About this FactMed analysis covering adverse side effect reports of AEB071 patients who developed SEPSIS.

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, 1 individuals taking AEB071 reported SEPSIS to the FDA. A total of 37 AEB071 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 AEB071 and SEPSIS. In doing so, we compare AEB071 with other drugs that cause SEPSIS, to help you evaluate whether or not AEB071 causes SEPSIS. Likewise, this page shows the most highly-reported side effects of AEB071, so you can see if SEPSIS ranks among AEB071's most well-known side effects.
Summary Statistics
Reports of AEB071 causing SEPSIS: 1
Reports of any side effect of AEB071 : 37
Percentage of AEB071 patients where SEPSIS is a reported side effect: 2.7027%

FDA reports of any drug causing SEPSIS : 37701
Average percentage for all medicated patients where SEPSIS is reported as a complication: 0.2363%

Physician opinion on AEB071 as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing AEB071:
RENAL TRANSPLANT ( 34 patients )
( 0 patients )
Drugs with high FDA adverse event association with SEPSIS:

HEPARIN SODIUM INJECTION (4870 patients)
ASPIRIN (2809 patients)
METHOTREXATE (2492 patients)
PREDNISOLONE (2455 patients)
PREDNISONE (2336 patients)
REVLIMID (2034 patients)
LASIX (1956 patients)
DIANEAL (1901 patients)
REMICADE (1864 patients)
DEXAMETHASONE (1686 patients)
CYCLOPHOSPHAMIDE (1670 patients)
FUROSEMIDE (1543 patients)
HUMIRA (1519 patients)
OMEPRAZOLE (1421 patients)
FOLIC ACID (1361 patients)
ACETAMINOPHEN (1354 patients)
CYCLOSPORINE (1192 patients)
ALLOPURINOL (1142 patients)
CYTARABINE (1125 patients)
FOSAMAX (1097 patients)
VANCOMYCIN (1038 patients)
LISINOPRIL (1025 patients)
FLUOROURACIL (1015 patients)
ZOMETA (996 patients)
POTASSIUM CHLORIDE (989 patients)
NEXIUM (957 patients)
CISPLATIN (956 patients)
PREDNISONE TAB (941 patients)
SIMVASTATIN (934 patients)
DIGOXIN (927 patients)
LIPITOR (897 patients)
VIOXX (892 patients)
COUMADIN (890 patients)
AVONEX (853 patients)
MYCOPHENOLATE MOFETIL (848 patients)
ETOPOSIDE (845 patients)
CARBOPLATIN (798 patients)
PROTONIX (783 patients)
EXJADE (782 patients)
FLUCONAZOLE (776 patients)
MORPHINE (771 patients)
ALBUTEROL (755 patients)
ENBREL (755 patients)
TACROLIMUS (753 patients)
DOXORUBICIN HCL (750 patients)
OXYCONTIN (745 patients)
ZOFRAN (739 patients)
DECADRON (732 patients)
PROGRAF (720 patients)
NORVASC (712 patients)
VINCRISTINE (709 patients)
VELCADE (704 patients)
CIPROFLOXACIN (702 patients)
PLAVIX (687 patients)
NEORAL (684 patients)
ATIVAN (676 patients)
ACYCLOVIR (674 patients)
INSULIN (670 patients)
WARFARIN SODIUM (663 patients)
RITUXIMAB (662 patients)
ATENOLOL (659 patients)
TYSABRI (646 patients)
NEURONTIN (641 patients)
METHYLPREDNISOLONE (639 patients)
SYNTHROID (634 patients)
PRILOSEC (634 patients)
HEPARIN (630 patients)
NEUPOGEN (623 patients)
LANSOPRAZOLE (616 patients)
AMBIEN (604 patients)
LEVOTHYROXINE SODIUM (599 patients)
LEVAQUIN (595 patients)
LORAZEPAM (592 patients)
HEPARIN SODIUM (591 patients)
METOPROLOL TARTRATE (583 patients)
AMLODIPINE (582 patients)
IBUPROFEN (571 patients)
METFORMIN HCL (560 patients)
VIDAZA (560 patients)
FAMOTIDINE (558 patients)
HYDROCHLOROTHIAZIDE (551 patients)
FENTANYL (538 patients)
