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Atropine Side Effects

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.

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.

Atropine Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Gait Disturbance
  • Speech Disorder
  • Toxicity To Various Agents
  • Cerebellar Syndrome
  • Dry Mouth
which developed 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.

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, Toxicity To Various Agents, Depressed Level Of Consciousness, Respiratory Depression, Hypertonia 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. Soon 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
  • Hypertonia
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.

Mydriasis, Visual Impairment, Photophobia, Incorrect Dose Administered
This Mydriasis, Visual Impairment, Photophobia, Incorrect Dose Administered 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 commencing Atropine Sulfate, the patient experienced the following unwanted symptoms/side effects:
  • Mydriasis
  • Visual Impairment
  • Photophobia
  • Incorrect Dose Administered
Although 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.

Hypoxic-ischaemic Encephalopathy, Brain Oedema, Coma, Respiratory Failure
This is a report of a 2-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Atropine Sulfate\diphenoxylate Hydrochloride (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Hypoxic-ischaemic Encephalopathy
  • Brain Oedema
  • Coma
  • Respiratory Failure
The patient was hospitalized. This opens a possibility that Atropine Sulfate\diphenoxylate Hydrochloride treatment could cause the above reactions, including hypoxic-ischaemic encephalopathy, and some female subjects may be more susceptible.


Completed Suicide, Toxicity To Various Agents
A 64-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Atropine Sulfate/diphenoxylate Hydrochloride treatment (dosage: NA) on NS. Soon after starting Atropine Sulfate/diphenoxylate Hydrochloride treatment, the subject experienced various side effects, including:
  • Completed Suicide
  • Toxicity To Various Agents
Concurrently used drugs:
  • Imipramine
  • Acetaminophen W/hydrocodone Bitartrate
  • Zolpidem
This finding indicates that some female patients could be more vulnerable to Atropine Sulfate/diphenoxylate Hydrochloride.

Sinus Tachycardia, Mydriasis, Confusional State
A 71-year-old female patient from FR (weight: NA) experienced symptoms, such as: eye operation and was treated with Atropine Sulfate(dosage: Unk, Once/single). The treatment was initiated on Dec 09, 2013. After that a consumer reported the following side effect(s):
  • Sinus Tachycardia
  • Mydriasis
  • Confusional State
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Atropine Sulfate efficacy: NA.

Extrapyramidal Disorder
In this report, Atropine was administered for the following condition: toxicity to various agents.A 14-year-old female consumer from IN (weight: NA) started Atropine treatment (dosage: 5 Mg/hr) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Extrapyramidal Disorder
A possible interaction with other drugs could have contributed to this reaction:
  • Morphine (2 Mg/hr)
  • Promethazine
  • Haloperidol (2-10mg As Required)
  • Propofol
  • Pralidoxime Chloride
  • Midazolam (2 Mg/hr)
  • Diazepam
  • Dexmedetomidine
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Atropine treatment could be related to the listed above side effect(s).

Extrapyramidal Disorder
This is a report of the following Atropine side effect(s):
  • Extrapyramidal Disorder
A 14-year-old female patient from IN (weight: NA) presented with the following condition: toxicity to various agents and received a treatment with Atropine (dosage: 5 Mg/hr) starting: NS.The following concurrently used drugs could have generated interactions:
  • Morphine (2 Mg/hr)
  • Promethazine
  • Haloperidol (2-10mg As Required)
  • Propofol
  • Pralidoxime Chloride
  • Midazolam (2 Mg/hr)
  • Diazepam
  • Dexmedetomidine
This report suggests that a Atropine treatment could be associated with the listed above side effect(s).

