About this FactMed analysis covering adverse side effect reports of INCIVEK patients who developed ADRENALITIS.

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, 3 individuals taking INCIVEK reported ADRENALITIS to the FDA. A total of 5938 INCIVEK 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 INCIVEK and ADRENALITIS. In doing so, we compare INCIVEK with other drugs that cause ADRENALITIS, to help you evaluate whether or not INCIVEK causes ADRENALITIS. Likewise, this page shows the most highly-reported side effects of INCIVEK, so you can see if ADRENALITIS ranks among INCIVEK's most well-known side effects.
Summary Statistics
Reports of INCIVEK causing ADRENALITIS: 3
Reports of any side effect of INCIVEK : 5938
Percentage of INCIVEK patients where ADRENALITIS is a reported side effect: 0.0505%

FDA reports of any drug causing ADRENALITIS : 27
Average percentage for all medicated patients where ADRENALITIS is reported as a complication: 0.0002%

Physician opinion on INCIVEK as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing INCIVEK:
HEPATITIS C ( 3939 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 25 patients )
HEPATITIS ( 4 patients )
DISEASE RECURRENCE ( 1 patients )
DEPRESSION ( 1 patients )
HIV INFECTION ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with ADRENALITIS:

TRUVADA (7 patients)
VALGANCICLOVIR (6 patients)
DURAGESIC (6 patients)
METHOTREXATE (5 patients)
FOLIC ACID (5 patients)
ENBREL (5 patients)
BYETTA (4 patients)
COTRIM (4 patients)
FLUCONAZOLE (4 patients)
FAMOTIDINE (4 patients)
LOPINAVIR/RITONAVIR (3 patients)
URSODIOL (3 patients)
RIBAVIRIN (3 patients)
PEGASYS (3 patients)
AZITHROMYCIN (3 patients)
INCIVEK (3 patients)
DYAZIDE (2 patients)
VENOSTASIN (THIAMINE HYDROCHLORIDE, HORSE CHESTNUT EXTRACT) (2 patients)
VALGANCICLOVIR HCL (2 patients)
ADVAIR DISKUS 100/50 (2 patients)
SULFAMETHOXAZOLE AND TRIMETHOPRIM (2 patients)
DDAVP (2 patients)
FLOVENT (2 patients)
STEROIDS NOS (2 patients)
CYCLOSPORINE (2 patients)
GOLIMUMAB (2 patients)
SINGULAIR (2 patients)
BAKTAR (2 patients)
KALETRA (2 patients)
SEREVENT (2 patients)
LISINOPRIL (2 patients)
SANASTHMYL (BECLOMETASONE DIPROPIONATE) (2 patients)
LOPINAVIR AND RITONAVIR (2 patients)
ZOLOFT (2 patients)
METFORMIN HCL (2 patients)
AMITRIPTYLINE HYDROCHLORIDE (2 patients)
METOCLOPRAMIDE (2 patients)
MOVICOL (MACROGOL, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBO (2 patients)
NITROGLYCERIN (2 patients)
REGLAN (2 patients)
OXIS (FORMOTEROL) (2 patients)
PRILOSEC (2 patients)
ANTI-ASTHMATICS (2 patients)
OXYCODONE HCL (2 patients)
PANTOPRAZOLE SODIUM (2 patients)
OXYCODON KAPSELN 5MG(OXY IR CAPSULE 5 MG) (1 patients)
OXYCODON KAPSELN 5MG (OXY IR CAPSULE 5 MG)IR CAPSULE (1 patients)
RAMIPRIL (1 patients)
NORVIR (1 patients)
RETROVIR (1 patients)
AZITHROMYC (1 patients)
LOPINAVIR + RITONAVIR (LOPINAVIR + RITONAVIR) (1 patients)
SANDIMMUNE (1 patients)
LAMIVUDINE (1 patients)
IBUPROFEN (ADVIL) (1 patients)
DARUNAVIR ETHANOLATE (1 patients)
EPIVIR (1 patients)
DEPO-PROVERA (1 patients)
URSODEOXYCHOLIC ACID (1 patients)
ADRENOCORTICOTROPHIC HORMONE (1 patients)
ACETAMINOPHEN (1 patients)
EFFEXOR (1 patients)
EFALIZUMAB (1 patients)
ZIAGEN (1 patients)
ZIDOVUDINE (1 patients)
ABACAVIR (1 patients)
Most common side effects for patients taking INCIVEK:
NAUSEA (927 patients)
FATIGUE (785 patients)
RASH (679 patients)
ANAEMIA (678 patients)
VOMITING (523 patients)
PRURITUS (522 patients)
