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Flecainide Side Effects

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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.

Flecainide Side Effects Reported to FDA



Flecainide Side Effect Report#9999049
Ventricular Tachycardia, Overdose
This is a report of a 72-year-old female patient (weight: NA) from FR, suffering from the following health 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): Ventricular Tachycardia, Overdose 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.
Flecainide Side Effect Report#9940597
Atrioventricular Block First Degree, Hypotension, Sopor
This report suggests a potential Flecainide Acetate Atrioventricular Block First Degree 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. After starting Flecainide Acetate the patient began experiencing various side effects, including: Atrioventricular Block First Degree, Hypotension, SoporAdditional 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.
Flecainide Side Effect Report#9928767
Left Ventricular Failure, Left Ventricular Hypertrophy, Systolic Dysfunction, Dyspnoea, Ejection Fraction Decreased, Ventricular Tachycardia, Overdose
This Left Ventricular Failure 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 using Flecainide, the patient experienced the following unwanted symptoms/side effects: Left Ventricular Failure, Left Ventricular Hypertrophy, Systolic Dysfunction, Dyspnoea, Ejection Fraction Decreased, Ventricular Tachycardia, OverdoseThe 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.
Flecainide Side Effect Report#9891584
Poisoning, Completed Suicide, Exposure Via Ingestion
This Poisoning side effect was reported by a physician from US. A 31-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Flecainide (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Quetiapine
  • Citalopram (P.o.)
  • Oxycodone
  • Alprazolam
.After starting to take Flecainide the consumer reported adverse symptoms, such as: Poisoning, Completed Suicide, Exposure Via IngestionThese side effects may potentially be related to Flecainide.
Flecainide Side Effect Report#9890807
Product Quality Issue
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Flecainide (dosage: 300 Mg, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Flecainide treatment in male patients, resulting in Product Quality Issue side effect.
Flecainide Side Effect Report#9888966
Poisoning, Exposure Via Ingestion
This report suggests a potential Flecainide Poisoning side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Flecainide (dosage: Oral) starting NS. After starting Flecainide the patient began experiencing various side effects, including: Poisoning, Exposure Via IngestionAdditional drugs used concurrently: NA. Although Flecainide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Flecainide Side Effect Report#9888916
Poisoning, Exposure Via Ingestion, Completed Suicide
This Poisoning problem was reported by a health professional from US. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Flecainide (dosage: Oral). The following drugs were being taken at the same time:
  • Ethanol (ethanol) (ethanol) (Oral)
When using Flecainide, the patient experienced the following unwanted symptoms/side effects: Poisoning, Exposure Via Ingestion, Completed SuicideAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poisoning, may become evident only after a product is in use by the general population.
Flecainide Side Effect Report#9888665
Poisoning, Exposure Via Ingestion
This Poisoning side effect was reported by a health professional from US. A 51-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Flecainide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Flecainide the consumer reported adverse symptoms, such as: Poisoning, Exposure Via IngestionThese side effects may potentially be related to Flecainide.
Flecainide Side Effect Report#9888647
Completed Suicide
This is a report of a 40-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Flecainide (dosage: NA, start time: NS), combined with:
  • Simvastatin (simvastatin) (simvastatin)
  • Sotalol (sotalol)
  • Warfarin (warfarin) (warfarin)
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Flecainide treatment in male patients, resulting in Completed Suicide side effect.
Flecainide Side Effect Report#9739466
Rash, Urticaria, Product Quality Issue
This report suggests a potential Flecainide Rash side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation and used Flecainide (dosage: 300 Mg) starting 1997. After starting Flecainide the patient began experiencing various side effects, including: Rash, Urticaria, Product Quality IssueAdditional drugs used concurrently: NA. Although Flecainide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Flecainide Side Effect Report#9725236
Dizziness, Palpitations, Bradycardia, Hypotension, Atrioventricular Block, Toxicity To Various Agents, Overdose, Syncope
This Dizziness problem was reported by a health professional from US. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Flecainide (dosage: 400 Mg). The following drugs were being taken at the same time:
  • Verapamil (verapamil) (verapamil)
  • Warfarin (warfarin) (warfarin)
  • Albuterol Inhaler (salbutamol) (inhalant) (salbutamol)
  • Budesonide And Formoterol Combination Inhaler (formoteroal W/budesonide) (budesonide, Formoterol)
When using Flecainide, the patient experienced the following unwanted symptoms/side effects: Dizziness, Palpitations, Bradycardia, Hypotension, Atrioventricular Block, Toxicity To Various Agents, Overdose, SyncopeThe 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 Dizziness, may become evident only after a product is in use by the general population.
Flecainide Side Effect Report#9693063
Toxicity To Various Agents
This Toxicity To Various Agents side effect was reported by a health professional from Country Not Specified. A 3-year-old male patient (weight:NA) experienced the following symptoms/conditions: supraventricular tachycardia.The patient was prescribed Flecainide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Flecainide the consumer reported adverse symptoms, such as: Toxicity To Various AgentsThese side effects may potentially be related to Flecainide. The patient was hospitalized.
Flecainide Side Effect Report#9688659
Organising Pneumonia
This is a report of a 68-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Flecainide (dosage: 50 Mg, Bid, start time:
Nov 19, 2012), combined with:
  • Marcumar
  • Metoprolol
  • Tamsulosin (0.4 Mg, Qd)
and developed a serious reaction and side effect(s): Organising Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Flecainide treatment in male patients, resulting in Organising Pneumonia side effect. The patient was hospitalized.
Flecainide Side Effect Report#9685582
Mania, Violence-related Symptom
