About this FactMed analysis covering adverse side effect reports of ABRAXANE patients who developed ACANTHOLYSIS.

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, 9 individuals taking ABRAXANE reported ACANTHOLYSIS to the FDA. A total of 2287 ABRAXANE 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 ABRAXANE and ACANTHOLYSIS. In doing so, we compare ABRAXANE with other drugs that cause ACANTHOLYSIS, to help you evaluate whether or not ABRAXANE causes ACANTHOLYSIS. Likewise, this page shows the most highly-reported side effects of ABRAXANE, so you can see if ACANTHOLYSIS ranks among ABRAXANE's most well-known side effects.
Summary Statistics
Reports of ABRAXANE causing ACANTHOLYSIS: 9
Reports of any side effect of ABRAXANE : 2287
Percentage of ABRAXANE patients where ACANTHOLYSIS is a reported side effect: 0.3935%

FDA reports of any drug causing ACANTHOLYSIS : 33
Average percentage for all medicated patients where ACANTHOLYSIS is reported as a complication: 0.0002%

Physician opinion on ABRAXANE as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing ABRAXANE:
BREAST CANCER METASTATIC ( 412 patients )
BREAST CANCER ( 349 patients )
NON-SMALL CELL LUNG CANCER ( 96 patients )
HEAD AND NECK CANCER ( 37 patients )
OVARIAN CANCER ( 34 patients )
METASTATIC MALIGNANT MELANOMA ( 34 patients )
PANCREATIC CARCINOMA ( 29 patients )
DRUG USE FOR UNKNOWN INDICATION ( 22 patients )
MALIGNANT MELANOMA ( 19 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 18 patients )
ADENOCARCINOMA PANCREAS ( 15 patients )
GASTRIC CANCER ( 12 patients )
TRANSITIONAL CELL CARCINOMA ( 9 patients )
OVARIAN CANCER RECURRENT ( 9 patients )
SQUAMOUS CELL CARCINOMA ( 8 patients )
CHEMOTHERAPY ( 8 patients )
NEOPLASM MALIGNANT ( 8 patients )
METASTASES TO BONE ( 7 patients )
RECURRENT CANCER ( 7 patients )
SQUAMOUS CELL CARCINOMA OF THE CERVIX ( 5 patients )
BLADDER CANCER ( 5 patients )
SMALL CELL LUNG CANCER EXTENSIVE STAGE ( 5 patients )
METASTASES TO LIVER ( 5 patients )
METASTASES TO LUNG ( 4 patients )
LUNG NEOPLASM MALIGNANT ( 4 patients )
OVARIAN CANCER METASTATIC ( 3 patients )
PANCREATIC CARCINOMA STAGE IV ( 3 patients )
UTERINE CANCER ( 3 patients )
SMALL CELL LUNG CANCER STAGE UNSPECIFIED ( 3 patients )
COLON CANCER METASTATIC ( 2 patients )
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED ( 2 patients )
DISEASE PROGRESSION ( 2 patients )
FALLOPIAN TUBE CANCER ( 2 patients )
METASTATIC NEOPLASM ( 2 patients )
NEOPLASM ( 2 patients )
INFLAMMATORY CARCINOMA OF THE BREAST ( 2 patients )
NEOPLASM RECURRENCE ( 2 patients )
BREAST CANCER STAGE IV ( 2 patients )
NON-SMALL CELL LUNG CANCER STAGE IV ( 2 patients )
DISEASE RECURRENCE ( 2 patients )
ADENOCARCINOMA ( 2 patients )
BREAST CANCER FEMALE ( 2 patients )
BREAST CANCER RECURRENT ( 2 patients )
CERVIX CARCINOMA ( 2 patients )
MALIGNANT NEOPLASM PROGRESSION ( 1 patients )
OROPHARYNGEAL CANCER STAGE UNSPECIFIED ( 1 patients )
