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Flecainide Side Effects

Common Flecainide Side Effects


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

Electrocardiogram Qrs Complex Prolonged (37)
Toxicity To Various Agents (32)
Atrial Fibrillation (32)
Syncope (29)
Hypotension (29)
Dyspnoea (29)
Bradycardia (28)
Ventricular Tachycardia (27)
Cardiac Arrest (26)
Dizziness (24)
Asthenia (23)
Atrial Flutter (23)
Electrocardiogram Qt Prolonged (23)
Intentional Overdose (23)
Loss Of Consciousness (22)
Torsade De Pointes (21)
Tachycardia (21)
Overdose (20)
Electrocardiogram Abnormal (18)
Nausea (18)

➢ 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.

Flecainide Side Effects Reported to FDA

The following Flecainide 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 Flecainide 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.
Ventricular Tachycardia, Overdose
This is a report of a 72-year-old female patient (weight: NA) from FR, suffering from the following symptoms/conditions: atrial fibrillation, who was treated with Flecainide (dosage: 100 Mg, Bid, start time: NS), combined with:
  • Haloperidol (1 Mg, Bid)
  • Irbesartan (300 Mg, Daily)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Ventricular Tachycardia
  • Overdose
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Flecainide treatment in female patients, resulting in ventricular tachycardia side effect. The patient was hospitalized.

Atrioventricular Block First Degree, Hypotension, Sopor
This report suggests a potential Flecainide Acetate Atrioventricular Block First Degree, Hypotension, Sopor side effect(s) that can have serious consequences. A 34-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: intentional self-injury and used Flecainide Acetate (dosage: 300 Milligram Daily;) starting Jan 21, 2014. Soon after starting Flecainide Acetate the patient began experiencing various side effects, including:
  • Atrioventricular Block First Degree
  • Hypotension
  • Sopor
Drugs used concurrently:
  • Mirtazapine (900 Milligram Daily;)
  • Buscofen
  • Sotalol Hydrochloride
  • Sertraline Hydrochloride
  • Bromazepam
The patient was hospitalized. Although Flecainide Acetate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as atrioventricular block first degree, may still occur.

Left Ventricular Failure, Left Ventricular Hypertrophy, Systolic Dysfunction, Dyspnoea, Ejection Fraction Decreased, Ventricular Tachycardia, Overdose
This Left Ventricular Failure, Left Ventricular Hypertrophy, Systolic Dysfunction, Dyspnoea, Ejection Fraction Decreased, Ventricular Tachycardia, Overdose problem was reported by a health professional from FR. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Flecainide (dosage: 100 Mg, Bid). The following drugs were being taken at the same time:
  • Irbesartan
  • Haloperidol
  • Amiodarone
When commencing Flecainide, the patient experienced the following unwanted symptoms/side effects:
  • Left Ventricular Failure
  • Left Ventricular Hypertrophy
  • Systolic Dysfunction
  • Dyspnoea
  • Ejection Fraction Decreased
  • Ventricular Tachycardia
  • Overdose
The 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 left ventricular failure, may become evident only after a product is in use by the general population.

Poisoning, Completed Suicide, Exposure Via Ingestion
This is a report of a 31-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Flecainide (dosage: NA) starting NS. Concurrently used drugs:
  • Quetiapine
  • Citalopram (P.o.)
  • Oxycodone
  • Alprazolam
Soon after that, the consumer experienced the following side effects:
  • Poisoning
  • Completed Suicide
  • Exposure Via Ingestion
This opens a possibility that Flecainide treatment could cause the above reactions, including poisoning, and some male subjects may be more susceptible.


Product Quality Issue
A 54-year-old male patient (weight: NA) from US with the following symptoms/conditions: atrial fibrillation started Flecainide treatment (dosage: 300 Mg) on NS. Soon after starting Flecainide treatment, the subject experienced various side effects, including:
  • Product Quality Issue
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Flecainide.

Poisoning, Exposure Via Ingestion
A 75-year-old female patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Flecainide(dosage: Oral). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Poisoning
  • Exposure Via Ingestion
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Flecainide efficacy: NA.

Poisoning, Exposure Via Ingestion, Completed Suicide
In this report, Flecainide was administered for the following condition: NA.A 38-year-old male consumer from US (weight: NA) started Flecainide treatment (dosage: Oral) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Poisoning
  • Exposure Via Ingestion
  • Completed Suicide
A possible interaction with other drugs could have contributed to this reaction:
  • Ethanol (ethanol) (ethanol) (Oral)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Flecainide treatment could be related to the listed above side effect(s).

Poisoning, Exposure Via Ingestion
This is a report of the following Flecainide side effect(s):
  • Poisoning
  • Exposure Via Ingestion
A 51-year-old male patient from US (weight: NA) presented with the following condition: NA and received a treatment with Flecainide (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Flecainide treatment could be associated with the listed above side effect(s).

