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Tricor (Fenofibrate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tricor (Fenofibrate) 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 (175)
Death (6)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Myalgia (17)Arthralgia (17)Malaise (16)Drug Ineffective (13)Muscular Weakness (13)Pruritus (12)Muscle Spasms (12)Hepatic Enzyme Increased (12)Dizziness (11)Pain in Extremity (11)Thrombosis (9)Fatigue (9)

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

Possible Tricor side effects in female

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

Patient: female, weighing 62.5 kg (137.5 pounds)

Reactions: Chromaturia, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Amlodipine Besylate



Possible Tricor side effects in 62 year old female

Reported by a physician from Japan on 2012-08-10

Patient: 62 year old female

Reactions: Chromaturia, Ocular Icterus, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Amlodipine Besylate



Possible Tricor side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Celebrex

Nasonex
    Dosage: unk

Tricor

Vioxx

Welchol
    Dosage: 625 mg, bid
    Administration route: Oral



Possible Tricor side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 64 year old female

Reactions: Breast Cancer, Muscular Weakness, Muscle Spasms

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

Aspirin
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Indication: Product Used FOR Unknown Indication

Dyrenium (Triamterene)
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Tricor
    Indication: Product Used FOR Unknown Indication

Trilipix
    Indication: Product Used FOR Unknown Indication



Possible Tricor side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Breast Cancer, Muscular Weakness, Muscle Spasms, Discomfort

Drug(s) suspected as cause:
Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Aspirin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Dyrenium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Tricor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Trilipix
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Tricor side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient:

Reactions: Myalgia, Muscular Weakness, Musculoskeletal Stiffness

Drug(s) suspected as cause:
Crestor

Lipitor

Lyrica
    Dosage: 75 mg, bid
    Administration route: Oral

Paxil

Pravachol

Tricor

Zocor
    Administration route: Oral

Other drugs received by patient: Minocycline HCL; Cymbalta; Cyanocobalamin; Calcium (Unspecified); Ascorbic Acid; Savella; Metformin HCL; Vitamins (Unspecified); Sotalol Hydrochloride; Glyburide; Lovaza; Januvia; Lantus; Zetia; Losartan Potassium; Ciprofloxacin; Aspirin



Possible Tricor side effects in female

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

Patient: female, weighing 133.9 kg (294.6 pounds)

Reactions: LIP Swelling, Tongue Discolouration, Pruritus, Swelling Face, Skin Exfoliation, Pain, Rash, Rash Pruritic, Burning Sensation, Swelling

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Cholesterol
    End date: 2011-08-04

Tricor
    Indication: Blood Cholesterol
    Start date: 2008-01-01

Other drugs received by patient: Vytorin; Progesterone; Vitamin D; Dhea / Preg; Metformin Hydrochloride; A-Thyroid; Zoloft



Possible Tricor side effects in male

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

Patient: male, weighing 104.4 kg (229.7 pounds)

Reactions: Flushing, Neck Pain, Musculoskeletal Pain

Drug(s) suspected as cause:
Niaspan
    Dosage: at bedtime
    Indication: High Density Lipoprotein Decreased
    Start date: 2010-01-01

Tricor
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Tricor; Ibuprofen (Advil); Bystolic; Aspirin



Possible Tricor side effects in male

Reported by a physician from United States on 2012-08-02

Patient: male, weighing 87.4 kg (192.2 pounds)

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Crestor
    Dosage: unk

Lipitor
    Dosage: unk
    End date: 2008-08-01

Tricor
    Dosage: unk

Zocor
    Dosage: unk



Possible Tricor side effects in male

Reported by a physician from United States on 2012-08-02

Patient: male, weighing 90.3 kg (198.8 pounds)

Reactions: Asthma, Food Allergy

Drug(s) suspected as cause:
Multi-Vitamin
    Indication: Product Used FOR Unknown Indication

Tricor
    Indication: Blood Triglycerides Increased
    Start date: 2011-08-19
    End date: 2012-05-11

Other drugs received by patient: Albuterol; Singulair; Asmanex Twisthaler; Loratadine



Possible Tricor side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Breast Cancer, Muscular Weakness, Muscle Spasms, Discomfort

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

Aspirin
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Indication: Product Used FOR Unknown Indication

Dyrenium
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Tricor
    Indication: Product Used FOR Unknown Indication

Trilipix
    Indication: Product Used FOR Unknown Indication



Possible Tricor side effects in

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

Patient:

Reactions: Osteoarthritis, Blood Triglycerides Increased, Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

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

Tricor

Zocor
    Administration route: Oral



Possible Tricor side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female

Reactions: Cardiospasm, Breast Cancer Female, Muscular Weakness, Discomfort, Muscle Spasms, Laryngospasm

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: unk

Amlodipine Besylate
    Dosage: unk

Carvedilol
    Dosage: unk

Dyrenium
    Dosage: unk

Spironolactone
    Dosage: unk

Tricor
    Dosage: unk

Trilipix
    Dosage: unk



Possible Tricor side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: 66 year old female

Reactions: Muscular Weakness, Oropharyngeal Spasm, Cardiac Disorder, Discomfort, Muscle Spasms

Drug(s) suspected as cause:
Amlodipine

Aspirin

Carvedilol

Dyrenium

Spironolactone

Tricor

Trilipix



Possible Tricor side effects in

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient:

Reactions: Myalgia, Asthenia

Drug(s) suspected as cause:
Tricor

Zocor
    Administration route: Oral

Other drugs received by patient: Actos; Neurontin; Lantus; Lisinopril; Celebrex; Gemfibrozil; Novolog; Metformin Hydrochloride