Atrioventricular Block Second Degree
This Atropine Sulfate report was submitted by a 57-year-old male consumer from US (weight: NA). The patient was diagnosed with: NA and Atropine Sulfate was administered (dosage: 0.3 Mg, Unk) starting: NS. The consumer developed a set of symptoms:
  • Atrioventricular Block Second Degree
Other drugs used simultaneously:
  • Propofol (Unk)
  • Lidocaine (20 Mg, Unk)
  • Atracurium (Unk)
  • Isoflurane (Unk)
  • Nitrous Oxide (Unk)
  • Fentanyl (25 Ug, Unk)
  • Ephedrine (Unk)
Those unexpected symptoms could be linked to a Atropine Sulfate treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Visual Impairment, Chest Pain, Abdominal Discomfort
This is a report of a possible correlation between Atropine Sulfate use and the following symptoms/side effect(s):
  • Visual Impairment
  • Chest Pain
  • Abdominal Discomfort
which could contribute to an assessment of Atropine Sulfate risk profile.A 80-year-old female consumer from US (weight: NA) was suffering from NA and was treated with Atropine Sulfate (dosage: Unk) starting NS.Other concurrent medications: NA.

Atrioventricular Block Complete
A 55-year-old female patient from US (weight: NA) presented with the following symptoms: stress echocardiogram and after a treatment with Atropine Sulfate (dosage: 0.5 Mg (0.01 Mg/kg)) experienced the following side effect(s):
  • Atrioventricular Block Complete
The treatment was started on NS. Atropine Sulfate was used in combination with the following drugs:
  • Dobutamine (Unk)
This report could alert potential Atropine Sulfate consumers.

Face Oedema, Periorbital Oedema
In this report, a 3-year-old female patient from SG (weight: NA) was affected by a possible Atropine Sulfate side effect.The patient was diagnosed with NA. After a treatment with Atropine Sulfate (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Face Oedema
  • Periorbital Oedema
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Atropine Sulfate treatment.

Psychotic Disorder, Agitation, Hyperhidrosis, Catatonia
This is a report of a 14-year-old female patient from IN (weight: NA), who used Atropine Sulfate (dosage: 5 Mg/hr) for a treatment of poisoning,sedation. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Psychotic Disorder
  • Agitation
  • Hyperhidrosis
  • Catatonia
The following drugs could possibly have interacted with the Atropine Sulfate treatment
  • 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)
Taken together, these observations suggest that a Atropine Sulfate treatment could be related to side effect(s), such as Psychotic Disorder, Agitation, Hyperhidrosis, Catatonia.

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 (dosage: 1 Gtt, Once/single), which was started on Sep 04, 2013. Concurrently used drugs: NA. When starting to take Atropine Sulfate the consumer reported the following symptoms:
  • Hypotonia
  • Agitation
  • Tremor
  • Tachycardia
  • Erythema
  • Mydriasis
The patient was hospitalized. These side effects may potentially be related to Atropine Sulfate.

Neonatal Respiratory Distress Syndrome
This is a Atropine side effect report of a female patient (weight:NA) from JP, suffering from the following symptoms/conditions: anaesthesia, who was treated with Atropine (dosage:0.02mg, start time: NS), combined with:
  • Fentanyl (6 Microg)
  • Rocuronium Bromide (2mg)
, and developed a serious reaction and a neonatal respiratory distress syndrome side effect. The patient presented with:
  • Neonatal Respiratory Distress Syndrome
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Atropine treatment in female patients suffering from anaesthesia, resulting in neonatal respiratory distress syndrome.

Diplopia, Vision Blurred, Eye Irritation
This report suggests a potential Atropine Sulfate diplopia side effect(s) that can have serious consequences. A 79-year-old male patient from FR (weight:NA) was diagnosed with the following health condition(s): NA and used Atropine Sulfate (dosage: 1 Drp, Unk) starting Aug 03, 2013. Soon after starting Atropine Sulfate the patient began experiencing various side effects, including:
  • Diplopia
  • Vision Blurred
  • Eye Irritation
Drugs used concurrently:
  • Correctol (bisacodyl) (Unk, No Treatment)
Although Atropine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as diplopia, may still occur.