Completed Suicide
This Flecainide report was submitted by a 40-year-old male consumer from US (weight: NA). The patient was diagnosed with: NA and Flecainide was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Completed Suicide
Other drugs used simultaneously:
  • Simvastatin (simvastatin) (simvastatin)
  • Sotalol (sotalol)
  • Warfarin (warfarin) (warfarin)
Those unexpected symptoms could be linked to a Flecainide treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Rash, Urticaria, Product Quality Issue
This is a report of a possible correlation between Flecainide use and the following symptoms/side effect(s):
  • Rash
  • Urticaria
  • Product Quality Issue
which could contribute to an assessment of Flecainide risk profile.A 71-year-old female consumer from US (weight: NA) was suffering from atrial fibrillation and was treated with Flecainide (dosage: 300 Mg) starting 1997.Other concurrent medications: NA.

Dizziness, Palpitations, Bradycardia, Hypotension, Atrioventricular Block, Toxicity To Various Agents, Overdose, Syncope
A 82-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Flecainide (dosage: 400 Mg) experienced the following side effect(s):
  • Dizziness
  • Palpitations
  • Bradycardia
  • Hypotension
  • Atrioventricular Block
  • Toxicity To Various Agents
  • Overdose
  • Syncope
The treatment was started on NS. Flecainide was used in combination with the following drugs:
  • Verapamil (verapamil) (verapamil)
  • Warfarin (warfarin) (warfarin)
  • Albuterol Inhaler (salbutamol) (inhalant) (salbutamol)
  • Budesonide And Formoterol Combination Inhaler (formoteroal W/budesonide) (budesonide, Formoterol)
The patient was hospitalized.This report could alert potential Flecainide consumers.

Toxicity To Various Agents
In this report, a 3-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) was affected by a possible Flecainide side effect.The patient was diagnosed with supraventricular tachycardia. After a treatment with Flecainide (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Toxicity To Various Agents
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Flecainide treatment.

Organising Pneumonia
This is a report of a 68-year-old male patient from DE (weight: NA), who used Flecainide (dosage: 50 Mg, Bid) for a treatment of atrial fibrillation. After starting a treatment on Nov 19, 2012, the patient experienced the following side effect(s):
  • Organising Pneumonia
The following drugs could possibly have interacted with the Flecainide treatment
  • Marcumar
  • Metoprolol
  • Tamsulosin (0.4 Mg, Qd)
The patient was hospitalized.Taken together, these observations suggest that a Flecainide treatment could be related to side effect(s), such as Organising Pneumonia.

Mania, Violence-related Symptom
This mania side effect was reported by a physician from US. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: heart rate irregular,ventricular extrasystoles,hypertension. The patient was prescribed Flecainide (dosage: 200 Mg), which was started on 201308. Concurrently used drugs: NA. When starting to take Flecainide the consumer reported the following symptoms:
  • Mania
  • Violence-related Symptom
The patient was hospitalized. These side effects may potentially be related to Flecainide.

Bradycardia, Hypotension, Hypoglycaemia
This is a Flecainide Teva 100mg side effect report of a 76-year-old female patient (weight:NA) from IT, suffering from the following symptoms/conditions: atrial fibrillation,type 2 diabetes mellitus,hypertension, who was treated with Flecainide Teva 100mg (dosage:150 Milligram Daily;, start time: NS), combined with:
  • Amaryl 2mg (2 Milligram Daily;)
  • Blopresid 32mg/25mg (1 Dosage Forms Daily;)
  • Cardura 4mg (4 Milligram Daily; Modified Release Tablet)
  • Lansox 15mg (1 Dosage Forms Daily; Orodispersible Tablet)
  • Coumadin
, and developed a serious reaction and a bradycardia side effect. The patient presented with:
  • Bradycardia
  • Hypotension
  • Hypoglycaemia
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Flecainide Teva 100mg treatment in female patients suffering from atrial fibrillation,type 2 diabetes mellitus,hypertension, resulting in bradycardia.

Syncope, Tachyarrhythmia, Ventricular Tachycardia, Toxicity To Various Agents, Overdose
This report suggests a potential Flecainide syncope side effect(s) that can have serious consequences. A 3-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): supraventricular tachycardia and used Flecainide (dosage: NA) starting NS. Soon after starting Flecainide the patient began experiencing various side effects, including:
  • Syncope
  • Tachyarrhythmia
  • Ventricular Tachycardia
  • Toxicity To Various Agents
  • Overdose
Drugs used concurrently:NA. The patient was hospitalized. Although Flecainide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as syncope, may still occur.

Toxicity To Various Agents
This toxicity to various agents problem was reported by a health professional from US. A 3-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): supraventricular tachycardia.On NS a consumer started treatment with Flecainide Acetate (dosage: Unk). The following drugs/medications were being taken at the same time: NA. When commencing Flecainide Acetate, the patient experienced the following unwanted symptoms /side effects:
  • Toxicity To Various Agents
Although all drugs are carefully tested before they are licensed for use, they carry potential 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.

