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

About this FactMed analysis covering adverse side effect reports of ABACAVIR 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, 40 individuals taking ABACAVIR reported myopathy to the FDA. A total of 2089 ABACAVIR 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 ABACAVIR and myopathy. In doing so, we compare ABACAVIR with other drugs that cause myopathy, to help you evaluate whether or not ABACAVIR causes myopathy. Likewise, this page shows the most highly-reported side effects of ABACAVIR, so you can see if myopathy ranks among ABACAVIR's most well-known side effects.

Summary Statistics
Reports of ABACAVIR causing myopathy: 40
Reports of any side effect of ABACAVIR : 2089
Percentage of ABACAVIR patients where myopathy is a reported side effect: 1.9148%

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 ABACAVIR as adverse event culprit:

Overall opinion for all reports of this drug:

Most frequent diagnoses/indications for prescribing ABACAVIR:

HIV INFECTION ( 1179 patients )
DRUG USE FOR UNKNOWN INDICATION ( 106 patients )
ANTIRETROVIRAL THERAPY ( 104 patients )
DRUG EXPOSURE DURING PREGNANCY ( 49 patients )
ACQUIRED IMMUNODEFICIENCY SYNDROME ( 27 patients )
RETROVIRAL INFECTION ( 25 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 19 patients )
HIV TEST POSITIVE ( 13 patients )
SYSTEMIC ANTIVIRAL TREATMENT ( 11 patients )
BLOOD HIV RNA ( 7 patients )
HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION ( 6 patients )
MATERNAL EXPOSURE DURING PREGNANCY ( 6 patients )
PROPHYLAXIS ( 6 patients )
PROPHYLAXIS AGAINST HIV INFECTION ( 5 patients )
ANTIVIRAL TREATMENT ( 4 patients )
VIRAL INFECTION ( 4 patients )
HIV INFECTION CDC CATEGORY C3 ( 3 patients )
LIPOATROPHY ( 2 patients )
ACUTE HIV INFECTION ( 2 patients )
SUICIDE ATTEMPT ( 2 patients )
URTICARIA ( 2 patients )
IMMUNODEFICIENCY ( 2 patients )
END STAGE AIDS ( 2 patients )
ANTI-INFECTIVE THERAPY ( 1 patients )
ANTIVIRAL PROPHYLAXIS ( 1 patients )
AUTOIMMUNE DISORDER ( 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 ABACAVIR:

PYREXIA (231 patients)
DIARRHOEA (229 patients)
NAUSEA (167 patients)
VOMITING (154 patients)
ANAEMIA (144 patients)
DRUG INTERACTION (124 patients)
RASH (120 patients)
DRUG EXPOSURE DURING PREGNANCY (99 patients)
HEADACHE (97 patients)
ASTHENIA (89 patients)
DYSPNOEA (89 patients)
LIPODYSTROPHY ACQUIRED (88 patients)
ABDOMINAL PAIN (87 patients)
MALAISE (87 patients)
COUGH (86 patients)
FATIGUE (83 patients)
RENAL FAILURE ACUTE (80 patients)
IMMUNE RECONSTITUTION SYNDROME (79 patients)
WEIGHT DECREASED (76 patients)
HYPERLIPIDAEMIA (75 patients)
RENAL IMPAIRMENT (71 patients)
DRUG INEFFECTIVE (70 patients)
DRUG TOXICITY (69 patients)
ALANINE AMINOTRANSFERASE INCREASED (68 patients)
JAUNDICE (63 patients)
HYPERTENSION (61 patients)
MYOCARDIAL INFARCTION (60 patients)
MYALGIA (60 patients)
HYPERSENSITIVITY (60 patients)
NEUTROPENIA (58 patients)
RENAL FAILURE (56 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (55 patients)
BLOOD BILIRUBIN INCREASED (51 patients)
DRUG HYPERSENSITIVITY (50 patients)
HEPATIC FUNCTION ABNORMAL (50 patients)
CACHEXIA (49 patients)
NEUROPATHY PERIPHERAL (48 patients)
COAGULATION TIME PROLONGED (48 patients)
LYMPHADENOPATHY (47 patients)
CONTUSION (46 patients)
PREMATURE BABY (46 patients)
PANCYTOPENIA (45 patients)
BLOOD TRIGLYCERIDES INCREASED (45 patients)
RHABDOMYOLYSIS (44 patients)
DIZZINESS (42 patients)
SEPSIS (42 patients)
PRURITUS (42 patients)
LIVER DISORDER (42 patients)
ORAL CANDIDIASIS (42 patients)
HAEMOGLOBIN DECREASED (41 patients)
DRUG RESISTANCE (40 patients)
LIVER FUNCTION TEST ABNORMAL (40 patients)
DISEASE RECURRENCE (40 patients)
MYOPATHY (40 patients)
LACTIC ACIDOSIS (39 patients)
HEPATIC FAILURE (37 patients)
THROMBOCYTOPENIA (37 patients)
PHARYNGITIS (37 patients)
CHOLESTASIS (37 patients)
HYPOKALAEMIA (36 patients)
WHITE BLOOD CELL COUNT DECREASED (36 patients)
CHEST PAIN (36 patients)
OSTEONECROSIS (36 patients)
PNEUMONIA (36 patients)
DEATH (35 patients)
OEDEMA PERIPHERAL (35 patients)
BRADYCARDIA (34 patients)
BLOOD ALKALINE PHOSPHATASE INCREASED (34 patients)
BLOOD URIC ACID INCREASED (34 patients)
ABDOMINAL PAIN UPPER (33 patients)
DECREASED APPETITE (33 patients)
CARDIAC FAILURE (33 patients)
HYPOTENSION (32 patients)
PAIN (32 patients)
HEPATIC ENCEPHALOPATHY (31 patients)
NEPHROTIC SYNDROME (31 patients)
PRODUCTIVE COUGH (31 patients)
DEPRESSION (30 patients)
PANCREATITIS (30 patients)
HIV INFECTION (30 patients)
VIRAL LOAD INCREASED (29 patients)
PALLOR (29 patients)
LIPOATROPHY (28 patients)
TACHYCARDIA (28 patients)
GAMMA-GLUTAMYLTRANSFERASE INCREASED (28 patients)
PAIN IN EXTREMITY (28 patients)
CLEFT LIP AND PALATE (28 patients)
OESOPHAGEAL CANDIDIASIS (28 patients)
CHILLS (28 patients)
BLOOD CREATINE PHOSPHOKINASE INCREASED (28 patients)
HYPERLACTACIDAEMIA (28 patients)
PROTEINURIA (28 patients)
ACUTE HEPATIC FAILURE (27 patients)
GASTROINTESTINAL DISORDER (27 patients)
AIDS ENCEPHALOPATHY (27 patients)
HEPATIC CIRRHOSIS (27 patients)
ARTHRALGIA (27 patients)
LOSS OF CONSCIOUSNESS (27 patients)
HEPATOMEGALY (27 patients)
CONVULSION (26 patients)
SEPTIC SHOCK (26 patients)
NERVOUS SYSTEM DISORDER (26 patients)
RASH GENERALISED (25 patients)
HYPOAESTHESIA (25 patients)
HEPATITIS (25 patients)
CONDITION AGGRAVATED (25 patients)
SOMNOLENCE (25 patients)
PLATELET COUNT DECREASED (25 patients)
BLOOD CREATININE INCREASED (25 patients)
CONFUSIONAL STATE (24 patients)
TRANSPLANT REJECTION (24 patients)
CAESAREAN SECTION (24 patients)
BLOOD AMYLASE INCREASED (24 patients)
PREGNANCY (24 patients)
DIABETES MELLITUS (23 patients)
GUILLAIN-BARRE SYNDROME (23 patients)
PARAESTHESIA (23 patients)
TRANSAMINASES INCREASED (23 patients)
PORTAL HYPERTENSION (23 patients)
MITOCHONDRIAL TOXICITY (23 patients)
NEPHROLITHIASIS (23 patients)
ABORTION SPONTANEOUS (22 patients)