Overdose, Anticholinergic Syndrome
This overdose problem was reported by a health professional from FR. A 5.-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): ophthalmological examination,off label use.On Jul 23, 2013 a consumer started treatment with Atropine Sulfate (dosage: 4 Gtt, Once/single). The following drugs/medications were being taken at the same time: NA. When commencing Atropine Sulfate, the patient experienced the following unwanted symptoms /side effects:
  • Overdose
  • Anticholinergic Syndrome
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as overdose, may become evident only after a product is in use by the general population.

Product Label Confusion, Tachycardia, Hypertension, Ventricular Tachycardia, Headache, Palpitations
This is a Atropine side effect report of a 40-year-old patient (weight: NA) from IN. The patient developed the following symptoms/conditions: anaesthesia and was treated with Atropine (dosage: Unk) starting NS. Concurrently used drugs:
  • Adrenaline (Unk)
Soon after that, the consumer experienced the following of symptoms:
  • Product Label Confusion
  • Tachycardia
  • Hypertension
  • Ventricular Tachycardia
  • Headache
  • Palpitations
This opens a possibility that Atropine could cause product label confusion and that some patients may be more susceptible.

Toxicity To Various Agents, Respiratory Arrest, Cardiac Arrest, Exposure Via Inhalation, Accidental Exposure To Product, Acute Pulmonary Oedema
A 39-year-old male patient (weight: NA) from FR with the following symptoms: NA started Atropine Sulfate treatment (dosage: Unk) on NS. Soon after starting Atropine Sulfate treatment, the consumer experienced several side effects, including:
  • Toxicity To Various Agents
  • Respiratory Arrest
  • Cardiac Arrest
  • Exposure Via Inhalation
  • Accidental Exposure To Product
  • Acute Pulmonary Oedema
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Atropine Sulfate side effects, such as toxicity to various agents.

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 (dosage: Unk), which was started on NS. Concurrently used drugs:
  • Adrenaline
.When starting to take Atropine Sulfate the consumer reported symptoms, such as:
  • Toxicity To Various Agents
These side effects may potentially be related to Atropine Sulfate.

Toxicity To Various Agents
This is a report of a 46-year-old male patient (weight: NA) from FR, suffering from the following 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). The consumer presented with:
  • Toxicity To Various Agents
which developed 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.

Anticholinergic Syndrome, Flushing, Tachycardia, Restlessness, Urinary Hesitation
This report suggests a potential Atropine Anticholinergic Syndrome, Flushing, Tachycardia, Restlessness, Urinary Hesitation 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. Soon after starting Atropine the patient began experiencing various side effects, including:
  • Anticholinergic Syndrome
  • Flushing
  • Tachycardia
  • Restlessness
  • Urinary Hesitation
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.

Cardiac Failure Congestive, Feeling Abnormal
This Cardiac Failure Congestive, Feeling Abnormal 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 commencing Atropine Sulfate/diphenoxylate Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Cardiac Failure Congestive
  • Feeling Abnormal
Although 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.

Feeding Tube Complication, Excessive Granulation Tissue, Off Label Use
This is a report of a 51-year-old patient (weight: NA) from GB. The patient developed the following symptoms/conditions: palliative care and was treated with Atropine Sulfate (dosage: NA) starting NS. Concurrently used drugs:
  • Clonidine
  • Glycopyrronium Bromide
  • Riluzole
Soon after that, the consumer experienced the following side effects:
  • Feeding Tube Complication
  • Excessive Granulation Tissue
  • Off Label Use
The patient was hospitalized. This opens a possibility that Atropine Sulfate treatment could cause the above reactions, including feeding tube complication, and some subjects may be more susceptible.

Confusional State, Hallucination, Visual, Muscular Weakness, Restlessness, Dysarthria, Swollen Tongue, Diplopia
A 79-year-old female patient (weight: NA) from GB with the following symptoms/conditions: bradycardia started Atropine Sulfate treatment (dosage: NA) on Aug 24, 2012. Soon after starting Atropine Sulfate treatment, the subject experienced various side effects, including:
  • Confusional State
  • Hallucination, Visual
  • Muscular Weakness
  • Restlessness
  • Dysarthria
  • Swollen Tongue
  • Diplopia
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Atropine Sulfate.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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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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