
  • Dexmedetomidine
When using Atropine, the patient experienced the following unwanted symptoms/side effects: Extrapyramidal DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extrapyramidal Disorder, may become evident only after a product is in use by the general population.
Atropine Side Effect Report#9771317
Extrapyramidal Disorder
This Extrapyramidal Disorder side effect was reported by a health professional from IN. A 14-year-old female patient (weight:NA) experienced the following symptoms/conditions: toxicity to various agents.The patient was prescribed Atropine (drug dosage: 5 Mg/hr), which was initiated on NS. Concurrently used drugs:
  • Morphine (2 Mg/hr)
  • Promethazine
  • Haloperidol (2-10mg As Required)
  • Propofol
  • Pralidoxime Chloride
  • Midazolam (2 Mg/hr)
  • Diazepam
  • Dexmedetomidine
.After starting to take Atropine the consumer reported adverse symptoms, such as: Extrapyramidal DisorderThese side effects may potentially be related to Atropine.
Atropine Side Effect Report#9730409
Atrioventricular Block Second Degree
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Atropine Sulfate (dosage: 0.3 Mg, Unk, start time: NS), combined with:
  • Propofol (Unk)
  • Lidocaine (20 Mg, Unk)
  • Atracurium (Unk)
  • Isoflurane (Unk)
  • Nitrous Oxide (Unk)
  • Fentanyl (25 Ug, Unk)
  • Ephedrine (Unk)
and developed a serious reaction and side effect(s): Atrioventricular Block Second Degree after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in male patients, resulting in Atrioventricular Block Second Degree side effect.
Atropine Side Effect Report#9727477
Visual Impairment, Chest Pain, Abdominal Discomfort
This report suggests a potential Atropine Sulfate Visual Impairment side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Atropine Sulfate (dosage: Unk) starting NS. After starting Atropine Sulfate the patient began experiencing various side effects, including: Visual Impairment, Chest Pain, Abdominal DiscomfortAdditional drugs used concurrently: NA. Although Atropine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Visual Impairment, may still occur.
Atropine Side Effect Report#9723639
Atrioventricular Block Complete
This Atrioventricular Block Complete problem was reported by a physician from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: stress echocardiogram. On NS this consumer started treatment with Atropine Sulfate (dosage: 0.5 Mg (0.01 Mg/kg)). The following drugs were being taken at the same time:
  • Dobutamine (Unk)
When using Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects: Atrioventricular Block CompleteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atrioventricular Block Complete, may become evident only after a product is in use by the general population.
Atropine Side Effect Report#9631506
Face Oedema, Periorbital Oedema
This Face Oedema side effect was reported by a health professional from SG. A 3-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Atropine Sulfate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Face Oedema, Periorbital OedemaThese side effects may potentially be related to Atropine Sulfate.
Atropine Side Effect Report#9631063
Psychotic Disorder, Agitation, Hyperhidrosis, Catatonia
This is a report of a 14-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: poisoning,sedation, who was treated with Atropine Sulfate (dosage: 5 Mg/hr, start time: NS), combined with:
  • 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)
and developed a serious reaction and side effect(s): Psychotic Disorder, Agitation, Hyperhidrosis, Catatonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in female patients, resulting in Psychotic Disorder side effect.
Atropine Side Effect Report#9562886
Hypotonia, Agitation, Tremor, Tachycardia, Erythema, Mydriasis
This report suggests a potential Atropine Sulfate Hypotonia side effect(s) that can have serious consequences. A female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: ophthalmological examination and used Atropine Sulfate (dosage: 1 Gtt, Once/single) starting
Sep 04, 2013. After starting Atropine Sulfate the patient began experiencing various side effects, including: Hypotonia, Agitation, Tremor, Tachycardia, Erythema, MydriasisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Atropine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypotonia, may still occur.
Atropine Side Effect Report#9556075
Neonatal Respiratory Distress Syndrome
This Neonatal Respiratory Distress Syndrome problem was reported by a health professional from JP. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: anaesthesia. On NS this consumer started treatment with Atropine (dosage: 0.02mg). The following drugs were being taken at the same time:
  • Fentanyl (6 Microg)
  • Rocuronium Bromide (2mg)
When using Atropine, the patient experienced the following unwanted symptoms/side effects: Neonatal Respiratory Distress SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neonatal Respiratory Distress Syndrome, may become evident only after a product is in use by the general population.
Atropine Side Effect Report#9513735
Diplopia, Vision Blurred, Eye Irritation
