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Trilipix (Fenofibrate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Trilipix (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 (89)
Death (2)
Disability (1)

Reports by Reaction Type

Blood Triglycerides Increased (8)Upper Respiratory Tract Infection (8)Myalgia (7)Muscle Spasms (7)Vomiting (7)Muscular Weakness (7)Headache (6)Hepatic Enzyme Increased (6)Drug Dose Omission (5)Diabetes Mellitus (5)Drug Ineffective (5)Treatment Noncompliance (5)

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

Possible Trilipix side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 55 year old female

Reactions: Vitamin D Deficiency, Muscle Atrophy, Pain in Extremity, Myocardial Infarction, LOW Density Lipoprotein Increased, Muscle Rupture, Muscle Spasms

Adverse event resulted in: hospitalization

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

Lipitor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lovaza
    Dosage: 4cap per day
    Administration route: Oral
    Indication: Blood Triglycerides Increased
    Start date: 2008-05-01

Pravachol
    Indication: Product Used FOR Unknown Indication

Trilipix
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Metformin HCL; Calcium; Lisinopril; Aspirin; Fenofibrate; Metoprolol; Plavix; Imdur



Possible Trilipix 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 Trilipix 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 Trilipix side effects in female

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

Patient: female

Reactions: Hepatic Enzyme Increased

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-01

Trilipix
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Simvastatin



Possible Trilipix side effects in male

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

Patient: male, weighing 71.3 kg (156.8 pounds)

Reactions: Headache, Cough, Blood Glucose Increased

Drug(s) suspected as cause:
Niaspan
    Indication: High Density Lipoprotein Decreased
    Start date: 2012-03-13

Trilipix
    Indication: Blood Triglycerides Increased
    Start date: 2012-01-01

Other drugs received by patient: Metformin Hydrochloride



Possible Trilipix side effects in male

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

Patient: male, weighing 110.3 kg (242.7 pounds)

Reactions: Gout, Abdominal Pain Upper

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

Trilipix
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Several Other Medications; Vytorin



Possible Trilipix side effects in male

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

Patient: male, weighing 93.1 kg (204.8 pounds)

Reactions: Insomnia, Blood Triglycerides Increased

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

Trilipix
    Dosage: every night
    Indication: Blood Triglycerides Increased
    Start date: 2009-03-01
    End date: 2011-12-01



Possible Trilipix side effects in female

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

Patient: female, weighing 62.7 kg (137.8 pounds)

Reactions: Weight Decreased, Pruritus, Diabetes Mellitus, Hepatic Enzyme Increased, Weight Increased, Burning Sensation, Flushing, Feeling Hot, Blood Glucose Increased

Drug(s) suspected as cause:
Niaspan
    Dosage: at bedtime
    Administration route: Oral
    Indication: LOW Density Lipoprotein Increased

Niaspan
    Dosage: at bedtime
    Administration route: Oral
    Indication: Blood Triglycerides Increased

Trilipix
    Dosage: daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: M.v.i.



Possible Trilipix side effects in female

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

Patient: female

Reactions: Constipation

Drug(s) suspected as cause:
Niaspan
    Dosage: at hour of sleep
    Administration route: Oral
    Indication: Blood Cholesterol

Trilipix
    Dosage: at bedtime
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Amlodipine Besylate; Ergo D Softgel Capsule; Flonase; Lasix; Lostensin; Toprol-XL; Januvia; Fish OIL; Micro-K; Perdium Vegetable Laxative; Ranexa; TMG; Toprol-XL; Vitamin B-12; Actos; Avapro; Gel Based Stool Softener; Levasin; Reclast; Amitiza; Crestor; Dexilant; Cyanocobalamin; Phenergan HCL; Aspirin; Zetia



Possible Trilipix 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 Trilipix side effects in male

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

Patient: male, weighing 108.0 kg (237.6 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Drug Ineffective, Joint Hyperextension, Urinary Tract Infection, Blood Triglycerides Increased, Prostatomegaly, Fall, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2008-02-02

