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
123427925 12342792 5 F 20151115 20160720 20160506 20160727 EXP US-BAYER-2016-081833 BAYER 47.00 YR A F Y 71.70000 KG 20160727 CN 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
123427925 12342792 1 PS BAYER GENUINE ASPIRIN ASPIRIN 1 999999 FILM-COATED TABLET
123427925 12342792 2 SS ORENITRAM TREPROSTINIL 1 Oral 2.5 MG, Q8HR 2100399 0 2.5 MG Q8H
123427925 12342792 3 SS ORENITRAM TREPROSTINIL 1 Oral 10 MG, TID 2100399 0 10 MG TID
123427925 12342792 4 SS ORENITRAM TREPROSTINIL 1 Oral 2.5 MG, TID 0 2.5 MG TID
123427925 12342792 5 SS ORENITRAM TREPROSTINIL 1 Oral 2.5 MG, UNK 2100399 0 2.5 MG
123427925 12342792 6 SS ORENITRAM TREPROSTINIL 1 Oral 7.5 MG, TID 2100399 0 7.5 MG TID
123427925 12342792 7 SS ORENITRAM TREPROSTINIL 1 Oral 5 MG, BID 2100399 0 5 MG BID
123427925 12342792 8 SS ORENITRAM TREPROSTINIL 1 Oral 17.5 MG, QD 2100399 0 17.5 MG QD
123427925 12342792 9 SS ORENITRAM TREPROSTINIL 1 Oral 7.5 MG, Q8HR 2100679 0 7.5 MG Q8H
123427925 12342792 10 SS ORENITRAM TREPROSTINIL 1 Oral 5 MG, TID 0 5 MG TID
123427925 12342792 11 SS ORENITRAM TREPROSTINIL 1 Oral UNK UNK, TID 1500226A 0
123427925 12342792 12 SS ORENITRAM TREPROSTINIL 1 Oral UNK UNK, TID 1500227A 0
123427925 12342792 13 SS ORENITRAM TREPROSTINIL 1 17.5 UNK, UNK 0 17.5 MG QD
123427925 12342792 14 SS REMODULIN TREPROSTINIL 1 Intravenous drip 0.092 ?G/KG, CONTINIOUS IV DRIP 926118 0 .092 UG/KG
123427925 12342792 15 SS LETAIRIS AMBRISENTAN 1 Oral 10 MG, QD 0 10 MG QD
123427925 12342792 16 SS LETAIRIS AMBRISENTAN 1 10 MG, UNK SBFW 0 10 MG
123427925 12342792 17 SS LETAIRIS AMBRISENTAN 1 10 MG, QD 1500226A 0 10 MG QD
123427925 12342792 18 SS LETAIRIS AMBRISENTAN 1 10 MG, QD 1500225A 0 10 MG QD
123427925 12342792 19 SS LETAIRIS AMBRISENTAN 1 10 MG, QD 1500227A 0 10 MG QD
123427925 12342792 20 SS LETAIRIS AMBRISENTAN 1 Oral 10 MG, QD AM 0 10 MG QD
123427925 12342792 21 SS REVATIO SILDENAFIL CITRATE 1 Oral 60 MG, TID 0 60 MG TID
123427925 12342792 22 SS XARELTO RIVAROXABAN 1 Oral 10 MG, QD 0 10 MG FILM-COATED TABLET QD
123427925 12342792 23 C MORPHINE HYDROCHLORIDE MORPHINE HYDROCHLORIDE 1 UNK 0
123427925 12342792 24 C PROMETHAZINE PROMETHAZINEPROMETHAZINE HYDROCHLORIDE 1 UNK 0
123427925 12342792 25 C VITAMIN B COMPLEX CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX 1 UNK 0
123427925 12342792 26 C VITAMIN B12 CYANOCOBALAMIN 1 UNK 0
123427925 12342792 27 C TRAMADOL. TRAMADOL 1 UNK 0
123427925 12342792 28 C ALPRAZOLAM. ALPRAZOLAM 1 UNK 0
123427925 12342792 29 C CALCIUM CALCIUM 1 0
123427925 12342792 30 C DEMADEX TORSEMIDE 1 20 MG, TID (60MG PER DAY) 0 20 MG TID
123427925 12342792 31 C ELAVIL AMITRIPTYLINE HYDROCHLORIDE 1 10MG, 3 TABLETS AT NIGHT 0
123427925 12342792 32 C SYNTHROID LEVOTHYROXINE SODIUM 1 Oral 100 ?G, QD 0 100 UG QD
123427925 12342792 33 C BIOTIN BIOTIN 1 Oral 5000 ?G, QD 0 5000 UG QD
123427925 12342792 34 C CELEBREX CELECOXIB 1 Oral 100 MG, QD 0 100 MG QD
123427925 12342792 35 C DIGOXIN. DIGOXIN 1 Oral 0.125 ?G, QD 0 .125 UG QD
123427925 12342792 36 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Oral 25 MG, BID EVERY BEDTIME AS NEEDED 0 25 MG BID
123427925 12342792 37 C FERROUS GLUCONATE FERROUS GLUCONATE 1 Oral 225 MG, BID 0 225 MG BID
123427925 12342792 38 C FLUTICASONE FLUTICASONEFLUTICASONE PROPIONATE 1 Topical UNK, BID 0 BID
123427925 12342792 39 C KLOR-CON POTASSIUM CHLORIDE 1 20 MEQ, TID 0 20 MEQ TID
123427925 12342792 40 C MELOXICAM. MELOXICAM 1 Oral 7.5 MG, QD 0 7.5 MG QD
123427925 12342792 41 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 Oral 40 MG, BID BEFORE MEAL 0 40 MG BID
123427925 12342792 42 C ONDANSETRON ONDANSETRON 1 Oral 40 MG, QID EVERY 6 HOURS 0 40 MG QID
123427925 12342792 43 C OXYGEN. OXYGEN 1 Nasal INHALE 2.5 L, UNK 0 2.5 L
123427925 12342792 44 C REQUIP ROPINIROLE HYDROCHLORIDE 1 Oral 0.75 MG, QD EVERY EVENING 0 .75 MG QD
123427925 12342792 45 C SIMVASTATIN. SIMVASTATIN 1 Oral 10 MG, QD EVERY EVENING 0 10 MG QD
123427925 12342792 46 C SIMVASTATIN. SIMVASTATIN 1 Oral 5 MG, QD 0 5 MG QD
