The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
125808262 12580826 2 F 20151115 20160720 20160721 20160729 EXP US-JNJFOC-20160714950 JANSSEN 47.23 YR A F Y 71.70000 KG 20160729 MD US US

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
125808262 12580826 1 PS XARELTO RIVAROXABAN 1 Oral U U 22406 10 MG TABLET QD
125808262 12580826 2 SS BAYER ASPIRIN ASPIRIN 1 Unknown U 0 UNSPECIFIED
125808262 12580826 3 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 10 MG UNSPECIFIED TID
125808262 12580826 4 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 2.5 MG UNSPECIFIED
125808262 12580826 5 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 5 MG UNSPECIFIED TID
125808262 12580826 6 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 7.5 MG UNSPECIFIED Q8H
125808262 12580826 7 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 7.5 MG UNSPECIFIED TID
125808262 12580826 8 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 2.5 MG UNSPECIFIED TID
125808262 12580826 9 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 5 MG UNSPECIFIED BID
125808262 12580826 10 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 UNSPECIFIED
125808262 12580826 11 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 2.5 MG UNSPECIFIED Q8H
125808262 12580826 12 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 UNSPECIFIED
125808262 12580826 13 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 17.5 MG UNSPECIFIED QD
125808262 12580826 14 SS ORENITRAM TREPROSTINIL 1 Oral U 2100399;1500226A;1500227A 0 17.5 MG UNSPECIFIED QD
125808262 12580826 15 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 16 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED
125808262 12580826 17 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 18 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 19 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 20 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 21 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED
125808262 12580826 22 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 23 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 24 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 25 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 26 SS LETAIRIS AMBRISENTAN 1 Oral U SBFW;1500226A;1500225A;1500227A 0 10 MG UNSPECIFIED QD
125808262 12580826 27 SS REVATIO SILDENAFIL CITRATE 1 Oral U 0 60 MG UNSPECIFIED TID
125808262 12580826 28 SS METOLAZONE. METOLAZONE 1 Oral U 0 5 MG UNSPECIFIED QD
125808262 12580826 29 SS REMODULIN TREPROSTINIL 1 Intravenous drip U 926118 0 .092 IU/KG UNSPECIFIED
125808262 12580826 30 C PROMETHAZINE PROMETHAZINEPROMETHAZINE HYDROCHLORIDE 1 Unknown 0 UNSPECIFIED
125808262 12580826 31 C SIMVASTATIN. SIMVASTATIN 1 Oral 0 10 MG UNSPECIFIED QD
125808262 12580826 32 C SIMVASTATIN. SIMVASTATIN 1 Oral 0 5 MG UNSPECIFIED QD
125808262 12580826 33 C BIOTIN BIOTIN 1 Oral 0 5000 UG UNSPECIFIED QD
125808262 12580826 34 C CELEBREX CELECOXIB 1 Oral 0 100 MG UNSPECIFIED QD
125808262 12580826 35 C DIGOXIN. DIGOXIN 1 Oral 0 .125 UG UNSPECIFIED QD
125808262 12580826 36 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Oral 0 25 MG UNSPECIFIED BID
125808262 12580826 37 C FLUTICASONE FLUTICASONEFLUTICASONE PROPIONATE 1 Topical 0 UNSPECIFIED
125808262 12580826 38 C KLOR-CON POTASSIUM CHLORIDE 1 Unknown 0 20 MEQ UNSPECIFIED TID
125808262 12580826 39 C MELOXICAM. MELOXICAM 1 Oral 0 7.5 MG UNSPECIFIED QD
125808262 12580826 40 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 Oral 0 40 MG UNSPECIFIED BID
125808262 12580826 41 C ONDANSETRON ONDANSETRON 1 Oral 0 40 MG UNSPECIFIED QID
125808262 12580826 42 C OXYGEN. OXYGEN 1 Nasal 0 2.5 L UNSPECIFIED
125808262 12580826 43 C REQUIP ROPINIROLE HYDROCHLORIDE 1 Oral 0 .75 MG UNSPECIFIED QD
125808262 12580826 44 C ALDACTONE SPIRONOLACTONE 1 Unknown 0 100 MG UNSPECIFIED QD
125808262 12580826 45 C COLACE DOCUSATE SODIUM 1 Oral 0 250 MG UNSPECIFIED BID
125808262 12580826 46 C ASCORBIC ACID. ASCORBIC ACID 1 Oral 0 500 MG UNSPECIFIED QD
125808262 12580826 47 C IRON IRON 1 Oral 0 225 MG UNSPECIFIED BID
125808262 12580826 48 C RANITIDINE. RANITIDINE 1 Unknown 0 300 MG UNSPECIFIED BID
125808262 12580826 49 C ACIPHEX RABEPRAZOLE SODIUM 1 Unknown 0 UNSPECIFIED
125808262 12580826 50 C ATIVAN LORAZEPAM 1 Unknown 0 UNSPECIFIED
125808262 12580826 51 C SINEMET CARBIDOPALEVODOPA 1 Unknown 0 UNSPECIFIED
125808262 12580826 52 C INVANZ ERTAPENEM SODIUM 1 Intravenous (not otherwise specified) 0 1 G UNSPECIFIED QD
125808262 12580826 53 C TORSEMIDE. TORSEMIDE 1 Unknown 0 UNSPECIFIED
125808262 12580826 54 C SYNTHROID LEVOTHYROXINE SODIUM 1 Oral 0 100 UG UNSPECIFIED QD
125808262 12580826 55 C ELAVIL AMITRIPTYLINE HYDROCHLORIDE 1 Unknown 0 UNSPECIFIED
125808262 12580826 56 C DEMADEX TORSEMIDE 1 Unknown 0 20 MG UNSPECIFIED TID
125808262 12580826 57 C CALCIUM CALCIUM 1 Unknown 0 UNSPECIFIED
125808262 12580826 58 C ALPRAZOLAM. ALPRAZOLAM 1 Unknown 0 UNSPECIFIED
125808262 12580826 59 C CYANOCOBALAMINE CYANOCOBALAMIN 1 Unknown 0 UNSPECIFIED
125808262 12580826 60 C MORPHINE HYDROCHLORIDE MORPHINE HYDROCHLORIDE 1 Unknown 0 UNSPECIFIED
125808262 12580826 61 C VITAMIN B COMPLEX CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX 1 Unknown 0 UNSPECIFIED
125808262 12580826 62 C FERROUS GLUCONATE FERROUS GLUCONATE 1 Unknown 0 225 MG UNSPECIFIED BID
125808262 12580826 63 C TRAMADOL. TRAMADOL 1 Unknown 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125808262 12580826 1 Product used for unknown indication
125808262 12580826 2 Product used for unknown indication
125808262 12580826 3 Pulmonary hypertension
125808262 12580826 4 Pulmonary hypertension
125808262 12580826 5 Pulmonary hypertension
125808262 12580826 6 Pulmonary hypertension
125808262 12580826 7 Pulmonary hypertension
125808262 12580826 8 Pulmonary hypertension
125808262 12580826 9 Pulmonary hypertension
125808262 12580826 10 Pulmonary hypertension
125808262 12580826 11 Pulmonary hypertension
125808262 12580826 12 Pulmonary hypertension
125808262 12580826 13 Pulmonary hypertension
125808262 12580826 14 Pulmonary hypertension
125808262 12580826 15 Drug abuse
125808262 12580826 16 Drug abuse
125808262 12580826 17 Drug abuse
125808262 12580826 18 Drug abuse
125808262 12580826 19 Drug abuse
125808262 12580826 20 Drug abuse
125808262 12580826 21 Pulmonary hypertension
125808262 12580826 22 Pulmonary hypertension
125808262 12580826 23 Pulmonary hypertension
125808262 12580826 24 Pulmonary hypertension
125808262 12580826 25 Pulmonary hypertension
125808262 12580826 26 Pulmonary hypertension
125808262 12580826 27 Product used for unknown indication
125808262 12580826 28 Oedema
125808262 12580826 29 Pulmonary hypertension