Keflex
    Indication: Urinary Tract Infection
    Start date: 2011-06-01

Trilipix
    Indication: Dyslipidaemia
    End date: 2011-01-01

Other drugs received by patient: Vitamin B-12; Bupropion Hydrochloride; Singulair; Calcium Citrate; Claritin; Asmanex Twisthaler; Proventil-HFA; Allopurinol; Lisinopril; Protonix; Aspirin; Vitamin D; Questran; Lovaza; Multi-Vitamins; Foradil; Tramadol Hydrochloride



Possible Trilipix 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 Trilipix 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 Trilipix side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: 47 year old female

Reactions: Diabetes Mellitus, Diabetic Neuropathy

Drug(s) suspected as cause:
Albuterol
    Dosage: 3 ml, every 4 hours
    Start date: 2011-03-09

Atenolol
    Administration route: Oral
    Start date: 2011-08-18

Benicar HCT
    Dosage: 40-12.5 mg, daily
    Administration route: Oral
    Start date: 2012-03-26

Insulin
    Dosage: as directed
    Start date: 2012-03-16

Meloxicam
    Administration route: Oral
    Start date: 2011-03-22

Nexium
    Administration route: Oral
    Start date: 2012-03-01

Proventil-HFA
    Dosage: 2 puff 4 times a day
    Start date: 2011-05-18

Trilipix
    Administration route: Oral
    Start date: 2011-05-18

Other drugs received by patient: Novolog; Azopt; Systane Ultra; Lumigan; Vimovo; Lyrica; Levemir



Possible Trilipix side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 59 year old male

Reactions: Blood Creatine Phosphokinase Increased, Drug Ineffective, Joint Hyperextension, Urinary Tract Infection, Blood Triglycerides Increased, Fall, Hepatic Enzyme Increased, Prostatomegaly

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2009-03-01

Keflex
    Indication: Urinary Tract Infection
    Start date: 2011-06-01

Trilipix
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-01

Other drugs received by patient: Allopurinol; Questran; Bupropion Hydrochloride; Vitamin D; Asmanex Twisthaler; Foradil; Proventil-HFA; Lovaza; Vitamin B-12; Tramadol HCL; Aspirin; Singulair; Claritin; Multi-Vitamins; Calcium Citrate; Lisinopril; Protonix



Possible Trilipix side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26

Patient: female, weighing 58.1 kg (127.8 pounds)

Reactions: Abdominal Pain, Vomiting, Blood Potassium Decreased, Upper Respiratory Tract Infection, Dehydration, Colitis, Pancreatitis, Cholecystitis, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix

Other drugs received by patient: Aspirin; Welchol; Lasix; Magnesium Sulfate; Benicar; Vitamin D; Calcium; Paxil; Trazodone HCL; Multi-Vitamins; Fish OIL



Possible Trilipix side effects in

Reported by a physician from United States on 2012-06-18

Patient:

Reactions: Headache

Drug(s) suspected as cause:
Effexor XR
    Dosage: 150 mg, am and pm
    Indication: Depression

Effexor XR
    Indication: Anxiety

Lovaza
    Dosage: 1 g, 2x/day
    Indication: Blood Cholesterol Abnormal

Omeprazole
    Dosage: 20 mg, 7 am
    Indication: Gastric PH Increased

Trilipix
    Dosage: 135 mg, am
    Indication: Blood Cholesterol Abnormal

Zetia
    Dosage: 10 mg, 5pm
    Indication: Lipids Abnormal



Possible Trilipix side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 61 year old female

Reactions: Dyspnoea, Hypersensitivity

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

Metoprolol Tartrate

Trilipix

Other drugs received by patient: Isosorbide Dinitrate; Zetia; Famotidine; Aspirin; Metformin HCL; Fish OIL; Gabapentin



Possible Trilipix side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 50 year old male

Reactions: Benign Colonic Neoplasm, Dyspnoea, Paranoia, Wheezing, Haemorrhoids, Conductive Deafness, Anxiety, Haematochezia, Insomnia, Obesity, Chest Pain, Cough

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

Crestor
    Administration route: Oral

Lisinopril
    Administration route: Oral

Trilipix
    Administration route: Oral

Other drugs received by patient: Hydrochlorothiazide; Prednisone TAB; Prednisone TAB; Doxycycline Hyclate; Prednisone TAB; Dexilant