GABAPENTIN (533 patients)
LANTUS (526 patients)
DIFLUCAN (525 patients)
OXALIPLATIN (517 patients)
VICODIN (515 patients)
PANTOPRAZOLE (502 patients)
AREDIA (501 patients)
SOLU-MEDROL (494 patients)
ZOCOR (492 patients)
GOLIMUMAB (490 patients)
SOLIRIS (476 patients)
XANAX (476 patients)
EXTRANEAL (476 patients)
PAXIL (469 patients)
OXYCODONE HCL (461 patients)
TOPROL-XL (457 patients)
BACTRIM (453 patients)
ZOLOFT (452 patients)
PERCOCET (446 patients)
LOVENOX (445 patients)
THALOMID (445 patients)
RAMIPRIL (445 patients)
AVASTIN (439 patients)
MULTI-VITAMINS (436 patients)
METOCLOPRAMIDE (435 patients)
DOCETAXEL (435 patients)
VITAMIN D (432 patients)
BEVACIZUMAB (431 patients)
CAPECITABINE (430 patients)
LYRICA (425 patients)
AZATHIOPRINE (424 patients)
COREG (421 patients)
MEROPENEM (420 patients)
FLAGYL (419 patients)
PREDONINE (416 patients)
TRACLEER (412 patients)
PREVACID (407 patients)
TRAMADOL HCL (407 patients)
LACTULOSE (397 patients)
REGLAN (391 patients)
SPIRONOLACTONE (391 patients)
LEUCOVORIN CALCIUM (391 patients)
PARACETAMOL (386 patients)
XELODA (386 patients)
LEVOFLOXACIN (385 patients)
CELLCEPT (382 patients)
METRONIDAZOLE (382 patients)
NITROGLYCERIN (381 patients)
DIOVAN (378 patients)
HYDROCORTISONE (376 patients)
CLOZARIL (371 patients)
CELEBREX (370 patients)
VOLTAREN (370 patients)
ARANESP (370 patients)
TAXOTERE (369 patients)
EPOGEN (363 patients)
FORTEO (361 patients)
SEROQUEL (359 patients)
MYLOTARG (357 patients)
METOPROLOL (355 patients)
CALCIUM (355 patients)
THALIDOMIDE (354 patients)
DILAUDID (354 patients)
COLACE (353 patients)
ADVAIR DISKUS 100/50 (353 patients)
MAGNESIUM OXIDE (351 patients)
PACLITAXEL (351 patients)
ONDANSETRON (349 patients)
COMPAZINE (348 patients)
ROCEPHIN (340 patients)
RANITIDINE (338 patients)
LORTAB (336 patients)
VITAMIN B-12 (334 patients)
CLONAZEPAM (333 patients)
HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% (333 patients)
NYSTATIN (332 patients)
PEPCID (329 patients)
AMOXICILLIN (328 patients)
SPIRIVA (328 patients)
CALCIUM CARBONATE (327 patients)
MORPHINE SULFATE (326 patients)
ZOSYN (326 patients)
ALPRAZOLAM (324 patients)
DEXAMETHASONE TAB (324 patients)
ZANTAC (324 patients)
PANTOPRAZOLE SODIUM (320 patients)
LOPRESSOR (319 patients)
FERROUS SULFATE TAB (318 patients)
LEXAPRO (314 patients)
ENALAPRIL MALEATE (312 patients)
FLOMAX (312 patients)
BENADRYL (312 patients)
REBIF (311 patients)
CYMBALTA (311 patients)
ALDACTONE (308 patients)
TYLENOL (307 patients)
GLEEVEC (306 patients)
TOCILIZUMAB (304 patients)
CETUXIMAB (302 patients)
FLUDARABINE PHOSPHATE (301 patients)
CRESTOR (298 patients)
MULTI-VITAMIN (297 patients)
FLUDARA (292 patients)
SINGULAIR (291 patients)
ENOXAPARIN SODIUM (290 patients)
ALBUMIN (HUMAN) (287 patients)
GLIPIZIDE (285 patients)
SANDOSTATIN LAR (285 patients)
KYTRIL (283 patients)
ASCORBIC ACID (283 patients)
RIBAVIRIN (283 patients)
THYMOGLOBULIN (282 patients)
NPLATE (281 patients)
SODIUM CHLORIDE (279 patients)
NEULASTA (279 patients)
TYLENOL (CAPLET) (278 patients)
MABTHERA (276 patients)
DAUNORUBICIN HCL (276 patients)
IRON (275 patients)
AUGMENTIN '125' (274 patients)
GLYBURIDE (273 patients)
CLOZAPINE (272 patients)
CARVEDILOL (270 patients)
TAXOL (269 patients)
NEXAVAR (266 patients)
DIAZEPAM (263 patients)
