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 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 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 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 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 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 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 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 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 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 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 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 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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