123427925 12342792 47 C ALDACTONE SPIRONOLACTONE 1 100 MG, QD AM 0 100 MG QD
123427925 12342792 48 C COLACE DOCUSATE SODIUM 1 Oral 250 MG, BID AS NEEDED 0 250 MG BID
123427925 12342792 49 C ASCORBIC ACID. ASCORBIC ACID 1 Oral 500 MG, QD 0 500 MG QD
123427925 12342792 50 C IRON IRON 1 Oral 225 MG, BID 0 225 MG BID
123427925 12342792 51 C RANITIDINE. RANITIDINE 1 300 MG, BID 0 300 MG BID
123427925 12342792 52 C ACIPHEX RABEPRAZOLE SODIUM 1 UNK 0
123427925 12342792 53 C ATIVAN LORAZEPAM 1 UNK 0
123427925 12342792 54 C SINEMET CARBIDOPALEVODOPA 1 UNK 0
123427925 12342792 55 C INVANZ ERTAPENEM SODIUM 1 Intravenous (not otherwise specified) 1 G, QD 0 1 G QD
123427925 12342792 56 C UPTRAVI SELEXIPAG 1 200 MG, QD 0 200 MG QD
123427925 12342792 57 C TORSEMIDE. TORSEMIDE 1 0
123427925 12342792 58 SS METOLAZONE. METOLAZONE 1 Oral 5 MG, QD 0 5 MG QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
123427925 12342792 1 Product used for unknown indication
123427925 12342792 2 Pulmonary hypertension
123427925 12342792 3 Pulmonary hypertension
123427925 12342792 4 Pulmonary hypertension
123427925 12342792 5 Pulmonary hypertension
123427925 12342792 6 Pulmonary hypertension
123427925 12342792 7 Pulmonary hypertension
123427925 12342792 8 Pulmonary hypertension
123427925 12342792 9 Pulmonary hypertension
123427925 12342792 10 Pulmonary hypertension
123427925 12342792 11 Pulmonary hypertension
123427925 12342792 12 Pulmonary hypertension
123427925 12342792 13 Pulmonary hypertension
123427925 12342792 14 Pulmonary hypertension
123427925 12342792 15 Pulmonary hypertension
123427925 12342792 16 Drug abuse
123427925 12342792 17 Pulmonary hypertension
123427925 12342792 18 Pulmonary hypertension
123427925 12342792 19 Pulmonary hypertension
123427925 12342792 20 Pulmonary hypertension
123427925 12342792 21 Product used for unknown indication
123427925 12342792 58 Oedema

Outcome of event

Event ID CASEID OUTC COD
123427925 12342792 OT
123427925 12342792 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
123427925 12342792 Abdominal discomfort
123427925 12342792 Abdominal pain
123427925 12342792 Acute myocardial infarction
123427925 12342792 Acute respiratory failure
123427925 12342792 Adverse drug reaction
123427925 12342792 Ascites
123427925 12342792 Asthenia
123427925 12342792 Bladder disorder
123427925 12342792 Blood pressure decreased
123427925 12342792 Cardiac failure acute
123427925 12342792 Cellulitis
123427925 12342792 Chest discomfort
123427925 12342792 Chills
123427925 12342792 Clostridium difficile infection
123427925 12342792 Device occlusion
123427925 12342792 Device related sepsis
123427925 12342792 Diarrhoea
123427925 12342792 Dizziness
123427925 12342792 Drug dose omission
123427925 12342792 Drug intolerance
123427925 12342792 Dyspnoea
123427925 12342792 Ear haemorrhage
123427925 12342792 Fatigue
123427925 12342792 Fluid overload
123427925 12342792 Fluid retention
123427925 12342792 Flushing
123427925 12342792 Gait disturbance
123427925 12342792 Gastric ulcer
123427925 12342792 Headache
123427925 12342792 Hypotension
123427925 12342792 Influenza like illness
123427925 12342792 Injection site pain
123427925 12342792 Localised oedema
123427925 12342792 Malaise
123427925 12342792 Muscle spasms
123427925 12342792 Nausea
123427925 12342792 Oedema peripheral
123427925 12342792 Otorrhoea
123427925 12342792 Pain
123427925 12342792 Pain in jaw
123427925 12342792 Palpitations
123427925 12342792 Pericardial effusion
123427925 12342792 Pleural effusion
123427925 12342792 Productive cough
123427925 12342792 Pyrexia
123427925 12342792 Staphylococcal bacteraemia
123427925 12342792 Syncope
123427925 12342792 Upper respiratory tract infection
123427925 12342792 Urinary incontinence
123427925 12342792 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
123427925 12342792 2 20151229 20160309 0
123427925 12342792 10 20160307 0
123427925 12342792 12 20160307 0
123427925 12342792 14 20140608 201602 0
123427925 12342792 15 20110208 0
123427925 12342792 16 20130404 0
123427925 12342792 21 201501 0