This Diplopia side effect was reported by a health professional from FR. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Atropine Sulfate (drug dosage: 1 Drp, Unk), which was initiated on
Aug 03, 2013. Concurrently used drugs:
  • Correctol (bisacodyl) (Unk, No Treatment)
.After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Diplopia, Vision Blurred, Eye IrritationThese side effects may potentially be related to Atropine Sulfate.
Atropine Side Effect Report#9464299
Overdose, Anticholinergic Syndrome
This is a report of a 5.-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: ophthalmological examination,off label use, who was treated with Atropine Sulfate (dosage: 4 Gtt, Once/single, start time:
Jul 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Overdose, 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.
Atropine Side Effect Report#9422826
Product Label Confusion, Tachycardia, Hypertension, Ventricular Tachycardia, Headache, Palpitations
This report suggests a potential Atropine Product Label Confusion side effect(s) that can have serious consequences. A 40-year-old patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: anaesthesia and used Atropine (dosage: Unk) starting NS. After starting Atropine the patient began experiencing various side effects, including: Product Label Confusion, Tachycardia, Hypertension, Ventricular Tachycardia, Headache, PalpitationsAdditional drugs used concurrently:
  • Adrenaline (Unk)
Although Atropine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Label Confusion, may still occur.
Atropine 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 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 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 Side Effect Report#9292920
Anticholinergic Syndrome, Flushing, Tachycardia, Restlessness, Urinary Hesitation
This report suggests a potential Atropine Anticholinergic Syndrome side effect(s) that can have serious consequences. A male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: torticollis and used Atropine (dosage: NA) starting NS. After starting Atropine the patient began experiencing various side effects, including: Anticholinergic Syndrome, Flushing, Tachycardia, Restlessness, Urinary HesitationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Atropine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anticholinergic Syndrome, may still occur.
Atropine Side Effect Report#9267359
Cardiac Failure Congestive, Feeling Abnormal
This Cardiac Failure Congestive problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: diarrhoea,hypertension. On NS this consumer started treatment with Atropine Sulfate/diphenoxylate Hydrochloride (dosage: Unk). The following drugs were being taken at the same time:
  • Coreg (Unk, Two Times A Day)
  • Lisinopril (2 Mg, 1x/day)
When using Atropine Sulfate/diphenoxylate Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure Congestive, Feeling AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure Congestive, may become evident only after a product is in use by the general population.
Atropine Side Effect Report#8820540
Feeding Tube Complication, Excessive Granulation Tissue, Off Label Use
This Feeding Tube Complication side effect was reported by a health professional from GB. A 51-year-old patient (weight:NA) experienced the following symptoms/conditions: palliative care.The patient was prescribed Atropine Sulfate (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Clonidine
  • Glycopyrronium Bromide
  • Riluzole
.After starting to take Atropine Sulfate the consumer reported adverse symptoms, such as: Feeding Tube Complication, Excessive Granulation Tissue, Off Label UseThese side effects may potentially be related to Atropine Sulfate. The patient was hospitalized.
Atropine Side Effect Report#8809442
Confusional State, Hallucination, Visual, Muscular Weakness, Restlessness, Dysarthria, Swollen Tongue, Diplopia
This is a report of a 79-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: bradycardia, who was treated with Atropine Sulfate (dosage: NA, start time:
Aug 24, 2012), combined with: NA. and developed a serious reaction and side effect(s): Confusional State, Hallucination, Visual, Muscular Weakness, Restlessness, Dysarthria, Swollen Tongue, Diplopia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Atropine Sulfate treatment in female patients, resulting in Confusional State side effect. The patient was hospitalized.


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The appearance of Atropine 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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Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • 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 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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    Discuss Atropine Side Effects

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    Atropine 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

    Side Effects reported to FDA: 187

    Atropine safety alerts: No

    Reported deaths: 20

    Reported hospitalizations: 29

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