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Plendil (Felodipine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Plendil (Felodipine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (27)
Disability (1)

Reports by Reaction Type

Atrial Fibrillation (5)Drug Ineffective (4)Drug Hypersensitivity (3)Cerebrovascular Accident (3)Cardiac Disorder (2)Cerebral Haemorrhage (2)ECG Signs of Myocardial Ischaemia (2)Anaphylactoid Reaction (2)Acute Coronary Syndrome (2)Myocardial Infarction (2)White Blood Cell Count Decreased (2)Cardiac Enzymes Increased (2)

Possible Plendil side effects in female

Reported by a physician from China on 2012-08-27

Patient: female, weighing 55.8 kg (122.8 pounds)

Reactions: Psychotic Disorder

Drug(s) suspected as cause:
Plendil



Possible Plendil side effects in male

Reported by a physician from China on 2012-08-27

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Atrioventricular Block Complete, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Irbesartan



Possible Plendil side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 49 year old female

Reactions: Mental Impairment, Cerebrovascular Accident, Cerebral Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Toprol-XL
    Administration route: Oral

Plendil
    Administration route: Oral



Possible Plendil side effects in male

Reported by a physician from Lebanon on 2012-08-20

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Atrial Fibrillation, Muscular Weakness, Polyuria, Asthenia, Arrhythmia, Hypokalaemia, Nephropathy

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Plendil



Possible Plendil side effects in male

Reported by a physician from China on 2012-08-15

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Gingival Pain, Gingival Hyperplasia, Brain Stem Infarction, Gingival Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil



Possible Plendil side effects in male

Reported by a consumer/non-health professional from Sweden on 2012-08-15

Patient: male, weighing 77.0 kg (169.4 pounds)

Reactions: Generalised Erythema, Drug Ineffective, Atrial Fibrillation, Colon Neoplasm

Drug(s) suspected as cause:
Plendil
    Administration route: Oral
    Indication: Hypertension

Plendil
    Administration route: Oral

Other drugs received by patient: Avastin; Metoprolol Tartrate



Possible Plendil side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 77 year old female

Reactions: Concussion, Atrial Fibrillation, Intentional Drug Misuse, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil
    Administration route: Oral
    Start date: 2004-06-29

Toprol-XL
    Administration route: Oral
    Start date: 2004-06-29

Toprol-XL
    Dosage: taking half of the tablet
    Administration route: Oral



Possible Plendil side effects in female

Reported by a physician from China on 2012-07-31

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Plendil



Possible Plendil side effects in 73 year old female

Reported by a physician from Canada on 2012-07-25

Patient: 73 year old female

Reactions: Fatigue, Angina Pectoris, Post Procedural Discomfort

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Diclofenac; Metoprolol Succinate; Simvastatin; Metoprolol Succinate; Metoprolol Succinate; Ezetimibe



Possible Plendil side effects in 46 year old female

Reported by a physician from China on 2012-07-25

Patient: 46 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Plendil



Possible Plendil side effects in 75 year old female

Reported by a physician from United States on 2012-07-17

Patient: 75 year old female, weighing 65.3 kg (143.7 pounds)

Reactions: Off Label Use, Arthralgia

Drug(s) suspected as cause:
Faslodex

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Faslodex
    Indication: Breast Cancer

Plendil
    Administration route: Oral
    Indication: Blood Pressure Abnormal

Other drugs received by patient: Simvastatin; Pradaxa; Multaq; Boniva



Possible Plendil side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 63 year old female

Reactions: Aphagia, Gingival Pain, Gingival Swelling, Delusion

Drug(s) suspected as cause:
Toprol-XL
    Administration route: Oral

Plendil
    Administration route: Oral



Possible Plendil side effects in 72 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-05-07

Patient: 72 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Drug Intolerance, Erythema, Discomfort

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Crestor; Xyzal; Travoprost and Timolol; Famosan; Atenolol



Possible Plendil side effects in female

Reported by a physician from United States on 2012-04-30

Patient: female

Reactions: Drug Ineffective, Drug Hypersensitivity, Cardiac Enzymes Increased, Cardiac Disorder, ECG Signs of Myocardial Ischaemia, Ejection Fraction Decreased, Myocardial Infarction, Acute Coronary Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil
    Administration route: Oral

Lisinopril and Hydrochlorothiazide
    Administration route: Oral

Toprol-XL
    Administration route: Oral
    Indication: Acute Coronary Syndrome

Other drugs received by patient: Alprazolam; Plavix; Aspirin; Aspirin; Levothyroxine Sodium; COQ 10; Lipitor; Zantac; Lutein; Glipizide; Lucopene; Triamterene and Hydrochlorothiazide



