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

About this FactMed analysis covering adverse side effect reports of SEBIVO 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, 49 individuals taking SEBIVO reported myopathy to the FDA. A total of 540 SEBIVO 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 SEBIVO and myopathy. In doing so, we compare SEBIVO with other drugs that cause myopathy, to help you evaluate whether or not SEBIVO causes myopathy. Likewise, this page shows the most highly-reported side effects of SEBIVO, so you can see if myopathy ranks among SEBIVO's most well-known side effects.

Summary Statistics
Reports of SEBIVO causing myopathy: 49
Reports of any side effect of SEBIVO : 540
Percentage of SEBIVO patients where myopathy is a reported side effect: 9.0741%

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 SEBIVO as adverse event culprit:

Overall opinion for all reports of this drug:

Most frequent diagnoses/indications for prescribing SEBIVO:

HEPATITIS B ( 345 patients )
HEPATITIS ( 12 patients )
HEPATIC CIRRHOSIS ( 9 patients )
HEPATITIS B SURFACE ANTIGEN ( 7 patients )
CHRONIC HEPATITIS ( 3 patients )
HEPATITIS B SURFACE ANTIGEN POSITIVE ( 3 patients )
HEPATITIS C ( 2 patients )
PARVOVIRUS INFECTION ( 2 patients )
VIRAL HEPATITIS CARRIER ( 2 patients )
HEPATITIS B CORE ANTIGEN POSITIVE ( 2 patients )
HEPATITIS B POSITIVE ( 2 patients )
HEPATIC NEOPLASM MALIGNANT ( 2 patients )
HEPATITIS B E ANTIGEN POSITIVE ( 2 patients )
HIV INFECTION ( 1 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 1 patients )
ANTIVIRAL TREATMENT ( 1 patients )
VIRAL LOAD INCREASED ( 1 patients )
DRUG USE FOR UNKNOWN INDICATION ( 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 SEBIVO:

BLOOD CREATINE PHOSPHOKINASE INCREASED (209 patients)
MYALGIA (147 patients)
FATIGUE (110 patients)
MYOGLOBIN BLOOD INCREASED (108 patients)
MUSCULAR WEAKNESS (104 patients)
BLOOD LACTATE DEHYDROGENASE INCREASED (94 patients)
PAIN IN EXTREMITY (86 patients)
RHABDOMYOLYSIS (83 patients)
VOMITING (81 patients)
BLOOD LACTIC ACID INCREASED (80 patients)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED (78 patients)
NAUSEA (78 patients)
LACTIC ACIDOSIS (76 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (70 patients)
GAIT DISTURBANCE (70 patients)
ASTHENIA (61 patients)
DYSPNOEA (57 patients)
DEATH (55 patients)
OEDEMA PERIPHERAL (52 patients)
NEUROPATHY PERIPHERAL (50 patients)
DRUG EXPOSURE DURING PREGNANCY (50 patients)
RENAL IMPAIRMENT (49 patients)
MYOPATHY (49 patients)
BLOOD UREA INCREASED (47 patients)
GASTRITIS (46 patients)
ALANINE AMINOTRANSFERASE INCREASED (45 patients)
BLOOD URIC ACID INCREASED (45 patients)
HYPOAESTHESIA (44 patients)
MUSCLE ATROPHY (43 patients)
HEPATITIS B (39 patients)
WEIGHT DECREASED (37 patients)
CHEST DISCOMFORT (36 patients)
PALPITATIONS (36 patients)
OLIGURIA (35 patients)
PAIN (34 patients)
ELECTROLYTE IMBALANCE (34 patients)
HEART RATE INCREASED (33 patients)
METABOLIC ACIDOSIS (33 patients)
ABDOMINAL PAIN UPPER (32 patients)
MUSCULOSKELETAL STIFFNESS (32 patients)
CHROMATURIA (32 patients)
BLOOD GASES ABNORMAL (31 patients)
BLOOD PRESSURE DECREASED (31 patients)
HEPATITIS B DNA INCREASED (31 patients)
TACHYPNOEA (29 patients)
CAESAREAN SECTION (29 patients)
MULTI-ORGAN FAILURE (29 patients)
ACID BASE BALANCE ABNORMAL (28 patients)
HYPOPHAGIA (28 patients)
MYOSITIS (27 patients)
NORMAL NEWBORN (27 patients)
RENAL FAILURE ACUTE (26 patients)
BLOOD BILIRUBIN INCREASED (26 patients)
DECREASED APPETITE (25 patients)
ABDOMINAL DISCOMFORT (22 patients)
HEPATIC CIRRHOSIS (21 patients)
LUNG INFECTION (20 patients)
JAUNDICE (20 patients)
DYSSTASIA (20 patients)
MUSCLE INJURY (20 patients)
FEELING ABNORMAL (19 patients)
ANURIA (19 patients)
ASCITES (19 patients)
MALAISE (18 patients)
BLOOD CREATININE INCREASED (18 patients)
ABASIA (17 patients)
ABDOMINAL PAIN (17 patients)
BACK PAIN (17 patients)
HAEMODIALYSIS (17 patients)
SHOCK (17 patients)
SLEEP DISORDER (16 patients)
LOSS OF CONSCIOUSNESS (16 patients)
ARTHRALGIA (16 patients)
VIRAL LOAD INCREASED (16 patients)
COMA (16 patients)
CSF PROTEIN INCREASED (16 patients)
MATERNAL EXPOSURE DURING PREGNANCY (16 patients)
MUSCLE SWELLING (15 patients)
SINUS TACHYCARDIA (14 patients)
PLEURAL EFFUSION (14 patients)
BLOOD PH DECREASED (14 patients)
RESPIRATORY RATE INCREASED (14 patients)
WHITE BLOOD CELL COUNT INCREASED (14 patients)
SOMNOLENCE (14 patients)
HYPOTENSION (13 patients)
FALL (12 patients)
BEDRIDDEN (12 patients)
PANCREATITIS (12 patients)
COUGH (12 patients)
MUSCLE DISORDER (12 patients)
ARRHYTHMIA (11 patients)
HEPATIC NEOPLASM MALIGNANT (11 patients)
COAGULOPATHY (11 patients)
DISEASE PROGRESSION (11 patients)
PYREXIA (11 patients)
ACIDOSIS (10 patients)
URINE KETONE BODY PRESENT (10 patients)
CIRCULATORY COLLAPSE (10 patients)
PARAESTHESIA (10 patients)
POLYNEUROPATHY (10 patients)
DRUG RESISTANCE (10 patients)
MECHANICAL VENTILATION (10 patients)
ACUTE HEPATIC FAILURE (9 patients)
ANOREXIA (9 patients)
RALES (9 patients)
BILIRUBIN CONJUGATED INCREASED (9 patients)
HYPOGLYCAEMIA (9 patients)
BLOOD URINE PRESENT (9 patients)
NERVE INJURY (9 patients)
JOINT SWELLING (9 patients)
HYPOKALAEMIA (9 patients)
RESPIRATORY FAILURE (9 patients)
ABDOMINAL INFECTION (8 patients)
ABORTION INDUCED (8 patients)
PULMONARY OEDEMA (8 patients)