METASTASES TO CENTRAL NERVOUS SYSTEM ( 1 patients )
OVARIAN EPITHELIAL CANCER ( 1 patients )
METASTATIC GASTRIC CANCER ( 1 patients )
GASTROINTESTINAL HAEMORRHAGE ( 1 patients )
RETROPERITONEAL CANCER ( 1 patients )
LUNG CANCER METASTATIC ( 1 patients )
OESOPHAGEAL CARCINOMA ( 1 patients )
TONGUE DISORDER ( 1 patients )
DEHYDRATION ( 1 patients )
TONSILLAR NEOPLASM ( 1 patients )
METASTASIS ( 1 patients )
ENDOMETRIAL CANCER ( 1 patients )
BILE DUCT CANCER ( 1 patients )
PERITONEAL MESOTHELIOMA MALIGNANT ( 1 patients )
BONE CANCER METASTATIC ( 1 patients )
METASTATIC UTERINE CANCER ( 1 patients )
LARYNGEAL CANCER ( 1 patients )
SMALL CELL CARCINOMA ( 1 patients )
OESOPHAGEAL ADENOCARCINOMA ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with ACANTHOLYSIS:

AMBIEN (10 patients)
ABRAXANE (9 patients)
ACIPHEX (9 patients)
AMPICILLIN (9 patients)
ASPIRIN (9 patients)
ATIVAN (9 patients)
AVASTIN (9 patients)
CYMBALTA (9 patients)
LEVOTHYROXINE SODIUM (9 patients)
NORCO (9 patients)
RADIATION (9 patients)
VICODIN (9 patients)
XELODA (9 patients)
ZOLOFT (9 patients)
ZOMETA (9 patients)
ZOFRAN (8 patients)
ARANESP (7 patients)
CAPECITABINE (7 patients)
CEFTRIAXONE (7 patients)
CEPHALEXIN (7 patients)
CIPROFLOXACIN (7 patients)
COLACE (7 patients)
DILAUDID (7 patients)
DOXIL (7 patients)
FEMARA (7 patients)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN (7 patients)
KEFLEX (7 patients)
LASIX (7 patients)
LORAZEPAM (7 patients)
NAPROSYN (7 patients)
NEULASTA (7 patients)
NIACIN (7 patients)
PERCOCET (7 patients)
PROVIGIL (7 patients)
RITALIN (7 patients)
SYNTHROID (7 patients)
TAXOTERE (7 patients)
VANCOMYCIN (7 patients)
VANCOMYCIN HCL (7 patients)
DEXAMETHASONE (6 patients)
FENTANYL (6 patients)
CYCLOSPORINE (4 patients)
PLAVIX (4 patients)
RELAFEN (4 patients)
ACETYLSALICYLIC ACID SRT (3 patients)
ACYCLOVIR (3 patients)
AMITIZA (3 patients)
NABUMETONE (3 patients)
NEXIUM (3 patients)
NIFEDIPINE (3 patients)
XIFAXAN (3 patients)
ALDACTAZIDE (2 patients)
AMLOR (2 patients)
AZATHIOPRINE (2 patients)
CLINDAMYCIN (2 patients)
COZAAR (2 patients)
DEPAKENE (2 patients)
DEPAS (2 patients)
DIGOXIN (2 patients)
DIPYRIDAMOL (2 patients)
EMPYNASE (2 patients)
ENALAPRIL MALEATE (2 patients)
ETRETINATE (2 patients)
FRACTAL (2 patients)
FUCIDIN CREAM (2 patients)
FUROSEMIDE (2 patients)
GAMUNEX (2 patients)
GLUCOR (2 patients)
HALCION (2 patients)
ISOSORBIDE MONONITRATE (2 patients)
LAMICTAL (2 patients)
LAXOBERON (2 patients)
LEVEMIR (2 patients)
MAGLAX (2 patients)
METHYLPREDNISOLONE (2 patients)
MINOCYCLIN (2 patients)
MOPRAL (2 patients)
MORPHINE (2 patients)
NITROGLYCERIN (2 patients)
PREDNISOLONE (2 patients)
PREDNISONE (2 patients)
SECTRAL (2 patients)
STILNOX (2 patients)
THEOPHYLLINE (2 patients)
TOPICAL ANTISEPTICS (2 patients)
ACENOCOUMAROL (1 patients)
ACENOCOUMAROL (ACENOCOUMAROL) (1 patients)
ACTIFED (1 patients)