MS CONTIN (261 patients)
ATROVENT (261 patients)
Most common side effects for patients taking AEB071:
VOMITING (6 patients)
NEPHROTIC SYNDROME (5 patients)
PROTEINURIA (5 patients)
ANOREXIA (4 patients)
ASTHENIA (4 patients)
DIZZINESS (4 patients)
FUNGAL OESOPHAGITIS (4 patients)
GASTRIC ULCER HAEMORRHAGE (4 patients)
GASTRITIS (4 patients)
KIDNEY TRANSPLANT REJECTION (4 patients)
NAUSEA (4 patients)
REFLUX OESOPHAGITIS (4 patients)
DIARRHOEA (3 patients)
DRUG INEFFECTIVE (3 patients)
ELECTROCARDIOGRAM QT PROLONGED (3 patients)
FEELING ABNORMAL (3 patients)
GLOMERULONEPHRITIS (3 patients)
HAEMOGLOBIN DECREASED (3 patients)
INCISION SITE PAIN (3 patients)
INSOMNIA (3 patients)
POST PROCEDURAL HAEMATOMA (3 patients)
PULMONARY EMBOLISM (3 patients)
ANURIA (2 patients)
BLOOD ALBUMIN DECREASED (2 patients)
CONSTIPATION (2 patients)
COUGH (2 patients)
DRUG INTERACTION (2 patients)
EAR PAIN (2 patients)
FATIGUE (2 patients)
FEBRILE NEUTROPENIA (2 patients)
GASTROENTERITIS (2 patients)
GASTROINTESTINAL INFECTION (2 patients)
HIATUS HERNIA (2 patients)
HYPOTENSION (2 patients)
IMMUNOSUPPRESSANT DRUG LEVEL INCREASED (2 patients)
INFECTION (2 patients)
NASAL CONGESTION (2 patients)
PHARYNGOLARYNGEAL PAIN (2 patients)
PNEUMOCOCCAL SEPSIS (2 patients)
PNEUMONIA (2 patients)
POST PROCEDURAL HAEMORRHAGE (2 patients)
PSEUDOMONAS INFECTION (2 patients)
PYREXIA (2 patients)
RENAL IMPAIRMENT (2 patients)
UPPER-AIRWAY COUGH SYNDROME (2 patients)
URINARY TRACT INFECTION (2 patients)
URINOMA (2 patients)
ABDOMINAL PAIN (1 patients)
AGEUSIA (1 patients)
ANAEMIA (1 patients)
BACTERIAL INFECTION (1 patients)
BLADDER CATHETER REMOVAL (1 patients)
BLADDER CATHETERISATION (1 patients)
BLADDER OPERATION (1 patients)
BLOOD POTASSIUM DECREASED (1 patients)
BLOOD POTASSIUM INCREASED (1 patients)
COAGULOPATHY (1 patients)
CYSTOSTOMY (1 patients)
DEATH (1 patients)
DECREASED APPETITE (1 patients)
DEHYDRATION (1 patients)
DYSLIPIDAEMIA (1 patients)
DYSPEPSIA (1 patients)
DYSPNOEA (1 patients)
ELECTROCARDIOGRAM ABNORMAL (1 patients)
FALL (1 patients)
GASTROINTESTINAL HAEMORRHAGE (1 patients)
HAEMORRHOIDS (1 patients)
HEPATIC FUNCTION ABNORMAL (1 patients)
HYPERCALCAEMIA (1 patients)
HYPERGLYCAEMIA (1 patients)
HYPOXIA (1 patients)
INFLAMMATION (1 patients)
INTERNATIONAL NORMALISED RATIO DECREASED (1 patients)
KIDNEY FIBROSIS (1 patients)
LYMPHATIC FISTULA (1 patients)
LYMPHOCELE (1 patients)
OCCULT BLOOD POSITIVE (1 patients)
OEDEMA (1 patients)
OEDEMA PERIPHERAL (1 patients)
PROTEIN TOTAL DECREASED (1 patients)
PROTHROMBIN TIME PROLONGED (1 patients)
PYELONEPHRITIS (1 patients)
RECTAL HAEMORRHAGE (1 patients)
RENAL ATROPHY (1 patients)
RENAL FAILURE ACUTE (1 patients)
RENAL TUBULAR NECROSIS (1 patients)
SCROTAL OEDEMA (1 patients)
SEPSIS (1 patients)
SEPTIC SHOCK (1 patients)
SHOCK HAEMORRHAGIC (1 patients)
SKIN LESION (1 patients)
SURGERY (1 patients)
TACHYCARDIA (1 patients)
TOXICITY TO VARIOUS AGENTS (1 patients)
URETHRAL DILATATION (1 patients)
URETHRAL OPERATION (1 patients)
URETHRAL STENOSIS (1 patients)
URINARY TRACT INFECTION PSEUDOMONAL (1 patients)
UROSTOMY (1 patients)
VESICOURETERAL REFLUX SURGERY (1 patients)
WEIGHT DECREASED (1 patients)
WEIGHT INCREASED (1 patients)

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