About this FactMed analysis covering adverse side effect reports of GEMFIBROZIL patients who developed myopathy.

FactMed provides MD-approved analysis to help both patients, researchers, and physicians accurately assess the risk profile for more than 20,000 different pharmaceutical products. The below report offers compiled information from Food & Drug Administration and FactMed user submissions. Between January 2004 and October 2012, 41 individuals taking GEMFIBROZIL reported myopathy to the FDA. A total of 5656 GEMFIBROZIL drug adverse event reaction reports were made with the FDA during this time period. Often the FDA only receives reports of the most critical and severe cases; these numbers may therefore underrepresent the complication rate of the medication.

FDA Research Report

Introduction This page is designed to help you determine the relationship, if any, between GEMFIBROZIL and myopathy. In doing so, we compare GEMFIBROZIL with other drugs that cause myopathy, to help you evaluate whether or not GEMFIBROZIL causes myopathy. Likewise, this page shows the most highly-reported side effects of GEMFIBROZIL, so you can see if myopathy ranks among GEMFIBROZIL's most well-known side effects.
Summary Statistics
Reports of GEMFIBROZIL causing myopathy: 41
Reports of any side effect of GEMFIBROZIL : 5656
Percentage of GEMFIBROZIL patients where myopathy is a reported side effect: 0.7249%

FDA reports of any drug causing myopathy : 3605
Average percentage for all medicated patients where myopathy is reported as a complication: 0.0226%

Physician opinion on GEMFIBROZIL as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing GEMFIBROZIL:
HYPERLIPIDAEMIA ( 269 patients )
BLOOD CHOLESTEROL INCREASED ( 230 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 228 patients )
DRUG USE FOR UNKNOWN INDICATION ( 200 patients )
BLOOD CHOLESTEROL ( 144 patients )
BLOOD TRIGLYCERIDES INCREASED ( 135 patients )
HYPERTRIGLYCERIDAEMIA ( 110 patients )
HYPERCHOLESTEROLAEMIA ( 88 patients )
BLOOD TRIGLYCERIDES ( 55 patients )
DYSLIPIDAEMIA ( 48 patients )
BLOOD CHOLESTEROL ABNORMAL ( 38 patients )
ILL-DEFINED DISORDER ( 26 patients )
LIPIDS INCREASED ( 24 patients )
DIABETES MELLITUS ( 23 patients )
BLOOD TRIGLYCERIDES DECREASED ( 17 patients )
HYPERTENSION ( 16 patients )
CARDIAC DISORDER ( 11 patients )
LIPIDS ( 9 patients )
BLOOD TRIGLYCERIDES ABNORMAL ( 8 patients )
COMPLETED SUICIDE ( 6 patients )
HIGH DENSITY LIPOPROTEIN DECREASED ( 6 patients )
SUICIDE ATTEMPT ( 4 patients )
MIXED HYPERLIPIDAEMIA ( 4 patients )
LOW DENSITY LIPOPROTEIN INCREASED ( 3 patients )
METABOLIC SYNDROME ( 3 patients )
MALIGNANT MELANOMA ( 3 patients )
BLOOD PRESSURE ( 3 patients )
CORONARY ARTERY DISEASE ( 2 patients )
