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Ranexa (Ranolazine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ranexa (Ranolazine) 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 (62)
Death (9)
Life Threatening Events (3)

Reports by Reaction Type

Rhabdomyolysis (7)Drug Interaction (6)Chest Pain (6)Renal Failure Acute (6)Syncope (6)Confusional State (5)Death (5)Nausea (5)Asthenia (5)Transaminases Increased (4)Dizziness (4)Vomiting (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Ranexa (Ranolazine). For a complete list or a specific selection of reports, please use the links above.

Possible Ranexa side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Device Issue

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Nephrolithiasis, Fatigue, Chromaturia, Amphetamines Positive, Vision Blurred, Unevaluable Event, Urine Odour Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Nephrolithiasis, Fatigue, Amphetamines Positive, Vision Blurred, Chromaturia, Urine Odour Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in 76 year old male

Reported by a physician from United States on 2012-08-20

Patient: 76 year old male

Reactions: Haemoglobin Decreased, Economic Problem, Inappropriate Schedule of Drug Administration, Myocardial Infarction, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa
    Dosage: 500 mg, unk
    Indication: Angina Pectoris

Ranexa
    Dosage: 500 mg, bid
    Administration route: Oral
    Start date: 2011-11-01

Other drugs received by patient: Spironolactone; Nitrates; Benazepril Hydrochloride; Zetia; Imdur; Crestor; Prednisone; Flomax; Coreg



Possible Ranexa side effects in female

Reported by a pharmacist from United States on 2012-08-14

Patient: female

Reactions: Renal Impairment

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in

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

Patient:

Reactions: Abnormal Dreams, Confusional State, Dizziness, Fall, Asthenia

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 61.3 kg (134.8 pounds)

Reactions: Flushing, Myalgia, Nausea, Headache, Constipation, Asthenia, Tremor

Drug(s) suspected as cause:
Niaspan
    Indication: High Density Lipoprotein Increased

Niaspan
    Dosage: 1 in am and 1 at pm, daily
    Indication: Catheterisation Cardiac
    Start date: 2011-09-01
    End date: 2011-09-06

Niaspan
    Indication: Stent Placement

Ranexa
    Dosage: not reported
    Indication: Angina Pectoris
    Start date: 2011-09-01

Other drugs received by patient: Metoprolol Tartrate; Crestor; Singulair; Plavix; Ranexa; Azor; Lasix



Possible Ranexa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 78.1 kg (171.8 pounds)

Reactions: Flushing, Generalised Erythema, Panic Attack, Pain, Hypotension, Feeling Hot

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication

Niaspan

Ranexa
    Indication: Cardiac Disorder

Other drugs received by patient: Carvedilol; Lung Medication; Breathing Inhaler; Breathing Treatments; Potassium; Heart Medication; Neurontin; Altace; Fish OIL; Prilosec



Possible Ranexa side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male

Reactions: Myocardial Infarction, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 50 year old male

Reactions: Electrocardiogram QT Prolonged, Myositis, Hyperkalaemia, Tachycardia, Abasia, Drug Interaction, Coronary Artery Disease, Sedation, Asthenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Methadone Hydrochloride
    Dosage: 20mg 4xday po
    Administration route: Oral
    Indication: Pain

Ranexa
    Dosage: 500mg daily po
    Administration route: Oral
    Indication: Angina Pectoris
    Start date: 2012-05-08
    End date: 2012-05-14



Possible Ranexa side effects in male

Reported by a physician from United States on 2012-07-24

Patient: male

Reactions: Torsade DE Pointes, Syncope

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in male

Reported by a physician from United States on 2012-07-16

Patient: male

Reactions: Torsade DE Pointes, Syncope

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: female

Reactions: Drug Ineffective, Chest Pain, Medication Residue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Sleep Disorder, Blood Cholesterol Increased, Sluggishness

Drug(s) suspected as cause:
Lipitor
    Dosage: 50 mg, 2x/day
    Indication: Blood Cholesterol Increased
    Start date: 2012-02-01
    End date: 2012-05-01

Ranexa
    Dosage: 500 mg, 2x/day
    Indication: Cardiac Disorder
    Start date: 2012-02-01

Other drugs received by patient: Lisinopril; Aspirin; Metoprolol



Possible Ranexa side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: male

Reactions: Chest Pain

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-12

Patient:

Reactions: Intercepted Drug Prescribing Error, Haemorrhage, Medication Error

Drug(s) suspected as cause:
Pradaxa

Ranexa



Possible Ranexa side effects in 67 year old male

Reported by a physician from United States on 2012-06-04

Patient: 67 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Plavix; Vitamin C / 00008001 /; Aspirin; Lisinopril; Atenolol



Possible Ranexa side effects in 43 year old female

Reported by a physician from United States on 2012-06-01

Patient: 43 year old female

Reactions: Rhabdomyolysis, Anaemia, Drug Interaction, Rhinorrhoea, Transaminases Increased, Cough, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Metoprolol Tartrate; Plavix; Aspirin; Bactrim DS; Remeron; Prilosec; Lipitor; Atripla; Nitroglycerin; Lipitor



Possible Ranexa side effects in 67 year old male

Reported by a physician from United States on 2012-05-31

Patient: 67 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Plavix; Atenolol; Vitamin C / 00008001 /; Aspirin; Lisinopril



Possible Ranexa side effects in 69 year old female

Reported by a individual with unspecified qualification from United States on 2012-05-30

Patient: 69 year old female

Reactions: Hypotension, Headache

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Sleep Disorder, Blood Cholesterol Increased, Sluggishness

Drug(s) suspected as cause:
Lipitor
    Dosage: 50 mg, 2x/day
    Indication: Blood Cholesterol Increased
    Start date: 2012-02-01
    End date: 2012-05-01

Ranexa
    Dosage: 500 mg, 2x/day
    Indication: Cardiac Disorder
    Start date: 2012-02-01

Other drugs received by patient: Metoprolol; Lisinopril; Aspirin



Possible Ranexa side effects in 43 year old female

Reported by a physician from United States on 2012-05-04

Patient: 43 year old female

Reactions: Rhabdomyolysis, Anaemia, Drug Interaction, Rhinorrhoea, Transaminases Increased, Chest Pain, Renal Failure Acute, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Aspirin; Lipitor; Plavix; Metoprolol Tartrate; Bactrim DS; Prilosec; Atripla; Lipitor; Remeron; Nitroglycerin



Possible Ranexa side effects in male

Reported by a pharmacist from United States on 2012-04-26

Patient: male

Reactions: Pneumonia Aspiration, Respiratory Failure, Parkinson's Disease, Respiratory Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in 40 year old female

Reported by a physician from United States on 2012-04-24

Patient: 40 year old female

Reactions: Rhabdomyolysis, Dialysis, Chest Pain, Chromaturia, Micturition Frequency Decreased

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Lipitor; Lipitor; Atripla



Possible Ranexa side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: female

Reactions: Blood Pressure Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lopressor

Ranexa

Other drugs received by patient: Celebrex



Possible Ranexa side effects in 71 year old male

Reported by a physician from United States on 2012-04-20

Patient: 71 year old male

Reactions: Angina Pectoris, Dyskinesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Imdur



Possible Ranexa side effects in 75 year old female

Reported by a pharmacist from United States on 2012-04-19

Patient: 75 year old female

Reactions: Blood Glucose Decreased

Drug(s) suspected as cause:
Ranexa
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-01

Ranexa
    Dosage: 1000 mg, unk
    Administration route: Oral
    Start date: 2012-04-01



Possible Ranexa side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19

Patient: female, weighing 842.8 kg (1854.1 pounds)

Reactions: LIP Swelling, Skin Discolouration, LIP Pain

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Aspirin; Furosemide; Digoxin; Ambien; Mucinex; Flonase; Ranexa; Lisinopril; Amlodipine; Replens Gel -Vaginal Lubricant; Allegra; Pepto-Bismol MAX Strength Susp; Ergocalciferol; Gaviscon Susp; Omeprazole; Mineral OIL; Singulair; Percocet-5; Carvedilol; Claritin; Flexeril



Possible Ranexa side effects in male

Reported by a physician from United States on 2012-04-16

Patient: male

Reactions: Confusional State, Azotaemia, Muscle Twitching

Drug(s) suspected as cause:
Ranexa



Possible Ranexa side effects in 40 year old female

Reported by a physician from United States on 2012-04-12

Patient: 40 year old female

Reactions: Rhabdomyolysis, Dialysis, Chest Pain, Chromaturia, Micturition Frequency Decreased

Drug(s) suspected as cause:
Ranexa

Other drugs received by patient: Lipitor; Atripla

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