Is myopathy a side effect of NOROXIN ? ( FactMed.com )

About this FactMed analysis covering adverse side effect reports of NOROXIN 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, 98 individuals taking NOROXIN reported myopathy to the FDA. A total of 954 NOROXIN 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 NOROXIN and myopathy. In doing so, we compare NOROXIN with other drugs that cause myopathy, to help you evaluate whether or not NOROXIN causes myopathy. Likewise, this page shows the most highly-reported side effects of NOROXIN, so you can see if myopathy ranks among NOROXIN's most well-known side effects.

Summary Statistics
Reports of NOROXIN causing myopathy: 98
Reports of any side effect of NOROXIN : 954
Percentage of NOROXIN patients where myopathy is a reported side effect: 10.2725%

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 NOROXIN as adverse event culprit:

Overall opinion for all reports of this drug:

Most frequent diagnoses/indications for prescribing NOROXIN:

URINARY TRACT INFECTION ( 257 patients )
CYSTITIS ( 54 patients )
DRUG USE FOR UNKNOWN INDICATION ( 32 patients )
PROPHYLAXIS ( 21 patients )
PROSTATITIS ( 18 patients )
PYREXIA ( 11 patients )
ESCHERICHIA URINARY TRACT INFECTION ( 9 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 8 patients )
INFECTION PROPHYLAXIS ( 7 patients )
DYSURIA ( 7 patients )
DIARRHOEA ( 6 patients )
ENTERITIS INFECTIOUS ( 6 patients )
PYELONEPHRITIS ( 6 patients )
FOOD POISONING ( 5 patients )
INFECTION ( 4 patients )
ESCHERICHIA INFECTION ( 4 patients )
GASTROENTERITIS ( 3 patients )
PROPHYLAXIS URINARY TRACT INFECTION ( 3 patients )
PROSTATECTOMY ( 3 patients )
BRONCHITIS ( 3 patients )
URINARY TRACT DISORDER ( 3 patients )
ABDOMINAL PAIN ( 3 patients )
ANTIBIOTIC PROPHYLAXIS ( 3 patients )
BRONCHOPNEUMOPATHY ( 3 patients )
URINARY INCONTINENCE ( 2 patients )
HAEMOLYTIC URAEMIC SYNDROME ( 2 patients )
ACUTE SINUSITIS ( 2 patients )
ILL-DEFINED DISORDER ( 2 patients )
ASCITES ( 2 patients )
MORGANELLA INFECTION ( 2 patients )
CAMPYLOBACTER INTESTINAL INFECTION ( 2 patients )
GASTRIC INFECTION ( 2 patients )
UPPER RESPIRATORY TRACT INFLAMMATION ( 2 patients )
PERITONEAL INFECTION ( 2 patients )
GENITOURINARY TRACT INFECTION ( 2 patients )
YERSINIA INFECTION ( 2 patients )
CYSTITIS BACTERIAL ( 2 patients )
RENAL COLIC ( 2 patients )
CANDIDIASIS ( 2 patients )
ORCHITIS ( 2 patients )
CHROMATURIA ( 1 patients )
PERITONITIS BACTERIAL ( 1 patients )
GASTROINTESTINAL DISORDER ( 1 patients )
BLADDER PAIN ( 1 patients )
ESCHAR ( 1 patients )
NASOPHARYNGITIS ( 1 patients )
SELF-MEDICATION ( 1 patients )
NOSOCOMIAL INFECTION ( 1 patients )
CHOLELITHIASIS ( 1 patients )
GASTROINTESTINAL CANDIDIASIS ( 1 patients )
CHRONIC SINUSITIS ( 1 patients )
PHARYNGITIS ( 1 patients )
HYPERTENSION ( 1 patients )
DRUG EXPOSURE DURING PREGNANCY ( 1 patients )
PROSTATE INFECTION ( 1 patients )
PROSTATIC DISORDER ( 1 patients )
BACTERIAL SEPSIS ( 1 patients )
LITHOTRIPSY ( 1 patients )
EPIDIDYMITIS ( 1 patients )
BLADDER SPASM ( 1 patients )
MULTIPLE SCLEROSIS ( 1 patients )
NEONATAL INFECTIVE MASTITIS ( 1 patients )
SEPSIS ( 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 NOROXIN:

HEPATITIS (113 patients)
TENDON DISORDER (101 patients)
BLOOD CREATINE PHOSPHOKINASE INCREASED (99 patients)
MYOPATHY (98 patients)
INJECTION SITE RASH (90 patients)
DRUG INTERACTION (56 patients)
PYREXIA (45 patients)
CONFUSIONAL STATE (40 patients)
DIARRHOEA (33 patients)
RENAL FAILURE ACUTE (33 patients)
BURSITIS (33 patients)
VOMITING (32 patients)
INTERNATIONAL NORMALISED RATIO INCREASED (31 patients)
ARTHRITIS (31 patients)
ASTHENIA (31 patients)
URINARY TRACT INFECTION (30 patients)
DYSPNOEA (30 patients)
CYTOLYTIC HEPATITIS (30 patients)
JAUNDICE (29 patients)
ANAEMIA (29 patients)
ARTHRALGIA (29 patients)
NAUSEA (29 patients)
DRUG EXPOSURE DURING PREGNANCY (28 patients)
CHOLESTASIS (28 patients)
ABDOMINAL PAIN (26 patients)
HYPONATRAEMIA (26 patients)
PRURITUS (25 patients)
MYALGIA (25 patients)
TENDONITIS (24 patients)
THROMBOCYTOPENIA (24 patients)
FALL (23 patients)
PYELONEPHRITIS (23 patients)
RENAL FAILURE (23 patients)
PANCREATITIS ACUTE (23 patients)
DRUG ERUPTION (23 patients)
NEUTROPENIA (21 patients)
OEDEMA PERIPHERAL (21 patients)
OVERDOSE (20 patients)
RASH MACULO-PAPULAR (20 patients)
MALAISE (20 patients)
AGRANULOCYTOSIS (19 patients)
TOXIC SKIN ERUPTION (19 patients)
ANOREXIA (18 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (18 patients)
RHABDOMYOLYSIS (18 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (17 patients)
RASH (17 patients)
SOMNOLENCE (17 patients)
DEHYDRATION (17 patients)
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (16 patients)
ESCHERICHIA INFECTION (16 patients)
DERMATITIS BULLOUS (16 patients)
BLOOD BILIRUBIN INCREASED (16 patients)
PANCYTOPENIA (16 patients)
PAIN (16 patients)
DEATH (16 patients)
ABNORMAL BEHAVIOUR (15 patients)
BACTERIAL PYELONEPHRITIS (15 patients)
HAEMATOMA (15 patients)
PURPURA (14 patients)
BLOOD CREATININE INCREASED (14 patients)
ERYTHEMA (14 patients)
ALANINE AMINOTRANSFERASE INCREASED (13 patients)
FATIGUE (13 patients)
HYPOKALAEMIA (13 patients)
CONDITION AGGRAVATED (13 patients)
CONSTIPATION (13 patients)
TACHYCARDIA (13 patients)
STEVENS-JOHNSON SYNDROME (12 patients)
TREMOR (12 patients)
EPISTAXIS (12 patients)
DEPRESSION (12 patients)
PLATELET COUNT DECREASED (12 patients)
CEREBROVASCULAR ACCIDENT (12 patients)
EPILEPSY (12 patients)
PAIN IN EXTREMITY (11 patients)
ANGIOEDEMA (11 patients)
ANXIETY (11 patients)
ODYNOPHAGIA (11 patients)
URTICARIA (11 patients)
VASCULAR PURPURA (11 patients)
HEADACHE (11 patients)
GINGIVAL BLEEDING (10 patients)
EOSINOPHILIA (10 patients)
DIZZINESS (10 patients)
VISUAL IMPAIRMENT (10 patients)
LEUKOPENIA (10 patients)
LEUKOCYTOCLASTIC VASCULITIS (10 patients)
ASCITES (10 patients)
PARAESTHESIA (10 patients)
HYPERKALAEMIA (10 patients)
MUSCULAR WEAKNESS (10 patients)
BLOOD PRESSURE DECREASED (10 patients)
SUBDURAL HAEMATOMA (10 patients)
C-REACTIVE PROTEIN INCREASED (10 patients)
HAEMATURIA (10 patients)
HYPERTONIA (10 patients)
ABORTION INDUCED (9 patients)
OFF LABEL USE (9 patients)
AGGRESSION (9 patients)
FACE OEDEMA (9 patients)
NECK PAIN (9 patients)
PEMPHIGOID (9 patients)
HAEMOLYTIC ANAEMIA (9 patients)
LACTIC ACIDOSIS (9 patients)
BRADYCARDIA (9 patients)
LOSS OF CONSCIOUSNESS (9 patients)
HAEMOGLOBIN DECREASED (9 patients)