ANTICOAGULANT THERAPY ( 2 patients )
LIPIDS ABNORMAL ( 2 patients )
TYPE 2 DIABETES MELLITUS ( 2 patients )
XANTHOMATOSIS ( 2 patients )
RHABDOMYOLYSIS ( 2 patients )
TRANSPLANT REJECTION ( 2 patients )
DYSPEPSIA ( 2 patients )
BLOOD CHOLESTEROL DECREASED ( 2 patients )
METABOLIC DISORDER ( 2 patients )
CEREBROVASCULAR ACCIDENT PROPHYLAXIS ( 1 patients )
RENAL CELL CARCINOMA STAGE UNSPECIFIED ( 1 patients )
DIABETES MELLITUS NON-INSULIN-DEPENDENT ( 1 patients )
BENIGN PROSTATIC HYPERPLASIA ( 1 patients )
MANIA ( 1 patients )
FATIGUE ( 1 patients )
GASTROINTESTINAL INFLAMMATION ( 1 patients )
MYOCARDIAL ISCHAEMIA ( 1 patients )
HIV INFECTION ( 1 patients )
POLYNEUROPATHY ( 1 patients )
PULMONARY HYPERTENSION ( 1 patients )
ACUTE LYMPHOCYTIC LEUKAEMIA ( 1 patients )
ATRIAL FIBRILLATION ( 1 patients )
TYPE V HYPERLIPIDAEMIA ( 1 patients )
GASTRIC DISORDER ( 1 patients )
OEDEMA ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with myopathy:

LIPITOR (517 patients)
ZOCOR (480 patients)
ASPIRIN (474 patients)
SIMVASTATIN (410 patients)
FOSAMAX (309 patients)
PREDNISONE (241 patients)
CRESTOR (239 patients)
ZOMETA (201 patients)
PREDNISOLONE (199 patients)
LASIX (177 patients)
FUROSEMIDE (162 patients)
ZETIA (153 patients)
HYDROCHLOROTHIAZIDE (144 patients)
PREDNISONE TAB (139 patients)
LEVOTHYROXINE SODIUM (138 patients)
VIOXX (130 patients)
ALLOPURINOL (125 patients)
DEXAMETHASONE (124 patients)
INSULIN (120 patients)
COUMADIN (118 patients)
CYCLOSPORINE (113 patients)
ATENOLOL (112 patients)
ATORVASTATIN CALCIUM (110 patients)
NORVASC (108 patients)
CLARITHROMYCIN (107 patients)
AMBIEN (104 patients)
MYCOPHENOLATE MOFETIL (103 patients)
LISINOPRIL (99 patients)
NOROXIN (98 patients)
DECADRON (97 patients)
OMEPRAZOLE (97 patients)
POTASSIUM CHLORIDE (96 patients)
SORAFENIB (RAF KINASE INHIBITOR) (95 patients)
GABAPENTIN (94 patients)
SYNTHROID (94 patients)
LAMIVUDINE (90 patients)
AMLODIPINE (90 patients)
RAMIPRIL (89 patients)
NEXIUM (88 patients)
PRILOSEC (87 patients)
METHYLPREDNISOLONE (85 patients)
WARFARIN SODIUM (83 patients)
ZIDOVUDINE (82 patients)
ALBUTEROL (82 patients)
LANSOPRAZOLE (80 patients)
MEK INHIBITOR (DIHYDROXYPROP-DIFLU-METHOXYPHEN-CYCLOPROPA-SULFAMI) (80 patients)
PROTONIX (79 patients)
ACETAMINOPHEN (77 patients)
FOLIC ACID (77 patients)
MULTI-VITAMINS (75 patients)
XANAX (75 patients)
COZAAR (73 patients)
NEURONTIN (73 patients)
REMICADE (71 patients)
REVLIMID (69 patients)
HUMIRA (68 patients)
AMIODARONE HCL (67 patients)
FLONASE (65 patients)
CELEXA (64 patients)
FERROUS SULFATE TAB (64 patients)
ATORVASTATIN (64 patients)
AMLODIPINE BESYLATE (64 patients)
SPIRONOLACTONE (63 patients)
MAGNEVIST (62 patients)
VYTORIN (62 patients)
ZOLOFT (61 patients)
