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Fenofibrate Side Effects

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Common Fenofibrate Side Effects


The most commonly reported Fenofibrate side effects (click to view or check a box to report):

Rhabdomyolysis (94)
Hepatic Function Abnormal (55)
High Density Lipoprotein Decreased (49)
Renal Failure Acute (48)
Liver Disorder (47)
Alanine Aminotransferase Increased (47)
Myalgia (45)
Aspartate Aminotransferase Increased (45)
Gamma-glutamyltransferase Increased (42)
Blood Creatine Phosphokinase Increased (35)
Renal Impairment (32)
Nausea (32)
Fatigue (31)
Liver Function Test Abnormal (30)
Arthralgia (29)
Malaise (29)
Asthenia (29)
Jaundice (26)
Renal Failure (25)
Dyspnoea (20)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Fenofibrate Side Effects Reported to FDA



Fenofibrate Side Effect Report#9981256
Nausea, Constipation, Abdominal Distension, Fatigue, Agitation, Urine Output Decreased, Flank Pain, Nasal Congestion, Abdominal Pain
This is a report of a 48-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypercholesterolaemia, who was treated with Fenofibrate (dosage: 1 Tablet Once Daily Taken By Mouth, start time:
Dec 05, 2013), combined with: NA. and developed a serious reaction and side effect(s): Nausea, Constipation, Abdominal Distension, Fatigue, Agitation, Urine Output Decreased, Flank Pain, Nasal Congestion, Abdominal Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in male patients, resulting in Nausea side effect.
Fenofibrate Side Effect Report#9948547
Vomiting, Abdominal Pain Upper
This report suggests a potential Fenofibrate Hexal Vomiting side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: hyperlipidaemia and used Fenofibrate Hexal (dosage: NA) starting
Jan 10, 2014. After starting Fenofibrate Hexal the patient began experiencing various side effects, including: Vomiting, Abdominal Pain UpperAdditional drugs used concurrently: NA. Although Fenofibrate Hexal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vomiting, may still occur.
Fenofibrate Side Effect Report#9927381
Autoimmune Hepatitis
This Autoimmune Hepatitis problem was reported by a physician from IT. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertriglyceridaemia,hepatitis c,essential hypertension. On
Nov 04, 2013 this consumer started treatment with Fenofibrate (dosage: NA). The following drugs were being taken at the same time:
  • Pegasys
  • Rasilez
  • Seloken
  • Zestoretic
  • Norvasc
When using Fenofibrate, the patient experienced the following unwanted symptoms/side effects: Autoimmune HepatitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Autoimmune Hepatitis, may become evident only after a product is in use by the general population.
Fenofibrate Side Effect Report#9891822
Dizziness
This Dizziness side effect was reported by a consumer or non-health professional from SG. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fenofibrate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fenofibrate the consumer reported adverse symptoms, such as: DizzinessThese side effects may potentially be related to Fenofibrate.
Fenofibrate Side Effect Report#9891679
Eye Swelling
This is a report of a 58-year-old female patient (weight: NA) from SG, suffering from the following health symptoms/conditions: NA, who was treated with Fenofibrate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Eye Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in female patients, resulting in Eye Swelling side effect.
Fenofibrate Side Effect Report#9870695
Poisoning, Exposure Via Ingestion, Completed Suicide
This report suggests a potential Fenofibrate Poisoning side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fenofibrate (dosage: NA) starting NS. After starting Fenofibrate the patient began experiencing various side effects, including: Poisoning, Exposure Via Ingestion, Completed SuicideAdditional drugs used concurrently:
  • Amlodipine (Df Oral)
  • Metoprolol (Df Oral)
  • Clonazepam (Df Oral)
  • Vitamin B3 (Df Oral)
Although Fenofibrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Fenofibrate Side Effect Report#9867198
Fatigue, Asthenia, Blood Creatinine Increased, Tubulointerstitial Nephritis
This Fatigue problem was reported by a health professional from GB. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperlipidaemia. On
Oct 04, 2012 this consumer started treatment with Fenofibrate (dosage: Unk). The following drugs were being taken at the same time:
  • Candesartan (16 Mg, Qd)
  • Paracetamol (Take 1-2 When Required Four Times Daily)
  • Atorvastatin (10 Mg, Qd)
  • Co-codamol (Unk, Prn)
When using Fenofibrate, the patient experienced the following unwanted symptoms/side effects: Fatigue, Asthenia, Blood Creatinine Increased, Tubulointerstitial NephritisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fatigue, may become evident only after a product is in use by the general population.
Fenofibrate Side Effect Report#9866894
Hepatitis
This Hepatitis side effect was reported by a consumer or non-health professional from US. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood triglycerides increased.The patient was prescribed Fenofibrate (drug dosage: NA), which was initiated on
Jan 09, 2014. Concurrently used drugs: NA..After starting to take Fenofibrate the consumer reported adverse symptoms, such as: HepatitisThese side effects may potentially be related to Fenofibrate. The patient was hospitalized.