HYPOTONIA (8 patients)
MYOCARDITIS (8 patients)
MOBILITY DECREASED (8 patients)
HEPATITIS (8 patients)
COAGULATION FACTOR XI LEVEL DECREASED (8 patients)
FOETAL EXPOSURE DURING PREGNANCY (8 patients)
DEPRESSION (8 patients)
LUNG DISORDER (8 patients)
LIVER DISORDER (7 patients)
ACUTE RESPIRATORY FAILURE (7 patients)
ALDOLASE ABNORMAL (7 patients)
PCO2 DECREASED (7 patients)
HEPATIC FAILURE (7 patients)
PROTEIN URINE PRESENT (7 patients)
GENERALISED OEDEMA (7 patients)
POLYMYOSITIS (7 patients)
GASTRIC HAEMORRHAGE (7 patients)
RENAL FAILURE (6 patients)
MYOGLOBINURIA (6 patients)
ALPHA HYDROXYBUTYRATE DEHYDROGENASE INCREASED (6 patients)
HYPOALBUMINAEMIA (6 patients)
AMYOTROPHY (6 patients)
ANAESTHESIA (6 patients)
PANCYTOPENIA (6 patients)
BALANCE DISORDER (6 patients)
OCULAR ICTERUS (6 patients)
BLOOD BILIRUBIN UNCONJUGATED INCREASED (6 patients)
PNEUMONIA (6 patients)
BLOOD CREATINE PHOSPHOKINASE MB ABNORMAL (6 patients)
HEPATIC NEOPLASM (6 patients)
HEPATITIS B SURFACE ANTIGEN POSITIVE (6 patients)
CARDIAC ARREST (6 patients)
SYNCOPE (6 patients)
NEURALGIA (6 patients)
HYPERKALAEMIA (6 patients)
URINE OUTPUT DECREASED (6 patients)
URINE BILIRUBIN INCREASED (6 patients)
OEDEMA (6 patients)
CONSTIPATION (6 patients)
PLATELET COUNT INCREASED (6 patients)
RED BLOOD CELL COUNT DECREASED (6 patients)
DIARRHOEA (6 patients)
PERIPHERAL COLDNESS (6 patients)
HAEMOPTYSIS (6 patients)
HEADACHE (6 patients)
ELECTROMYOGRAM ABNORMAL (6 patients)
NEUTROPHIL COUNT INCREASED (6 patients)
MUSCULAR DYSTROPHY (5 patients)
SURGERY (5 patients)
HEPATIC FUNCTION ABNORMAL (5 patients)
ALPHA 1 FOETOPROTEIN INCREASED (5 patients)
ANXIETY (5 patients)
AREFLEXIA (5 patients)
BASE EXCESS INCREASED (5 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (5 patients)
BLOOD BICARBONATE DECREASED (5 patients)
INTERSTITIAL LUNG DISEASE (5 patients)
BLOOD CREATINE PHOSPHOKINASE MB (5 patients)
BLOOD GLUCOSE DECREASED (5 patients)
BLOOD GLUCOSE INCREASED (5 patients)
BLOOD PRESSURE DIASTOLIC DECREASED (5 patients)
MUSCULOSKELETAL PAIN (5 patients)
RESPIRATORY ALKALOSIS (5 patients)
CARDIOPULMONARY FAILURE (5 patients)
CARDIOVASCULAR DISORDER (5 patients)
LIVER FUNCTION TEST ABNORMAL (5 patients)
DISSEMINATED INTRAVASCULAR COAGULATION (5 patients)
GASTROINTESTINAL DISORDER (5 patients)
DYSPHAGIA (5 patients)
GROIN PAIN (5 patients)
ABDOMINAL DISTENSION (4 patients)
ABDOMINAL TENDERNESS (4 patients)
INJECTION SITE SWELLING (4 patients)
LYMPHOCYTIC INFILTRATION (4 patients)
FULL BLOOD COUNT INCREASED (4 patients)
POOR QUALITY SLEEP (4 patients)
ASTERIXIS (4 patients)
ASTHMA (4 patients)
PERITONITIS BACTERIAL (4 patients)
PO2 INCREASED (4 patients)
HAEMOGLOBIN INCREASED (4 patients)
MUSCULOSKELETAL DISCOMFORT (4 patients)
RENAL DISORDER (4 patients)
BONE FORMATION INCREASED (4 patients)
MYALGIA INTERCOSTAL (4 patients)
C-REACTIVE PROTEIN INCREASED (4 patients)
HEPATIC ENCEPHALOPATHY (4 patients)
GAMMA-GLUTAMYLTRANSFERASE INCREASED (4 patients)
PREMATURE BABY (4 patients)
LEFT VENTRICULAR FAILURE (4 patients)
PROCTALGIA (4 patients)
LOCALISED OEDEMA (4 patients)
MARROW HYPERPLASIA (4 patients)
MOOD ALTERED (4 patients)
ENDOTRACHEAL INTUBATION (4 patients)

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Recent FactMed Activity for SEBIVO

Issue	Description / Topic	Timestamp
QUESTION PLATELET COUNT DECREASED	My father has been taking Sebivo 600mg and Tenophobir for viral hepatitis from last 3 years. His platelet count has come down to 85000. Is it because of Sebivo	2015-06-04 06:32:04

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