PEPCID (60 patients)
PROGRAF (60 patients)
CITALOPRAM HYDROBROMIDE (59 patients)
VICODIN (59 patients)
ADVAIR DISKUS 100/50 (59 patients)
ULTRAVIST 150 (59 patients)
PLAVIX (59 patients)
METHOTREXATE (58 patients)
COLCHICINE (58 patients)
AREDIA (57 patients)
OXYCONTIN (57 patients)
LYRICA (57 patients)
DIDANOSINE (56 patients)
ENALAPRIL MALEATE (55 patients)
HEPARIN SODIUM INJECTION (55 patients)
TAMOXIFEN CITRATE (55 patients)
ACYCLOVIR (52 patients)
FENOFIBRATE (52 patients)
PRAVASTATIN (52 patients)
CLONAZEPAM (51 patients)
ITRACONAZOLE (51 patients)
CYCLOPHOSPHAMIDE (51 patients)
DIGOXIN (49 patients)
SEBIVO (49 patients)
TOPROL-XL (49 patients)
LORAZEPAM (48 patients)
DILTIAZEM (48 patients)
LORTAB (48 patients)
ELAVIL (47 patients)
DIFLUCAN (47 patients)
METOPROLOL TARTRATE (46 patients)
ATIVAN (46 patients)
VELCADE (45 patients)
ALENDRONATE SODIUM (45 patients)
VITAMIN D (45 patients)
KLOR-CON (45 patients)
PRAVACHOL (45 patients)
WELLBUTRIN (44 patients)
TRICOR (44 patients)
DARVOCET-N 100 (44 patients)
PERCOCET (44 patients)
RAPAMUNE (43 patients)
ASCORBIC ACID (43 patients)
LEVAQUIN (43 patients)
AROMASIN (43 patients)
DIAZEPAM (43 patients)
ZANTAC (43 patients)
GEMFIBROZIL (41 patients)
CELEBREX (41 patients)
OXYCODONE HCL (41 patients)
ABACAVIR (40 patients)
LEXAPRO (40 patients)
NIFEDIPINE (40 patients)
RADIATION THERAPY (39 patients)
ACETYLSALICYLIC ACID SRT (39 patients)
ACIPHEX (39 patients)
METFORMIN HCL (39 patients)
IRON (39 patients)
ALTACE (39 patients)
TACROLIMUS (38 patients)
EFAVIRENZ (38 patients)
ZYPREXA (38 patients)
ZYRTEC (38 patients)
LESCOL (37 patients)
[THERAPY UNSPECIFIED] (37 patients)
METOPROLOL (37 patients)
GLEEVEC (37 patients)
PANTOPRAZOLE SODIUM (36 patients)
FOSAMAX PLUS D (36 patients)
PROPRANOLOL HYDROCHLORIDE (36 patients)
EFFEXOR (36 patients)
AMIODARONE (36 patients)
CEFTRIAXONE (36 patients)
HERCEPTIN (35 patients)
THALIDOMIDE (35 patients)
FUSIDIC ACID (35 patients)
SINGULAIR (35 patients)
IBUPROFEN (35 patients)
SPIRIVA (35 patients)
LOSARTAN POTASSIUM (35 patients)
VANCOMYCIN (35 patients)
WARFARIN (34 patients)
PERIDEX (34 patients)
BISOPROLOL (34 patients)
HYZAAR (34 patients)
SIROLIMUS (34 patients)
SOLU-MEDROL (34 patients)
ALPRAZOLAM (34 patients)
CO-TRIMOXAZOLE (34 patients)
AMITRIPTYLINE HCL (34 patients)
COREG (34 patients)
VITAMINS (UNSPECIFIED) (33 patients)
ACETYLSALICYLIC ACID (33 patients)
AZATHIOPRINE (33 patients)
ZOFRAN (33 patients)
CALTRATE +D (33 patients)
PROTEINASE INHIBITORS (33 patients)
CARTIA /USA/ (33 patients)
NIASPAN (33 patients)
PANTOPRAZOLE (33 patients)
MEGESTROL ACETATE (32 patients)
COMPAZINE (32 patients)
ADENOSINE (32 patients)
ALDACTONE (32 patients)
LANTUS (32 patients)
GASMOTIN (32 patients)