Fenofibrate Side Effect Report#9859988
Tubulointerstitial Nephritis, Fatigue, Asthenia
This is a report of a 61-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: hyperlipidaemia, who was treated with Fenofibrate (dosage: NA, start time:
Oct 04, 2012), combined with:
  • Candesartan (16 Milligram Once Daily, Repeat.)
  • Paracetamol (500 Mg (as Required), Take 1-2 When Required Four Times Daily)
  • Atorvastatin
  • Co-codamol (8mg/500mg. 1-2 When Required Four Times Daily)
and developed a serious reaction and side effect(s): Tubulointerstitial Nephritis, Fatigue, Asthenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in female patients, resulting in Tubulointerstitial Nephritis side effect.
Fenofibrate Side Effect Report#9847349
Abdominal Pain, Diarrhoea
This report suggests a potential Fenofibrate Tablets Abdominal Pain side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol increased and used Fenofibrate Tablets (dosage: NA) starting 201306. After starting Fenofibrate Tablets the patient began experiencing various side effects, including: Abdominal Pain, DiarrhoeaAdditional drugs used concurrently: NA. Although Fenofibrate Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Fenofibrate Side Effect Report#9845245
Anger
This Anger problem was reported by a consumer or non-health professional from US. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On NS this consumer started treatment with Fenofibrate (dosage: NA). The following drugs were being taken at the same time: NA. When using Fenofibrate, the patient experienced the following unwanted symptoms/side effects: AngerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anger, may become evident only after a product is in use by the general population.
Fenofibrate Side Effect Report#9838659
Fatigue, Asthenia, Blood Creatinine Increased, Tubulointerstitial Nephritis
This Fatigue side effect was reported by a physician from GB. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: hyperlipidaemia.The patient was prescribed Fenofibrate (drug dosage: NA), which was initiated on
Oct 04, 2012. Concurrently used drugs:
  • Candesartan (Repeat)
  • Paracetamol (Take 1-2 When Required Four Times Daily)
  • Atorvastatin
  • Co-codamol (8mg/500mg. 1-2 When Required Four Times Daily.)
.After starting to take Fenofibrate the consumer reported adverse symptoms, such as: Fatigue, Asthenia, Blood Creatinine Increased, Tubulointerstitial NephritisThese side effects may potentially be related to Fenofibrate.
Fenofibrate Side Effect Report#9820157
Rhabdomyolysis, Renal Failure Acute
This is a report of a 50-year-old female patient (weight: NA) from TR, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Fenofibrate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Rhabdomyolysis, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in female patients, resulting in Rhabdomyolysis side effect. The patient was hospitalized.
Fenofibrate Side Effect Report#9796014
International Normalised Ratio Increased
This report suggests a potential Fenofibrate Ratiopharm 200mg International Normalised Ratio Increased side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Fenofibrate Ratiopharm 200mg (dosage: 200 Milligram Daily;) starting 201308. After starting Fenofibrate Ratiopharm 200mg the patient began experiencing various side effects, including: International Normalised Ratio IncreasedAdditional drugs used concurrently:
  • Previscan (20 Milligram Daily; For 15 Years)
Although Fenofibrate Ratiopharm 200mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as International Normalised Ratio Increased, may still occur.
Fenofibrate Side Effect Report#9790011
Dyspnoea, Myalgia, Tenderness, Abdominal Pain Upper
This Dyspnoea problem was reported by a consumer or non-health professional from US. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood disorder. On
Mar 01, 2013 this consumer started treatment with Fenofibrate (dosage: 1 Pill). The following drugs were being taken at the same time: NA. When using Fenofibrate, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Myalgia, Tenderness, Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Fenofibrate Side Effect Report#9789388
International Normalised Ratio Increased
This International Normalised Ratio Increased side effect was reported by a health professional from FR. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: dyslipidaemia,cerebrovascular accident prophylaxis.The patient was prescribed Fenofibrate (drug dosage: NA), which was initiated on 1998. Concurrently used drugs:
  • Previscan
.After starting to take Fenofibrate the consumer reported adverse symptoms, such as: International Normalised Ratio IncreasedThese side effects may potentially be related to Fenofibrate.
Fenofibrate Side Effect Report#9780675
Renal Failure
This is a report of a 76-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Fenofibrate (dosage: 200 Mg/day, start time: NS), combined with:
  • Dronedarone (800 Mg/day)
  • Atenolol (Unk)
  • Digoxin (Unk)
  • Aliskiren (Unk)
  • Glibenclamide/metformin (Unk)
  • Enoxaparin (Unk)
  • Furosemide (Unk)
  • Furosemide/spironolactone (Unk)
and developed a serious reaction and side effect(s): Renal Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in female patients, resulting in Renal Failure side effect. The patient was hospitalized.