Possible Plendil side effects in 74 year old female

Reported by a consumer/non-health professional from China on 2012-04-19

Patient: 74 year old female

Reactions: White Blood Cell Count Decreased, Nasopharyngitis, Anal Prolapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cephalosporin

Plendil
    Administration route: Oral
    Start date: 2009-01-01

Azithromycin

Plendil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01



Possible Plendil side effects in 74 year old male

Reported by a consumer/non-health professional from China on 2012-04-16

Patient: 74 year old male

Reactions: White Blood Cell Count Decreased, Rectal Prolapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01
    End date: 2008-01-01

Azithromycin

Plendil
    Administration route: Oral
    Start date: 2009-01-01

Cephalosporin



Possible Plendil side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Serbia on 2012-04-02

Patient: 67 year old female

Reactions: Hypothermia

Drug(s) suspected as cause:
Plendil
    Administration route: Oral

Plendil
    Administration route: Oral



Possible Plendil side effects in female

Reported by a individual with unspecified qualification from United States on 2012-03-19

Patient: female

Reactions: Drug Ineffective, ECG Signs of Myocardial Ischaemia, Cardiac Enzymes Increased, Ejection Fraction Decreased, Drug Hypersensitivity, Myocardial Infarction, Acute Coronary Syndrome, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Toprol-XL
    Administration route: Oral
    Indication: Acute Coronary Syndrome

Lisinopril and Hydrochlorothiazide
    Administration route: Oral

Plendil
    Administration route: Oral

Other drugs received by patient: Lipitor; Triamterene and Hydrochlorothiazide; Plavix; Alprazolam; Levothyroxine Sodium; Aspirin; Lutein; Lucopene; COQ 10; Aspirin; Glipizide; Zantac



Possible Plendil side effects in 50 year old female

Reported by a physician from South Africa on 2012-03-01

Patient: 50 year old female

Reactions: Flushing, Anxiety, Palpitations, Menopausal Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Lopressor



Possible Plendil side effects in

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient:

Reactions: Psychomotor Hyperactivity, Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Plendil
    Administration route: Oral
    Indication: Hypertension

Inderal
    Administration route: Oral

Other drugs received by patient: Alprazolam



Possible Plendil side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2011-12-02

Patient: 64 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Blood Pressure Increased, Colonic Polyp, Drug Ineffective, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avalide
    Dosage: over 5 years might be 10 years also authorization no:20-758;
    Start date: 2008-01-01

Plendil



Possible Plendil side effects in 76 year old male

Reported by a physician from Croatia (Local Name: Hrvatska) on 2011-11-09

Patient: 76 year old male

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Plendil
    Administration route: Oral
    Start date: 2011-06-01

Plendil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2011-06-01

Other drugs received by patient: Simvastatin; Losartan Potassium and Hydrochlorothiazide; Physiotens; Cardiopirin



Possible Plendil side effects in 71 year old male

Reported by a physician from Costa Rica on 2011-11-09

Patient: 71 year old male

Reactions: Syncope, Orthostatic Hypotension, Loss of Consciousness

Drug(s) suspected as cause:
Atacand
    Administration route: Oral
    Indication: Systolic Hypertension
    Start date: 2009-01-01

Plendil
    Administration route: Oral
    Indication: Systolic Hypertension
    Start date: 2011-04-01
    End date: 2011-10-21



Possible Plendil side effects in 79 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2011-11-09

Patient: 79 year old female

Reactions: Bradyarrhythmia, Atrial Fibrillation

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Novolog MIX 70 / 30; Fursemid; Glucophage



Possible Plendil side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: 48 year old female

Reactions: Mental Impairment, Cerebrovascular Accident, Cerebral Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Toprol-XL



Possible Plendil side effects in male

Reported by a physician from Nigeria on 2011-10-20

Patient: male

Reactions: Restlessness, Headache

Drug(s) suspected as cause:
Plendil

Other drugs received by patient: Haemactin



Possible Plendil side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 47 year old female

Reactions: Asthma, Drug Hypersensitivity, Oedema Peripheral, Rash

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Zomig
    Indication: Migraine

Plendil
    Administration route: Oral

Symbicort
    Dosage: 160/4.5 mcg twp puffs twice daily
    Start date: 2010-05-18

Other drugs received by patient: Lopressor; Multi-Vitamin; Lasix; Levaquin; Medrol; Protonix; Lasix; Zovirzx; Lortab; Diovan; Protonix; Zocor; Benadryl; Albuterol; Mylanta; Loratadine; Prilosec; Duoneb; Metolazone

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