AMILORIDE (1 patients)
AMILORIDE (AMILORIDE HYDROCHLORIDE) (1 patients)
ARNESP (1 patients)
ATENOLOL (1 patients)
ATORVASTATIN CALCIUM (1 patients)
BEMYLID (1 patients)
BETAMETHASONE DIPROPIIONATE (1 patients)
BETAMETHASONE DIPROPIONATE (1 patients)
CARBAMAZEPINE (1 patients)
CEFIXIME (1 patients)
CILAZAPRIL (1 patients)
CIPROFLOXACIN HCL (1 patients)
CIPROFLOXACIN IV (1 patients)
CISPLATIN (1 patients)
COPEGUS (1 patients)
DEXAMETHASONE ACETATE (1 patients)
DOXIUM (CALCIUM DOBESILATE) (1 patients)
ETHYOL (1 patients)
ETOPOSIDE (1 patients)
FENTANYL-100 (1 patients)
FILGRASTIM (FILGRASTIM) (1 patients)
FINASTERIDE (1 patients)
GEMZAR (1 patients)
GLIBENCLAMIDE (1 patients)
GLIMEPIRIDE (1 patients)
HEMERAN GEL (HEPARINOID) (1 patients)
HUMAN INSULIN (1 patients)
INSULIN ACTRAPID HUMAN (1 patients)
INTRON A (1 patients)
IRINOTECAN HCL (1 patients)
L-THYROXIN (1 patients)
LACIDIPINE (1 patients)
LACIDIPINE (LACIDIPINE) (1 patients)
MAGNESIUM OXIDE (MAGNESIUM OXIDE) (1 patients)
METHOTREXATE (1 patients)
MS CONTIN (1 patients)
OXYCODONE HCL (1 patients)
PEG-INTRON (1 patients)
PHENYTOIN (1 patients)
PRAVASTATIN (1 patients)
PRAVASTATIN SODIUM (1 patients)
PREDNISONE TAB (1 patients)
RADIATION THERAPY (1 patients)
REBETOL (1 patients)
RIBAVIRIN (1 patients)
TAREG (1 patients)
TOPICAL MEDICATIONS (FOR PSORIASIS) (1 patients)
ZETIA (1 patients)
Most common side effects for patients taking ABRAXANE:
PAIN (244 patients)
NAUSEA (236 patients)
DIARRHOEA (221 patients)
DEATH (217 patients)
ANAEMIA (216 patients)
WHITE BLOOD CELL COUNT DECREASED (190 patients)
FATIGUE (187 patients)
ANXIETY (181 patients)
PYREXIA (176 patients)
PLEURAL EFFUSION (172 patients)
DYSPNOEA (165 patients)
OSTEONECROSIS OF JAW (163 patients)
NEUTROPENIA (161 patients)
DEHYDRATION (159 patients)
NEUROPATHY PERIPHERAL (153 patients)
VOMITING (151 patients)
METASTASES TO BONE (149 patients)
BONE DISORDER (144 patients)
OSTEOMYELITIS (143 patients)
PNEUMONIA (136 patients)
ASTHENIA (133 patients)
NEUTROPHIL COUNT DECREASED (132 patients)
DECREASED APPETITE (131 patients)
BACK PAIN (117 patients)
ABDOMINAL PAIN (116 patients)
METASTASES TO LIVER (114 patients)
FEBRILE NEUTROPENIA (112 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (107 patients)
SEPSIS (107 patients)
PAIN IN JAW (104 patients)
DEPRESSION (103 patients)
INFECTION (101 patients)
HAEMOGLOBIN DECREASED (98 patients)
EMOTIONAL DISTRESS (98 patients)
STOMATITIS (97 patients)
ARTHRALGIA (97 patients)
ALOPECIA (96 patients)
MUCOSAL INFLAMMATION (96 patients)
METASTASES TO CENTRAL NERVOUS SYSTEM (94 patients)
INJURY (94 patients)
ATELECTASIS (92 patients)
CONSTIPATION (91 patients)
OSTEONECROSIS (89 patients)
BONE PAIN (89 patients)
THROMBOCYTOPENIA (88 patients)
METASTASES TO SPINE (86 patients)
WEIGHT DECREASED (86 patients)
DENTAL CARIES (85 patients)
CELLULITIS (85 patients)
METASTASES TO LUNG (85 patients)
HEADACHE (84 patients)