Possible Tricor side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 65 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Coumadin
    Indication: Factor V Leiden Mutation

Tricor
    Indication: Factor V Leiden Mutation



Possible Tricor side effects in male

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

Patient: male, weighing 87.4 kg (192.2 pounds)

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Crestor
    Dosage: unk

Lipitor
    Dosage: unk

Tricor
    Dosage: unk

Zocor
    Dosage: unk



Possible Tricor side effects in male

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

Patient: male, weighing 90.3 kg (198.8 pounds)

Reactions: Asthma, Food Allergy

Drug(s) suspected as cause:
Multi-Vitamin
    Indication: Product Used FOR Unknown Indication

Tricor
    Indication: Blood Triglycerides Increased
    End date: 2012-05-07



Possible Tricor side effects in male

Reported by a physician from United States on 2012-07-10

Patient: male, weighing 93.1 kg (204.8 pounds)

Reactions: Glossodynia, Dysphagia, Wrong Technique in Drug Usage Process, Epiglottic Carcinoma, Tablet Physical Issue, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tricor
    Indication: Blood Cholesterol
    Start date: 2004-01-01

Tricor
    Indication: Hyperlipidaemia

Other drugs received by patient: Coumadin; Coumadin; Metoprolol Succinate; Lisinopril; Vitamin D



Possible Tricor side effects in male

Reported by a physician from United States on 2012-06-29

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Crestor
    Dosage: unk

Lipitor
    Dosage: unk

Tricor
    Dosage: unk

Zocor
    Dosage: unk



Possible Tricor side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: 52 year old female

Reactions: Back Pain, Pain in Extremity, Chromaturia, Product Adhesion Issue, Product Physical Issue, Liver Disorder, Hepatic Enzyme Increased, Activities of Daily Living Impaired, Arthralgia, Dysuria

Drug(s) suspected as cause:
Lovaza
    Indication: Blood Triglycerides Increased

Lovaza
    Dosage: two tablets of unknown dose two times a day
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Pravastatin
    Dosage: daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-07-01

Premarin
    Dosage: 0.625 mg/g, daily 3 weeks on 1 week off
    Indication: Menopause
    Start date: 2012-02-01

Premarin
    Indication: Oestradiol Decreased

Tricor
    Dosage: daily
    Indication: Blood Cholesterol Increased
    End date: 2011-07-01

Other drugs received by patient: Estrogens Conjugated



Possible Tricor side effects in 38 year old male

Reported by a physician from Japan on 2012-06-20

Patient: 38 year old male

Reactions: Drug-Induced Liver Injury

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Allopurinol



Possible Tricor side effects in 73 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-06-20

Patient: 73 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Type 2 Diabetes Mellitus, Muscular Weakness, Paraesthesia, Fatigue, Malaise, Activities of Daily Living Impaired, Dizziness, Blood Glucose Increased

Drug(s) suspected as cause:
Tricor
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2012-04-24
    End date: 2012-04-30

Tricor
    Indication: Hypertriglyceridaemia

Other drugs received by patient: Ismn; Furosemide; Atorvox; Statin; Nebivolol HCL; Folic Acid; Plendil; Kalij Klorid Jadran



Possible Tricor side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: male, weighing 93.1 kg (204.8 pounds)

Reactions: Glossodynia, Wrong Technique in Drug Usage Process, Dysphagia, Epiglottic Carcinoma, Tablet Physical Issue, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Coumadin; Lisinopril; Vitamin D; Metoprolol Succinate; Coumadin



Possible Tricor side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Crestor
    Dosage: unk

Lipitor
    Dosage: unk

Tricor
    Dosage: unk

Zocor
    Dosage: unk



Possible Tricor side effects in female

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

Patient: female, weighing 79.4 kg (174.6 pounds)

Reactions: Neuropathy Peripheral, Sneezing

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

Multi-Vitamins
    Indication: Product Used FOR Unknown Indication

Procrit
    Dosage: every 2 weeks as needed
    Indication: Nephrogenic Anaemia

Tramadol HCL
    Indication: Pain

Tricor
    Indication: Blood Triglycerides Increased



Possible Tricor side effects in 73 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-06-08

Patient: 73 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Malaise, Fatigue, Type 2 Diabetes Mellitus, Activities of Daily Living Impaired, Dizziness, Muscular Weakness, Blood Glucose Increased, Paraesthesia

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Statin; Plendil; Kalij Klorid Jadran; Furosemide; Atorvox; Folic Acid; Nebivolol HCL; Ismn



Possible Tricor side effects in 73 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-06-07

Patient: 73 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Type 2 Diabetes Mellitus, Muscular Weakness, Paraesthesia, Fatigue, Malaise, Activities of Daily Living Impaired, Dizziness, Blood Glucose Increased

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Nebivolol HCL; Folic Acid; Statin; Ismn; Atorvox; Plendil; Kalij Klorid Jadran; Furosemide



Possible Tricor side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Celebrex
    Dosage: unk

Nasonex
    Dosage: unk

Tricor
    Dosage: unk

Vioxx
    Dosage: unk

Welchol
    Dosage: 625 mg, 2x/day
    Administration route: Oral



Possible Tricor side effects in 73 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-06-04

Patient: 73 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Fatigue, Malaise, Activities of Daily Living Impaired, Muscular Weakness, Dizziness, Muscle Spasms, Paraesthesia

Drug(s) suspected as cause:
Tricor

Other drugs received by patient: Ismn; Folic Acid; Furosemide; Kalij Klorid Jadran; Nebivolol HCL; Statin; Plendil; Atorvox

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