MELAENA (22 patients)
FANCONI SYNDROME ACQUIRED (22 patients)
BACK PAIN (22 patients)
HEPATIC ENZYME INCREASED (22 patients)
CARDIO-RESPIRATORY ARREST (22 patients)
CD4 LYMPHOCYTES DECREASED (22 patients)
MENTAL DISORDER (22 patients)
GRAFT DYSFUNCTION (21 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (21 patients)
PALPITATIONS (21 patients)
UPPER RESPIRATORY TRACT INFECTION (21 patients)
CYTOMEGALOVIRUS CHORIORETINITIS (21 patients)
PANCREATITIS ACUTE (21 patients)
GASTRIC ULCER (21 patients)
COGNITIVE DISORDER (21 patients)
INFLUENZA LIKE ILLNESS (21 patients)
ARRHYTHMIA (21 patients)
INSOMNIA (21 patients)
ASCITES (21 patients)
HYPERTRIGLYCERIDAEMIA (21 patients)
BLOOD LACTATE DEHYDROGENASE INCREASED (21 patients)
NEPHRITIS INTERSTITIAL (20 patients)
OCULAR ICTERUS (20 patients)
OSTEOPOROSIS (20 patients)
DIPLOPIA (20 patients)
SPLENOMEGALY (20 patients)
METABOLIC ACIDOSIS (20 patients)
RESPIRATORY FAILURE (19 patients)
AGITATION (19 patients)
HERPES ZOSTER (19 patients)
HYPERHIDROSIS (18 patients)
EYELID PTOSIS (18 patients)
CHOLELITHIASIS (18 patients)
GAIT DISTURBANCE (18 patients)
ANOREXIA (18 patients)
URINARY TRACT INFECTION (18 patients)
TREATMENT NONCOMPLIANCE (18 patients)
BLOOD HIV RNA INCREASED (18 patients)
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (17 patients)
STOMATITIS (17 patients)
LIVER TRANSPLANT (17 patients)
HEART RATE INCREASED (17 patients)
VISION BLURRED (17 patients)
KAPOSI'S SARCOMA (17 patients)
BLOOD LACTIC ACID INCREASED (17 patients)
MITOCHONDRIAL CYTOPATHY (17 patients)
TREMOR (16 patients)
DEHYDRATION (16 patients)
DYSLIPIDAEMIA (16 patients)
HAEMATEMESIS (16 patients)
JOINT DISLOCATION (16 patients)
PROTHROMBIN TIME PROLONGED (16 patients)
BRAIN OEDEMA (16 patients)
BRONCHOPNEUMONIA (16 patients)
DISTURBANCE IN ATTENTION (16 patients)
MULTI-ORGAN FAILURE (16 patients)
TUBERCULOSIS (16 patients)
ABDOMINAL DISTENSION (15 patients)
ABNORMAL DREAMS (15 patients)
VIRAL MUTATION IDENTIFIED (15 patients)
HYPOXIA (15 patients)
RASH PAPULAR (15 patients)
ACUTE MYOCARDIAL INFARCTION (15 patients)
STEVENS-JOHNSON SYNDROME (15 patients)
ADRENAL INSUFFICIENCY (15 patients)
HEPATIC STEATOSIS (15 patients)
NEPHROPATHY TOXIC (15 patients)
PROGRESSIVE EXTERNAL OPHTHALMOPLEGIA (15 patients)
PAIN IN JAW (15 patients)
APPENDICITIS (15 patients)
BACTERAEMIA (15 patients)
RENAL TUBULAR DISORDER (15 patients)
OVERDOSE (15 patients)
PNEUMOCYSTIS JIROVECI PNEUMONIA (14 patients)
FEBRILE NEUTROPENIA (14 patients)
MATERNAL DRUGS AFFECTING FOETUS (14 patients)
MUCOSAL DISCOLOURATION (14 patients)
UROSEPSIS (14 patients)
OESOPHAGEAL VARICES HAEMORRHAGE (14 patients)
PREMATURE RUPTURE OF MEMBRANES (14 patients)
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (14 patients)
RASH MACULO-PAPULAR (14 patients)
SWELLING FACE (14 patients)
MICROCYTIC ANAEMIA (13 patients)
RENAL FAILURE CHRONIC (13 patients)
GASTRITIS (13 patients)
HEPATOTOXICITY (13 patients)
OXYGEN SATURATION DECREASED (13 patients)

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Recent FactMed Activity for ABACAVIR

Issue	Description / Topic	Timestamp
QUESTION VENTRICULAR TACHYCARDIA	47-year-old admitted to the ICU with signs of hemodynamic collapse, confirming the sustained monomorphic ventricular tachycardia. Electrical cardioversion successful outcome indicated. The patient is being treated with anti retrovilar abacavir and efavirenz. His father died suddenly at age 48. The patient had no history of cardiovascular records. His physical examination is normal and his electrocardiogram is normal (normal QTc). The echocardiogram is normal. Coronary angiography are normal coronary indicated. I would like to know the possible relationship of this event to the drug abacavir.	2016-09-29 15:25:22

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