OEDEMA PERIPHERAL (81 patients)
ANHEDONIA (80 patients)
ASCITES (79 patients)
BREAST CANCER METASTATIC (78 patients)
GASTROOESOPHAGEAL REFLUX DISEASE (77 patients)
CHEST PAIN (77 patients)
CONFUSIONAL STATE (76 patients)
TOOTH EXTRACTION (75 patients)
SYNCOPE (74 patients)
PLATELET COUNT DECREASED (74 patients)
DEFORMITY (73 patients)
OSTEOARTHRITIS (70 patients)
ALANINE AMINOTRANSFERASE INCREASED (69 patients)
GAIT DISTURBANCE (68 patients)
MYALGIA (68 patients)
HYPOPHAGIA (68 patients)
HYPERTENSION (67 patients)
BONE LESION (67 patients)
SPINAL OSTEOARTHRITIS (66 patients)
TACHYCARDIA (66 patients)
IMPAIRED HEALING (65 patients)
PARAESTHESIA (65 patients)
HYPOTENSION (65 patients)
HYPOAESTHESIA (64 patients)
DEEP VEIN THROMBOSIS (64 patients)
DYSPHAGIA (63 patients)
BRONCHITIS (63 patients)
RENAL FAILURE ACUTE (62 patients)
RASH (62 patients)
BLOOD ALKALINE PHOSPHATASE INCREASED (62 patients)
PURULENT DISCHARGE (61 patients)
DIZZINESS (61 patients)
DISEASE PROGRESSION (59 patients)
NEOPLASM MALIGNANT (59 patients)
CHILLS (57 patients)
SWELLING (57 patients)
ORAL CANDIDIASIS (57 patients)
DECREASED INTEREST (57 patients)
FALL (56 patients)
ORAL PAIN (56 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (56 patients)
OSTEOPENIA (56 patients)
CARDIAC FAILURE CONGESTIVE (53 patients)
VISION BLURRED (51 patients)
MALIGNANT NEOPLASM PROGRESSION (51 patients)
DYSURIA (51 patients)
URINARY TRACT INFECTION (51 patients)
HYPOKALAEMIA (51 patients)
HEPATIC STEATOSIS (50 patients)
INTERVERTEBRAL DISC PROTRUSION (50 patients)
UPPER RESPIRATORY TRACT INFECTION (50 patients)
TOOTH LOSS (50 patients)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (49 patients)
CYST (48 patients)
CHRONIC SINUSITIS (48 patients)
LUNG NEOPLASM (48 patients)
PAIN IN EXTREMITY (47 patients)
COUGH (46 patients)
C-REACTIVE PROTEIN INCREASED (45 patients)
PULMONARY EMBOLISM (45 patients)
MACULAR OEDEMA (44 patients)
EPISTAXIS (44 patients)
MUSCULAR WEAKNESS (44 patients)
LOSS OF CONSCIOUSNESS (44 patients)
HAEMORRHOIDS (44 patients)
ERYTHEMA (44 patients)
HEART RATE INCREASED (43 patients)
MALAISE (43 patients)
OEDEMA (42 patients)
INTERSTITIAL LUNG DISEASE (42 patients)
HYDRONEPHROSIS (41 patients)
GASTRITIS (41 patients)
RENAL CYST (41 patients)
LOOSE TOOTH (40 patients)
HEPATIC CYST (40 patients)
JAW FRACTURE (40 patients)
DYSGEUSIA (40 patients)
TRICUSPID VALVE INCOMPETENCE (39 patients)
PANCYTOPENIA (39 patients)
UNRESPONSIVE TO STIMULI (39 patients)
PRIMARY SEQUESTRUM (38 patients)
GINGIVITIS (38 patients)
CONVULSION (37 patients)
BREAST CANCER RECURRENT (37 patients)
BLOOD GLUCOSE INCREASED (37 patients)
MASS (37 patients)
DISCOMFORT (36 patients)
PERICARDIAL EFFUSION (36 patients)
MENTAL STATUS CHANGES (36 patients)
TOOTH ABSCESS (36 patients)
EAR PAIN (36 patients)
SPINAL COMPRESSION FRACTURE (36 patients)
DEVICE RELATED INFECTION (36 patients)
LEUKOPENIA (36 patients)