Possible Trilipix side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: female, weighing 95.2 kg (209.5 pounds)

Reactions: Myalgia, Blood Cholesterol Increased, Headache, Poor Quality Drug Administered

Drug(s) suspected as cause:
Ibuprofen (Advil)
    Dosage: unk, 4 capsules as needed either daily or two times a day
    Administration route: Oral
    Indication: Arthritis

Trilipix
    Dosage: unk
    Administration route: Oral
    Indication: Blood Cholesterol Abnormal

Other drugs received by patient: Metformin; Accupril



Possible Trilipix side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: female, weighing 102.5 kg (225.5 pounds)

Reactions: Alopecia

Drug(s) suspected as cause:
Trilipix



Possible Trilipix side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: female, weighing 88.5 kg (194.8 pounds)

Reactions: Hypoaesthesia, Prothrombin Time Prolonged, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix
    Indication: Blood Cholesterol Increased
    Start date: 2007-01-01

Trilipix
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Ramipril; Warfarin Sodium; Nifedipine; Warfarin Sodium; Niaspan; Metformin HCL; Crestor; Niaspan



Possible Trilipix side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: male

Reactions: Abdominal Pain, Bile Duct Obstruction, Vomiting, Diabetes Mellitus, Pancreatic Pseudocyst, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix
    Indication: Blood Cholesterol Increased
    Start date: 2009-01-01

Zetia
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2009-01-01



Possible Trilipix side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: male, weighing 85.7 kg (188.6 pounds)

Reactions: Renal Failure, Blood Potassium Increased, Thyroid Disorder, Diabetic Blindness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Glucotrol
    Dosage: 10 mg, daily
    Indication: Diabetes Mellitus
    Start date: 1998-01-01

Lipitor
    Indication: Cardiovascular Event Prophylaxis

Lipitor
    Indication: Myocardial Infarction

Lipitor
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 1998-01-01

Tricor
    Dosage: 145 mg, 1x/day
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Trilipix
    Dosage: 45 mg, 1x/day
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Omega-3 Triglycerides; Vitamin D; Glucotrol XL; Januvia; Acetylsalicylic Acid; Coenzyme Q10; Calcium Carbonate / Famotidine / Magnesium Hydroxide



Possible Trilipix side effects in male

Reported by a lawyer from United States on 2012-05-03

Patient: male

Reactions: Abdominal Pain, Bile Duct Obstruction, Vomiting, Diabetes Mellitus, Pancreatic Pseudocyst, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix
    Indication: Blood Cholesterol Increased
    Start date: 2009-01-01

Zetia
    Dosage: 10 mg daily
    Indication: Blood Cholesterol Increased
    Start date: 2009-01-01



Possible Trilipix side effects in male

Reported by a physician from United States on 2012-05-03

Patient: male, weighing 144.4 kg (317.6 pounds)

Reactions: Pancreatitis Acute, Blood Triglycerides Increased, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix

Other drugs received by patient: M.v.i.; Metoprolol Tartrate; Hydrochlorothiazide



Possible Trilipix side effects in 36 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-26

Patient: 36 year old male, weighing 144.2 kg (317.3 pounds)

Reactions: Pancreatitis Acute, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix

Other drugs received by patient: Hydrochlorothiazide; Metoprolol Tartrate; Multi-Vitamin



Possible Trilipix side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: male

Reactions: Coronary Artery Occlusion

Drug(s) suspected as cause:
Trilipix



Possible Trilipix side effects in male

Reported by a pharmacist from United States on 2012-04-11

Patient: male, weighing 109.0 kg (239.8 pounds)

Reactions: Drug Hypersensitivity

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

Lipitor
    Dosage: unk

Trilipix
    Dosage: unk



Possible Trilipix side effects in male

Reported by a lawyer from United States on 2012-04-09

Patient: male

Reactions: Pancreatitis Acute, Emotional Distress, Bile Duct Obstruction, Diabetes Mellitus, Pseudocyst

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trilipix
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2009-01-01

Zetia
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2009-01-01

Other drugs received by patient: Lipitor

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