PNEUMONIA (9 patients)
CHEST PAIN (9 patients)
HEPATIC FAILURE (9 patients)
HYPERSENSITIVITY (9 patients)
DECREASED APPETITE (9 patients)
ABDOMINAL PAIN UPPER (8 patients)
SKIN EXFOLIATION (8 patients)
PSEUDOMEMBRANOUS COLITIS (8 patients)
EYELID OEDEMA (8 patients)
GASTROINTESTINAL HAEMORRHAGE (8 patients)
MOTOR DYSFUNCTION (8 patients)
HEPATOCELLULAR INJURY (8 patients)
RESPIRATORY FAILURE (8 patients)
SKIN DISORDER (8 patients)
TOXIC EPIDERMAL NECROLYSIS (8 patients)
LIVER FUNCTION TEST ABNORMAL (8 patients)
WEIGHT DECREASED (8 patients)
GASTROENTERITIS (8 patients)
DRUG TOXICITY (8 patients)
PULMONARY EMBOLISM (8 patients)
HYPERTHERMIA (8 patients)
HEPATOCELLULAR DAMAGE (8 patients)
HEPATIC ENCEPHALOPATHY (7 patients)
RASH ERYTHEMATOUS (7 patients)
HYPERHIDROSIS (7 patients)
INTERSTITIAL LUNG DISEASE (7 patients)
DRUG INEFFECTIVE (7 patients)
ASTERIXIS (7 patients)
ATRIAL FIBRILLATION (7 patients)
MOUTH ULCERATION (7 patients)
MUSCULOSKELETAL STIFFNESS (7 patients)
MYOCARDIAL INFARCTION (7 patients)
NERVOUS SYSTEM DISORDER (7 patients)
TRANSAMINASES INCREASED (7 patients)
DEPRESSED LEVEL OF CONSCIOUSNESS (7 patients)
HALLUCINATION (7 patients)
RENAL IMPAIRMENT (7 patients)
PALLOR (7 patients)
HEPATIC NEOPLASM MALIGNANT (7 patients)
SYNCOPE (7 patients)
HYPOXIA (7 patients)
DEEP VEIN THROMBOSIS (7 patients)
ABDOMINAL DISTENSION (6 patients)
FOETOR HEPATICUS (6 patients)
DIABETES MELLITUS (6 patients)
PORTAL VEIN THROMBOSIS (6 patients)
ACUTE PULMONARY OEDEMA (6 patients)
AFFECTIVE DISORDER (6 patients)
AGITATION (6 patients)
WHITE BLOOD CELL COUNT DECREASED (6 patients)
DYSPHAGIA (6 patients)
LYMPHADENOPATHY (6 patients)
BACK PAIN (6 patients)
RED BLOOD CELL COUNT DECREASED (6 patients)
BLOOD AMYLASE INCREASED (6 patients)
MYOCLONUS (6 patients)
URINARY RETENTION (6 patients)
VIRAL LOAD INCREASED (6 patients)
MELAENA (6 patients)
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (6 patients)
HAEMORRHAGE (6 patients)
CEREBRAL ATROPHY (6 patients)
DISORIENTATION (6 patients)
RASH MORBILLIFORM (6 patients)
RECTAL HAEMORRHAGE (6 patients)
HEPATIC FUNCTION ABNORMAL (6 patients)
CHROMATURIA (6 patients)
HEPATITIS FULMINANT (6 patients)
SEPTIC SHOCK (6 patients)
HYPERAESTHESIA (6 patients)
COGWHEEL RIGIDITY (6 patients)
COMA (6 patients)
CONVULSION (6 patients)
ENCEPHALOPATHY (6 patients)
HYPOTENSION (6 patients)
ADVERSE EVENT (5 patients)
TENDON RUPTURE (5 patients)
LIVER DISORDER (5 patients)
RASH GENERALISED (5 patients)
HYPOAESTHESIA (5 patients)
OEDEMA (5 patients)
MOUTH HAEMORRHAGE (5 patients)
HEPATIC STEATOSIS (5 patients)
STREPTOCOCCAL SEPSIS (5 patients)
BLOOD ALKALINE PHOSPHATASE ABNORMAL (5 patients)
BLOOD ALKALINE PHOSPHATASE INCREASED (5 patients)
INSOMNIA (5 patients)
LIPASE INCREASED (5 patients)
THROMBOSIS (5 patients)
UPPER LIMB FRACTURE (5 patients)
BONE PAIN (5 patients)
HENOCH-SCHONLEIN PURPURA (5 patients)
HEPATITIS ACUTE (5 patients)
CLOSTRIDIUM DIFFICILE COLITIS (5 patients)
COLITIS (5 patients)
HYPERTENSION (5 patients)
MUSCLE SPASMS (5 patients)
COUGH (5 patients)
IMPAIRED SELF-CARE (5 patients)
CUTANEOUS VASCULITIS (5 patients)
CYSTITIS (5 patients)
INJURY (5 patients)

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