DIARRHOEA (518 patients)
ANORECTAL DISCOMFORT (466 patients)
HEADACHE (384 patients)
DYSPNOEA (332 patients)
PYREXIA (314 patients)
RASH GENERALISED (289 patients)
ASTHENIA (282 patients)
HAEMORRHOIDS (275 patients)
RASH PRURITIC (266 patients)
ANAL PRURITUS (251 patients)
DIZZINESS (248 patients)
WHITE BLOOD CELL COUNT DECREASED (238 patients)
DECREASED APPETITE (229 patients)
CHILLS (224 patients)
INSOMNIA (209 patients)
DRUG DOSE OMISSION (191 patients)
PAIN (189 patients)
INFLUENZA LIKE ILLNESS (182 patients)
DEHYDRATION (178 patients)
HAEMOGLOBIN DECREASED (161 patients)
PLATELET COUNT DECREASED (160 patients)
WEIGHT DECREASED (154 patients)
DYSGEUSIA (134 patients)
PROCTALGIA (129 patients)
PRURITUS GENERALISED (122 patients)
DEPRESSION (112 patients)
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (107 patients)
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION (105 patients)
OEDEMA PERIPHERAL (103 patients)
FEELING ABNORMAL (99 patients)
ANXIETY (94 patients)
COUGH (94 patients)
MALAISE (93 patients)
CONSTIPATION (92 patients)
ARTHRALGIA (86 patients)
CONFUSIONAL STATE (83 patients)
RECTAL HAEMORRHAGE (80 patients)
PNEUMONIA (79 patients)
LOSS OF CONSCIOUSNESS (76 patients)
BLISTER (75 patients)
DEATH (75 patients)
HAEMATOCHEZIA (74 patients)
RASH ERYTHEMATOUS (74 patients)
ABDOMINAL PAIN UPPER (72 patients)
RENAL FAILURE (71 patients)
DRUG INTOLERANCE (70 patients)
DRUG INEFFECTIVE (69 patients)
IRRITABILITY (69 patients)
SWELLING FACE (66 patients)
DRY SKIN (65 patients)
VISION BLURRED (65 patients)
STOMATITIS (64 patients)
SYNCOPE (64 patients)
RED BLOOD CELL COUNT DECREASED (63 patients)
HYPOTENSION (63 patients)
ABDOMINAL PAIN (62 patients)
ALOPECIA (62 patients)
CHEST PAIN (62 patients)
PANCREATITIS (60 patients)
MYALGIA (58 patients)
NEUTROPENIA (56 patients)
ABDOMINAL DISCOMFORT (55 patients)
DRY MOUTH (55 patients)
RASH PAPULAR (54 patients)
ADVERSE EVENT (52 patients)
EPISTAXIS (52 patients)
TREMOR (51 patients)
SEPSIS (50 patients)
PANCYTOPENIA (49 patients)
BACK PAIN (49 patients)
URTICARIA (48 patients)
BLOOD POTASSIUM DECREASED (48 patients)
DEPRESSED MOOD (48 patients)
INCORRECT DOSE ADMINISTERED (48 patients)
ABDOMINAL DISTENSION (47 patients)
SUICIDAL IDEATION (47 patients)
WEIGHT INCREASED (46 patients)
MEMORY IMPAIRMENT (45 patients)
SKIN EXFOLIATION (44 patients)
PAIN IN EXTREMITY (44 patients)
HAEMORRHOIDAL HAEMORRHAGE (44 patients)
SOMNOLENCE (43 patients)
DYSPEPSIA (42 patients)
THROMBOCYTOPENIA (41 patients)
MUSCLE SPASMS (41 patients)
OROPHARYNGEAL PAIN (40 patients)
DYSPHAGIA (39 patients)
HYPERHIDROSIS (37 patients)
MIGRAINE (36 patients)
OFF LABEL USE (36 patients)
HYPOAESTHESIA (35 patients)
HEART RATE INCREASED (35 patients)
HEPATIC CIRRHOSIS (35 patients)
BLOOD CREATININE INCREASED (35 patients)
GAIT DISTURBANCE (35 patients)
ERYTHEMA (34 patients)
STAPHYLOCOCCAL INFECTION (33 patients)
STEVENS-JOHNSON SYNDROME (32 patients)
BLOOD GLUCOSE INCREASED (32 patients)
INCORRECT DRUG ADMINISTRATION DURATION (32 patients)
CHEST DISCOMFORT (32 patients)
MOOD SWINGS (31 patients)
FEELING HOT (30 patients)
RENAL FAILURE ACUTE (29 patients)
ANAL HAEMORRHAGE (29 patients)
URINARY TRACT INFECTION (29 patients)
PARAESTHESIA (29 patients)
BLOOD COUNT ABNORMAL (29 patients)
ASCITES (28 patients)
TRANSFUSION (28 patients)
PALPITATIONS (27 patients)
ANORECTAL DISORDER (27 patients)
HAEMATOCRIT DECREASED (27 patients)
FALL (26 patients)