Outcome of event

Event ID CASEID OUTC COD
125808262 12580826 HO
125808262 12580826 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125808262 12580826 Acute myocardial infarction
125808262 12580826 Acute respiratory failure
125808262 12580826 Adverse drug reaction
125808262 12580826 Ascites
125808262 12580826 Asthenia
125808262 12580826 Bladder disorder
125808262 12580826 Blood pressure decreased
125808262 12580826 Cardiac failure acute
125808262 12580826 Cellulitis
125808262 12580826 Chest discomfort
125808262 12580826 Chills
125808262 12580826 Clostridium difficile infection
125808262 12580826 Device occlusion
125808262 12580826 Device related sepsis
125808262 12580826 Dizziness
125808262 12580826 Drug dose omission
125808262 12580826 Drug intolerance
125808262 12580826 Dyspnoea
125808262 12580826 Ear haemorrhage
125808262 12580826 Fatigue
125808262 12580826 Fluid overload
125808262 12580826 Fluid retention
125808262 12580826 Flushing
125808262 12580826 Gait disturbance
125808262 12580826 Gastric ulcer
125808262 12580826 Headache
125808262 12580826 Hypotension
125808262 12580826 Influenza like illness
125808262 12580826 Injection site pain
125808262 12580826 Localised oedema
125808262 12580826 Malaise
125808262 12580826 Muscle spasms
125808262 12580826 Nausea
125808262 12580826 Oedema peripheral
125808262 12580826 Otorrhoea
125808262 12580826 Pain
125808262 12580826 Pain in jaw
125808262 12580826 Palpitations
125808262 12580826 Pericardial effusion
125808262 12580826 Pleural effusion
125808262 12580826 Productive cough
125808262 12580826 Pyrexia
125808262 12580826 Staphylococcal bacteraemia
125808262 12580826 Syncope
125808262 12580826 Upper respiratory tract infection
125808262 12580826 Urinary incontinence
125808262 12580826 Vomiting

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
125808262 12580826 5 20160307 0
125808262 12580826 11 20151229 20160309 0
125808262 12580826 12 20160307 0
125808262 12580826 15 20110208 0
125808262 12580826 16 20130404 0
125808262 12580826 21 20130404 0
125808262 12580826 25 20110208 0
125808262 12580826 27 201501 0
125808262 12580826 29 20140608 201602 0