Tachycardia, Cardiac Arrest, Incorrect Dose Administered
This is a Flecainide Acetate side effect report of a male patient (weight: NA) from US. The patient developed the following symptoms/conditions: supraventricular tachycardia and was treated with Flecainide Acetate (dosage: Every 8 Hours) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Tachycardia
  • Cardiac Arrest
  • Incorrect Dose Administered
This opens a possibility that Flecainide Acetate could cause tachycardia and that some male patients may be more susceptible.

Chest Pain, Product Quality Issue
A 51-year-old female patient (weight: NA) from US with the following symptoms: ventricular extrasystoles,atrial fibrillation started Flecainide treatment (dosage: 200 Mg) on NS. Soon after starting Flecainide treatment, the consumer experienced several side effects, including:
  • Chest Pain
  • Product Quality Issue
. Concurrently used drugs:
  • Digoxin
This finding indicates that some patients can be more vulnerable to developing Flecainide side effects, such as chest pain.

Atrioventricular Block First Degree, Electrocardiogram Qt Prolonged, Blood Potassium Decreased
This atrioventricular block first degree side effect was reported by a physician from US. A 51-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Flecainide (dosage: NA), which was started on NS. Concurrently used drugs:
  • Alprozolam (alprazolam) (alprazolam)
  • Lisinopril (lisinopril) (lisinopril)
  • Aspirin (acetylysalicylic Acid) (acetylsalicylic Acid)
.When starting to take Flecainide the consumer reported symptoms, such as:
  • Atrioventricular Block First Degree
  • Electrocardiogram Qt Prolonged
  • Blood Potassium Decreased
These side effects may potentially be related to Flecainide. The patient was hospitalized.

Accidental Overdose, Toxicity To Various Agents
This is a report of a male patient (weight: NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: supraventricular tachycardia, who was treated with Flecainide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Accidental Overdose
  • Toxicity To Various Agents
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Flecainide treatment in male patients, resulting in accidental overdose side effect.

Lethargy, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Accidental Overdose, Product Label Issue
This report suggests a potential Flecainide Lethargy, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Accidental Overdose, Product Label Issue side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: supraventricular tachycardia and used Flecainide (dosage: NA) starting NS. Soon after starting Flecainide the patient began experiencing various side effects, including:
  • Lethargy
  • Cardiac Arrest Neonatal
  • Tachycardia
  • Toxicity To Various Agents
  • Accidental Overdose
  • Product Label Issue
Drugs used concurrently:
  • Atropine
  • Adenosine
  • Esmolol
The patient was hospitalized. Although Flecainide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as lethargy, may still occur.

Neutropenia, Transient Ischaemic Attack, White Blood Cell Count Decreased
This Neutropenia, Transient Ischaemic Attack, White Blood Cell Count Decreased problem was reported by a health professional from AU. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Flecainide (dosage: NA). The following drugs were being taken at the same time:
  • Omeprazole
  • Metoprolol
When commencing Flecainide, the patient experienced the following unwanted symptoms/side effects:
  • Neutropenia
  • Transient Ischaemic Attack
  • White Blood Cell Count Decreased
The 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 neutropenia, may become evident only after a product is in use by the general population.

Supraventricular Tachycardia, Malaise, Apnoea, Hypotonia, Agitation, Confusional State, Posture Abnormal, Electrocardiogram Qrs Complex Prolonged
This is a report of a 8-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: supraventricular tachycardia and was treated with Flecainide (dosage: NA) starting 200710. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Supraventricular Tachycardia
  • Malaise
  • Apnoea
  • Hypotonia
  • Agitation
  • Confusional State
  • Posture Abnormal
  • Electrocardiogram Qrs Complex Prolonged
This opens a possibility that Flecainide treatment could cause the above reactions, including supraventricular tachycardia, and some male subjects may be more susceptible.

Accidental Overdose, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Product Label Issue
A male patient (weight: NA) from US with the following symptoms/conditions: supraventricular tachycardia started Flecainide treatment (dosage: 8mg Every 8h (instead Of Prescribed Dosage)) on NS. Soon after starting Flecainide treatment, the subject experienced various side effects, including:
  • Accidental Overdose
  • Cardiac Arrest Neonatal
  • Tachycardia
  • Toxicity To Various Agents
  • Product Label Issue
Concurrently used drugs:
  • Atropine (0.1mg)
  • Adenosine
  • Esmolol
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Flecainide.

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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.


    Discuss Flecainide Side Effects

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    Flecainide Safety Alerts, Active Ingredients, Usage Information

    NDC0054-0010
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameFlecainide Acetate
    Nameflecainide acetate
    Dosage FormTABLET
    RouteORAL
    On market since20030114
    LabelerRoxane Laboratories, Inc.
    Active Ingredient(s)FLECAINIDE ACETATE
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassAntiarrhythmic [EPC]

    More About Flecainide

    Side Effects reported to FDA: 443

    Flecainide safety alerts: No

    Reported deaths: 42

    Reported hospitalizations: 195

    Latest Flecainide clinical trials