PHOTOPHOBIA (26 patients)
CELLULITIS (26 patients)
CONVULSION (25 patients)
AMMONIA INCREASED (25 patients)
APHAGIA (25 patients)
MOUTH ULCERATION (24 patients)
LETHARGY (24 patients)
NASOPHARYNGITIS (23 patients)
FEELING COLD (23 patients)
JOINT SWELLING (23 patients)
OEDEMA (23 patients)
GINGIVAL BLEEDING (23 patients)
HOSPITALISATION (22 patients)
THROMBOSIS (22 patients)
FACE OEDEMA (22 patients)
ORAL CANDIDIASIS (22 patients)
RASH MACULAR (22 patients)
RASH MACULO-PAPULAR (22 patients)
CRYING (22 patients)
SWOLLEN TONGUE (21 patients)
INJECTION SITE ERYTHEMA (21 patients)
GASTROOESOPHAGEAL REFLUX DISEASE (21 patients)
DISTURBANCE IN ATTENTION (21 patients)
VERTIGO (21 patients)
RENAL IMPAIRMENT (21 patients)
EYE PAIN (21 patients)
DRUG ADMINISTRATION ERROR (20 patients)
MEDICATION ERROR (20 patients)
RASH VESICULAR (20 patients)
BONE PAIN (20 patients)
EYE SWELLING (20 patients)
RETCHING (20 patients)
HYPERSOMNIA (20 patients)
LYMPHADENOPATHY (19 patients)
VISUAL IMPAIRMENT (19 patients)
ANGER (19 patients)
SKIN BURNING SENSATION (19 patients)
SINUSITIS (19 patients)
SLEEP DISORDER (18 patients)
MYOCARDIAL INFARCTION (18 patients)
BLOOD BILIRUBIN INCREASED (18 patients)
DRY EYE (18 patients)
DYSURIA (18 patients)
SWELLING (18 patients)
HYPERSENSITIVITY (18 patients)
HAEMATEMESIS (17 patients)
FREQUENT BOWEL MOVEMENTS (17 patients)
PULMONARY EMBOLISM (17 patients)
INFECTION (17 patients)
DRUG ERUPTION (17 patients)
PAINFUL DEFAECATION (17 patients)
BLOOD URIC ACID INCREASED (17 patients)
POLLAKIURIA (17 patients)
ORAL PAIN (16 patients)
JAUNDICE (16 patients)
FLATULENCE (16 patients)
ENCEPHALOPATHY (16 patients)
BALANCE DISORDER (16 patients)
DISORIENTATION (16 patients)
BLOOD GLUCOSE DECREASED (16 patients)
HAEMORRHAGE (16 patients)
BLOOD PRESSURE DECREASED (16 patients)
BLOOD SODIUM DECREASED (16 patients)
BURNING SENSATION (16 patients)
HEPATIC FAILURE (16 patients)
LIP SWELLING (16 patients)
AGITATION (15 patients)
CONTUSION (15 patients)
MUSCULAR WEAKNESS (15 patients)
FAECES DISCOLOURED (15 patients)
FLUID RETENTION (15 patients)
BRONCHITIS (15 patients)
NEUTROPHIL COUNT DECREASED (15 patients)
PALLOR (14 patients)
ACCIDENTAL OVERDOSE (14 patients)
TACHYCARDIA (14 patients)
AMNESIA (14 patients)
LEUKOPENIA (14 patients)
HALLUCINATION (14 patients)
DYSPNOEA EXERTIONAL (14 patients)
PANIC ATTACK (14 patients)
BODY TEMPERATURE INCREASED (14 patients)
EATING DISORDER (14 patients)
EMOTIONAL DISORDER (14 patients)
ACUTE RESPIRATORY DISTRESS SYNDROME (13 patients)
PRODUCTIVE COUGH (13 patients)
OROPHARYNGEAL BLISTERING (13 patients)
NO THERAPEUTIC RESPONSE (13 patients)
RENAL DISORDER (13 patients)
CEREBROVASCULAR ACCIDENT (13 patients)

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Recent FactMed Activity for INCIVEK


Issue Description / Topic Timestamp
QUESTION
COLON OPERATION
i was taking incivek along with interferon and ribavirin and started getting edema and skin lesions. on the heels of this, I developed a ruptured colon that my gastroenterologist assured me was not related to the drug regimen. But I feel that if lesions were caused externally, it is also possible that they incurred internally as well, in my colon perhaps. 2017-02-04 11:50:57

My Patient Resources

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Your Question:

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Your Experience or Concern:

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