NEOPLASM PROGRESSION (36 patients)
HERPES SIMPLEX (35 patients)
INSOMNIA (35 patients)
FISTULA (35 patients)
MALIGNANT PLEURAL EFFUSION (35 patients)
SPONDYLOLISTHESIS (34 patients)
ONYCHOMYCOSIS (34 patients)
TOOTHACHE (34 patients)
NECK PAIN (34 patients)
TREMOR (33 patients)
WHEELCHAIR USER (33 patients)
BLOOD BILIRUBIN INCREASED (33 patients)
BLOOD CREATININE INCREASED (33 patients)
HIATUS HERNIA (32 patients)
INFLAMMATION (32 patients)
CARDIOMEGALY (32 patients)
PATHOLOGICAL FRACTURE (32 patients)
PNEUMOTHORAX (32 patients)
ASPIRATION PLEURAL CAVITY (32 patients)
EXPOSED BONE IN JAW (32 patients)
RIB FRACTURE (31 patients)
DECUBITUS ULCER (31 patients)
HYPONATRAEMIA (31 patients)
OSTEOSCLEROSIS (30 patients)
ATRIAL FIBRILLATION (30 patients)
HEPATIC FUNCTION ABNORMAL (30 patients)
URINARY RETENTION (30 patients)
SEPTIC SHOCK (30 patients)
PERIPHERAL SENSORY NEUROPATHY (30 patients)
ORAL DISORDER (30 patients)
DYSPEPSIA (29 patients)
DRY MOUTH (29 patients)
BREAST CANCER (29 patients)
LUNG INFILTRATION (29 patients)
AORTIC ARTERIOSCLEROSIS (29 patients)
SINUS DISORDER (29 patients)
SWELLING FACE (29 patients)
HYPOXIA (29 patients)
MUSCULOSKELETAL PAIN (28 patients)
EJECTION FRACTION DECREASED (28 patients)
PNEUMONITIS (28 patients)
COLITIS (28 patients)
UTERINE LEIOMYOMA (28 patients)
DYSPNOEA EXERTIONAL (28 patients)
CENTRAL VENOUS CATHETERISATION (27 patients)
LIFE EXPECTANCY SHORTENED (27 patients)
HYPERKALAEMIA (27 patients)
SKIN LESION (27 patients)
ABSCESS (26 patients)
HEPATIC CIRRHOSIS (26 patients)
RENAL FAILURE (26 patients)
METASTATIC NEOPLASM (26 patients)
GAMMA-GLUTAMYLTRANSFERASE INCREASED (26 patients)
LACRIMATION INCREASED (26 patients)
ENDODONTIC PROCEDURE (26 patients)
RESPIRATORY FAILURE (25 patients)
SUBCUTANEOUS ABSCESS (25 patients)
NAIL DISORDER (25 patients)
LEUKOCYTOSIS (25 patients)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (25 patients)
MASTICATION DISORDER (25 patients)
LYMPHADENOPATHY (25 patients)
DYSPHONIA (25 patients)
OSTEOPOROSIS (25 patients)
GASTROINTESTINAL HAEMORRHAGE (25 patients)

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Recent FactMed Activity for ABRAXANE


Issue Description / Topic Timestamp
QUESTION
WOUND COMPLICATION
my father had pancreatic cancer and was on abraxane , but just now he must be operated due to acute cholesystitis , do you think there is any contraindication for him surgery? 2014-12-04 16:20:34
QUESTION
ABSCESS INTESTINAL
My husband was diagnosed with bladder cancer 3 years ago. He had many treatments including having his bladder removed. After about 6 months in remission he developed a blockage in the intestines which was the cancer and had a double bypass surgery to clear the blockage . He has been on Abraxane for 3 months and now getting a scan. How does the Abraxane work for this? 2015-02-18 08:00:37

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