PROZAC (32 patients)
ARIMIDEX (31 patients)
AVELOX (31 patients)
FENTANYL (31 patients)
CALCIUM (UNSPECIFIED) (31 patients)
PAXIL (31 patients)
GLIPIZIDE (31 patients)
FLUCONAZOLE (31 patients)
ARANESP (31 patients)
CLARITIN (31 patients)
DILAUDID (31 patients)
NEUPOGEN (31 patients)
AVANDIA (31 patients)
B12 ^RECIP^ (30 patients)
K-DUR (30 patients)
CALCIUM CARBONATE (30 patients)
CELLCEPT (30 patients)
METFORMIN (30 patients)
CLOPIDOGREL (30 patients)
TRAMADOL HCL (30 patients)
REQUIP (29 patients)
CARVEDILOL (29 patients)
GLUCOPHAGE (29 patients)
FLOMAX (29 patients)
ZESTRIL (29 patients)
MIRTAZAPINE (29 patients)
TIAZAC (29 patients)
CAPECITABINE (29 patients)
KETEK (29 patients)
NICORANDIL (29 patients)
VERAPAMIL (29 patients)
CYMBALTA (28 patients)
RALTEGRAVIR (28 patients)
LOVASTATIN (28 patients)
CALCIUM (28 patients)
ACTOS (28 patients)
MICARDIS (28 patients)
DILTIAZEM HYDROCHLORIDE (28 patients)
Most common side effects for patients taking GEMFIBROZIL:
NAUSEA (427 patients)
RHABDOMYOLYSIS (392 patients)
DYSPNOEA (381 patients)
RENAL FAILURE ACUTE (370 patients)
DIZZINESS (367 patients)
PAIN (355 patients)
ASTHENIA (347 patients)
DIARRHOEA (319 patients)
FATIGUE (311 patients)
ANXIETY (301 patients)
CHEST PAIN (282 patients)
DEPRESSION (270 patients)
VOMITING (261 patients)
MYOCARDIAL INFARCTION (260 patients)
MYALGIA (255 patients)
ANAEMIA (247 patients)
DIABETES MELLITUS (243 patients)
DRUG INTERACTION (236 patients)
PAIN IN EXTREMITY (233 patients)
CARDIAC FAILURE CONGESTIVE (230 patients)
HEADACHE (228 patients)
DRUG INEFFECTIVE (225 patients)
WEIGHT DECREASED (224 patients)
OEDEMA PERIPHERAL (223 patients)
FALL (220 patients)
BACK PAIN (217 patients)
ARTHRALGIA (216 patients)
BLOOD GLUCOSE INCREASED (213 patients)
PNEUMONIA (197 patients)
ABDOMINAL PAIN (190 patients)
RENAL FAILURE (181 patients)
HYPOTENSION (179 patients)
WEIGHT INCREASED (176 patients)
HYPERTENSION (170 patients)
DEHYDRATION (168 patients)
PANCREATITIS (164 patients)
MALAISE (161 patients)
PYREXIA (161 patients)
INSOMNIA (157 patients)
CONSTIPATION (156 patients)
RASH (156 patients)
MUSCLE SPASMS (154 patients)
HYPOAESTHESIA (151 patients)
INJURY (148 patients)
COUGH (148 patients)
PARAESTHESIA (148 patients)
DEATH (145 patients)
CEREBROVASCULAR ACCIDENT (145 patients)
BLOOD CREATINE PHOSPHOKINASE INCREASED (144 patients)
CONFUSIONAL STATE (139 patients)
BLOOD TRIGLYCERIDES INCREASED (138 patients)
FLUSHING (137 patients)
CORONARY ARTERY DISEASE (137 patients)
ATRIAL FIBRILLATION (131 patients)
GASTROOESOPHAGEAL REFLUX DISEASE (129 patients)
SYNCOPE (125 patients)
TYPE 2 DIABETES MELLITUS (122 patients)
FEELING ABNORMAL (120 patients)
GAIT DISTURBANCE (118 patients)
BLOOD CHOLESTEROL INCREASED (117 patients)