This report suggests a potential Flecainide Mania side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: heart rate irregular,ventricular extrasystoles,hypertension and used Flecainide (dosage: 200 Mg) starting 201308. After starting Flecainide the patient began experiencing various side effects, including: Mania, Violence-related SymptomAdditional drugs used concurrently: NA.The patient was hospitalized. Although Flecainide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mania, may still occur.
Flecainide Side Effect Report#9681300
Bradycardia, Hypotension, Hypoglycaemia
This Bradycardia problem was reported by a physician from IT. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,type 2 diabetes mellitus,hypertension. On NS this consumer started treatment with Flecainide Teva 100mg (dosage: 150 Milligram Daily;). The following drugs were being taken at the same time:
  • 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
When using Flecainide Teva 100mg, the patient experienced the following unwanted symptoms/side effects: Bradycardia, Hypotension, HypoglycaemiaThe 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 Bradycardia, may become evident only after a product is in use by the general population.
Flecainide Side Effect Report#9675819
Syncope, Tachyarrhythmia, Ventricular Tachycardia, Toxicity To Various Agents, Overdose
This Syncope side effect was reported by a health professional from US. A 3-year-old male patient (weight:NA) experienced the following symptoms/conditions: supraventricular tachycardia.The patient was prescribed Flecainide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Flecainide the consumer reported adverse symptoms, such as: Syncope, Tachyarrhythmia, Ventricular Tachycardia, Toxicity To Various Agents, OverdoseThese side effects may potentially be related to Flecainide. The patient was hospitalized.
Flecainide Side Effect Report#9674666
Toxicity To Various Agents
This is a report of a 3-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: supraventricular tachycardia, who was treated with Flecainide Acetate (dosage: Unk, start time: NS), combined with: NA. 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 Flecainide Acetate treatment in male patients, resulting in Toxicity To Various Agents side effect.
Flecainide Side Effect Report#9627102
Tachycardia, Cardiac Arrest, Incorrect Dose Administered
This report suggests a potential Flecainide Acetate Tachycardia 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 Acetate (dosage: Every 8 Hours) starting NS. After starting Flecainide Acetate the patient began experiencing various side effects, including: Tachycardia, Cardiac Arrest, Incorrect Dose AdministeredAdditional drugs used concurrently: NA. Although Flecainide Acetate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tachycardia, may still occur.
Flecainide Side Effect Report#9609293
Chest Pain, Product Quality Issue
This Chest Pain problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ventricular extrasystoles,atrial fibrillation. On NS this consumer started treatment with Flecainide (dosage: 200 Mg). The following drugs were being taken at the same time:
  • Digoxin
When using Flecainide, the patient experienced the following unwanted symptoms/side effects: Chest Pain, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chest Pain, may become evident only after a product is in use by the general population.
Flecainide Side Effect Report#9602797
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 (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Alprozolam (alprazolam) (alprazolam)
  • Lisinopril (lisinopril) (lisinopril)
  • Aspirin (acetylysalicylic Acid) (acetylsalicylic Acid)
.After starting to take Flecainide the consumer reported adverse symptoms, such as: Atrioventricular Block First Degree, Electrocardiogram Qt Prolonged, Blood Potassium DecreasedThese side effects may potentially be related to Flecainide. The patient was hospitalized.
Flecainide Side Effect Report#9508430
Accidental Overdose, Toxicity To Various Agents
This is a report of a male patient (weight: NA) from Country Not Specified, suffering from the following health 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): Accidental Overdose, Toxicity To Various Agents 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.
Flecainide Side Effect Report#9498809
Lethargy, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Accidental Overdose, Product Label Issue
This report suggests a potential Flecainide Lethargy 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. After starting Flecainide the patient began experiencing various side effects, including: Lethargy, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Accidental Overdose, Product Label IssueAdditional 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.
Flecainide Side Effect Report#9494081
Neutropenia, Transient Ischaemic Attack, White Blood Cell Count Decreased
This Neutropenia 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 using Flecainide, the patient experienced the following unwanted symptoms/side effects: Neutropenia, Transient Ischaemic Attack, White Blood Cell Count DecreasedThe 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.
Flecainide Side Effect Report#9491922
Supraventricular Tachycardia, Malaise, Apnoea, Hypotonia, Agitation, Confusional State, Posture Abnormal, Electrocardiogram Qrs Complex Prolonged
This Supraventricular Tachycardia side effect was reported by a health professional from GB. A 8-year-old male patient (weight:NA) experienced the following symptoms/conditions: supraventricular tachycardia.The patient was prescribed Flecainide (drug dosage: NA), which was initiated on 200710. Concurrently used drugs: NA..After starting to take Flecainide the consumer reported adverse symptoms, such as: Supraventricular Tachycardia, Malaise, Apnoea, Hypotonia, Agitation, Confusional State, Posture Abnormal, Electrocardiogram Qrs Complex ProlongedThese side effects may potentially be related to Flecainide.
Flecainide Side Effect Report#9490079
Accidental Overdose, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Product Label Issue
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: supraventricular tachycardia, who was treated with Flecainide (dosage: 8mg Every 8h (instead Of Prescribed Dosage), start time: NS), combined with:
  • Atropine (0.1mg)
  • Adenosine
  • Esmolol
and developed a serious reaction and side effect(s): Accidental Overdose, Cardiac Arrest Neonatal, Tachycardia, Toxicity To Various Agents, Product Label Issue 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. The patient was hospitalized.


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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.

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Track Your Side Effects

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.

    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.

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    Discuss Flecainide Side Effects

    Did You Have a Flecainide Side Effect?

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    Yes, Minor
    No

    How Effective is Flecainide for You?

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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