Fenofibrate Side Effect Report#9776108
Dyspnoea
This report suggests a potential Fenofibrate Tablets Dyspnoea side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood triglycerides increased and used Fenofibrate Tablets (dosage: NA) starting
Sep 07, 2013. After starting Fenofibrate Tablets the patient began experiencing various side effects, including: DyspnoeaAdditional drugs used concurrently: NA. Although Fenofibrate Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Fenofibrate Side Effect Report#9721149
Muscle Fatigue, Muscle Atrophy, Fatigue, Sleep Disorder, Constipation, Oedema Mouth, Pain, Myalgia
This Muscle Fatigue problem was reported by a consumer or non-health professional from GB. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On 2005 this consumer started treatment with Fenofibrate (dosage: NA). The following drugs were being taken at the same time:
  • Simvastatin
  • Rosuvastatin
  • Atorvastatin
  • Pravastatin
  • Lipitor
  • Ezetimibe
When using Fenofibrate, the patient experienced the following unwanted symptoms/side effects: Muscle Fatigue, Muscle Atrophy, Fatigue, Sleep Disorder, Constipation, Oedema Mouth, Pain, MyalgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Fatigue, may become evident only after a product is in use by the general population.
Fenofibrate Side Effect Report#9711461
High Density Lipoprotein Decreased
This High Density Lipoprotein Decreased side effect was reported by a health professional from US. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fenofibrate (drug dosage: 160 Mg; Daily), which was initiated on
Sep 24, 2004. Concurrently used drugs: NA..After starting to take Fenofibrate the consumer reported adverse symptoms, such as: High Density Lipoprotein DecreasedThese side effects may potentially be related to Fenofibrate.
Fenofibrate Side Effect Report#9691385
Acute Hepatic Failure
This is a report of a 61-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Fenofibrate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Acute Hepatic Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in male patients, resulting in Acute Hepatic Failure side effect.
Fenofibrate Side Effect Report#9671385
Rash, Erythema Nodosum, Barrett^s Oesophagus
This report suggests a potential Fenofibrate Rash side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood triglycerides increased,gastrooesophageal reflux disease,blood cholesterol increased and used Fenofibrate (dosage: NA) starting 2011. After starting Fenofibrate the patient began experiencing various side effects, including: Rash, Erythema Nodosum, Barrett^s OesophagusAdditional drugs used concurrently:
  • Omeprazole Zydus
  • Atorvastatin
  • Aspirin
  • Multivitamin
Although Fenofibrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Fenofibrate Side Effect Report#9671379
Application Site Pain, Tremor, Hypersensitivity, Pruritus Genital
This Application Site Pain problem was reported by a consumer or non-health professional from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 16, 2012 this consumer started treatment with Fenofibrate (dosage: NA). The following drugs were being taken at the same time:
  • Ibuprofen Tablets
  • Podofilox Topocal Solution 0.5% (2 Doses/applications)
  • Metformin
  • Fish Oil
  • Aspirin Bayer
  • Ranitidine
  • Cilostazol
  • Atorvastatin
When using Fenofibrate, the patient experienced the following unwanted symptoms/side effects: Application Site Pain, Tremor, Hypersensitivity, Pruritus GenitalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Application Site Pain, may become evident only after a product is in use by the general population.
Fenofibrate Side Effect Report#9671377
Blood Cholesterol Abnormal, Muscular Weakness, Bone Pain, Arthralgia, Musculoskeletal Pain, Neck Pain, Back Pain, Arthralgia, Pain In Extremity
This Blood Cholesterol Abnormal side effect was reported by a health professional from US. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood triglycerides increased,blood cholesterol increased.The patient was prescribed Fenofibrate (drug dosage: NA), which was initiated on 201301. Concurrently used drugs:
  • Atorvastatin
  • Atorvastatin
  • Clopidogrel
  • Nadolol
.After starting to take Fenofibrate the consumer reported adverse symptoms, such as: Blood Cholesterol Abnormal, Muscular Weakness, Bone Pain, Arthralgia, Musculoskeletal Pain, Neck Pain, Back Pain, Arthralgia, Pain In ExtremityThese side effects may potentially be related to Fenofibrate.
Fenofibrate Side Effect Report#9671355
Peripheral Coldness, Myalgia
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Fenofibrate (dosage: NA, start time: 201212), combined with:
  • Vytorin (10/40)
  • Diltiazem Cd
  • Doxazosin
  • Quinapril
  • Folic Acid
  • Coumadin (Varying Doses)
  • Metformin
  • Januvia
and developed a serious reaction and side effect(s): Peripheral Coldness, Myalgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenofibrate treatment in female patients, resulting in Peripheral Coldness side effect.


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The appearance of Fenofibrate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Fenofibrate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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