URINARY TRACT INFECTION (117 patients)
ABDOMINAL PAIN UPPER (115 patients)
PRURITUS (114 patients)
LOSS OF CONSCIOUSNESS (111 patients)
THROMBOCYTOPENIA (107 patients)
HYPOGLYCAEMIA (106 patients)
BLOOD CREATININE INCREASED (102 patients)
HAEMOGLOBIN DECREASED (102 patients)
VISION BLURRED (101 patients)
HYPERLIPIDAEMIA (100 patients)
PALPITATIONS (100 patients)
HYPERKALAEMIA (98 patients)
DECREASED APPETITE (95 patients)
MENTAL STATUS CHANGES (95 patients)
MUSCULAR WEAKNESS (94 patients)
TREMOR (94 patients)
HYPERHIDROSIS (93 patients)
OSTEOARTHRITIS (92 patients)
NEUROPATHY PERIPHERAL (92 patients)
CONDITION AGGRAVATED (90 patients)
HYPERCHOLESTEROLAEMIA (90 patients)
RENAL IMPAIRMENT (89 patients)
RENAL FAILURE CHRONIC (88 patients)
INTERNATIONAL NORMALISED RATIO INCREASED (88 patients)
CONVULSION (87 patients)
OSTEONECROSIS OF JAW (84 patients)
HYPERGLYCAEMIA (83 patients)
CARDIAC ARREST (83 patients)
ECONOMIC PROBLEM (82 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (82 patients)
BRADYCARDIA (82 patients)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (80 patients)
SOMNOLENCE (79 patients)
COMPLETED SUICIDE (79 patients)
ALANINE AMINOTRANSFERASE INCREASED (79 patients)
PLEURAL EFFUSION (79 patients)
CELLULITIS (78 patients)
CARDIAC DISORDER (77 patients)
BLOOD PRESSURE INCREASED (77 patients)
SEPSIS (77 patients)
CONTUSION (75 patients)
RESPIRATORY FAILURE (74 patients)
MUSCULOSKELETAL PAIN (73 patients)
DYSURIA (72 patients)
HYPERSENSITIVITY (71 patients)
MEMORY IMPAIRMENT (70 patients)
ERYTHEMA (70 patients)
UPPER RESPIRATORY TRACT INFECTION (70 patients)
DIABETES MELLITUS INADEQUATE CONTROL (68 patients)
ANHEDONIA (68 patients)
CHILLS (68 patients)
ABDOMINAL DISTENSION (66 patients)
AGITATION (66 patients)
GASTROINTESTINAL HAEMORRHAGE (66 patients)
STRESS (65 patients)
BRONCHITIS (65 patients)
SINUSITIS (64 patients)
DYSPHAGIA (64 patients)
ANGINA PECTORIS (64 patients)
DYSPEPSIA (64 patients)
PLATELET COUNT DECREASED (63 patients)
BLOOD GLUCOSE DECREASED (63 patients)
MIGRAINE (62 patients)
TOOTHACHE (62 patients)
TACHYCARDIA (62 patients)
UNEVALUABLE EVENT (61 patients)
TINNITUS (61 patients)
BALANCE DISORDER (61 patients)
BONE DISORDER (61 patients)
HYPOTHYROIDISM (60 patients)
SLEEP DISORDER (60 patients)
HAEMORRHOIDS (60 patients)
FLATULENCE (60 patients)
EMOTIONAL DISTRESS (60 patients)
CHEST DISCOMFORT (60 patients)
DYSGEUSIA (59 patients)
OVERDOSE (59 patients)
DRY MOUTH (58 patients)
CARDIOMEGALY (58 patients)
OBESITY (58 patients)
TRANSIENT ISCHAEMIC ATTACK (57 patients)
ATELECTASIS (57 patients)
INTERVERTEBRAL DISC PROTRUSION (57 patients)
OSTEONECROSIS (57 patients)
IRRITABILITY (56 patients)
EXOSTOSIS (56 patients)
HAEMATURIA (56 patients)
CHOLELITHIASIS (56 patients)
DRUG DOSE OMISSION (55 patients)
GASTRITIS (54 patients)
EPISTAXIS (54 patients)
AMNESIA (54 patients)
SLEEP APNOEA SYNDROME (54 patients)
HEPATIC ENZYME INCREASED (54 patients)
ABNORMAL DREAMS (53 patients)
HEPATIC STEATOSIS (53 patients)
HEART RATE IRREGULAR (53 patients)
ARRHYTHMIA (53 patients)
OSTEOPOROSIS (52 patients)
RECTAL HAEMORRHAGE (52 patients)
UNRESPONSIVE TO STIMULI (52 patients)
SWELLING (52 patients)
ABASIA (51 patients)
VISUAL ACUITY REDUCED (51 patients)
DIVERTICULITIS (49 patients)
DEEP VEIN THROMBOSIS (49 patients)
DIABETIC NEUROPATHY (49 patients)
INFECTION (49 patients)
ABDOMINAL DISCOMFORT (48 patients)
HALLUCINATION (48 patients)
DRY SKIN (48 patients)
OSTEOMYELITIS (48 patients)
TRICUSPID VALVE INCOMPETENCE (47 patients)
LIVER FUNCTION TEST ABNORMAL (47 patients)
DRUG EFFECT DECREASED (47 patients)
HYPONATRAEMIA (47 patients)
ARTHRITIS (47 patients)
HEART RATE INCREASED (46 patients)
LETHARGY (46 patients)
CARDIAC MURMUR (46 patients)
MITRAL VALVE INCOMPETENCE (46 patients)
DYSPNOEA EXERTIONAL (46 patients)
RASH PRURITIC (46 patients)
HYPOACUSIS (46 patients)
PHARMACEUTICAL PRODUCT COMPLAINT (45 patients)
DISABILITY (45 patients)
TREATMENT NONCOMPLIANCE (45 patients)
MULTI-ORGAN FAILURE (45 patients)
DISTURBANCE IN ATTENTION (44 patients)
HIATUS HERNIA (44 patients)
PULMONARY EMBOLISM (44 patients)
NECK PAIN (44 patients)
INTERVERTEBRAL DISC DEGENERATION (44 patients)
HAEMORRHAGE (44 patients)
OEDEMA (43 patients)
SURGERY (43 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (42 patients)
CORONARY ARTERY OCCLUSION (42 patients)
MULTIPLE INJURIES (42 patients)
WHITE BLOOD CELL COUNT INCREASED (42 patients)
TOOTH EXTRACTION (42 patients)
WHITE BLOOD CELL COUNT DECREASED (42 patients)
SPINAL OSTEOARTHRITIS (41 patients)
BLOOD PRESSURE DECREASED (41 patients)
VENTRICULAR HYPERTROPHY (41 patients)
DRUG HYPERSENSITIVITY (41 patients)
EMOTIONAL DISORDER (41 patients)
MYOSITIS (41 patients)
MYOPATHY (41 patients)
ORAL PAIN (41 patients)

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Recent FactMed Activity for GEMFIBROZIL


Issue Description / Topic Timestamp
QUESTION
DRY MOUTH
How can I get rid of the servers dry mouth that has developed since I started taking GEMFRIBROZIL? 2017-01-28 11:01:32
QUESTION
DRY MOUTH
What can I do to get rid of my dry mouth that has developed since I started taking GEMFIBROZIL? 2017-01-31 15:02:30
QUESTION
DRY MOUTH
What can I do to get rid of my dry mouth that has developed since I started taking GEMFIBROZIL? 2017-01-31 20:00:44
QUESTION
PRODUCTIVE COUGH
Has anyone had a productive cough while taking gemfribizol 2017-02-18 10:25:19

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