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
1193866718 11938667 18 F 201601 20160621 20160122 20160705 EXP US-UNITED THERAPEUTICS-UNT-2016-000811 UNITED THERAPEUTICS 47.35 YR F Y 71.65000 KG 20160705 OT 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
1193866718 11938667 1 PS ORENITRAM TREPROSTINIL 1 Oral 2.5 MG, Q8H 150 MG Y 2100399 203496 2.5 MG TABLET TID
1193866718 11938667 2 SS ORENITRAM TREPROSTINIL 1 Oral 10 MG, TID 150 MG Y 2100399 203496 10 MG TABLET TID
1193866718 11938667 3 SS ORENITRAM TREPROSTINIL 1 Oral 2.5 MG, TID 150 MG Y 203496 2.5 MG TABLET TID
1193866718 11938667 4 SS ORENITRAM TREPROSTINIL 1 Oral 2.5 MG, UD 150 MG Y 2100399 203496 2.5 MG TABLET
1193866718 11938667 5 SS ORENITRAM TREPROSTINIL 1 Oral 7.5 MG, TID 150 MG Y 2100399 203496 7.5 MG TABLET TID
1193866718 11938667 6 SS ORENITRAM TREPROSTINIL 1 Oral 5MG, BID 150 MG Y 2100399 203496 5 MG TABLET BID
1193866718 11938667 7 SS ORENITRAM TREPROSTINIL 1 Oral 17.5 MG, TOTAL DAILY DOSE 150 MG Y 2100399 203496 TABLET
1193866718 11938667 8 SS ORENITRAM TREPROSTINIL 1 Oral 7.5 MG, Q8H 150 MG Y 2100679 203496 7.5 MG TABLET TID
1193866718 11938667 9 SS ORENITRAM TREPROSTINIL 1 Oral 5 MG, TID 150 MG Y 203496 5 MG TABLET TID
1193866718 11938667 10 SS ORENITRAM TREPROSTINIL 1 2.5 MG, UNK 150 MG Y 203496 2.5 MG TABLET
1193866718 11938667 11 SS ORENITRAM TREPROSTINIL 1 Oral 17.5 MG, QD 150 MG Y 203496 17.5 MG TABLET QD
1193866718 11938667 12 SS LETAIRIS AMBRISENTAN 1 Oral 10 MG, QD 1500226A 0 10 MG TABLET QD
1193866718 11938667 13 SS LETAIRIS AMBRISENTAN 1 Unknown 10 UNK, UNK 1500225A 0 10 MG TABLET QD
1193866718 11938667 14 SS LETAIRIS AMBRISENTAN 1 Unknown UNK 1500227A 0 TABLET
1193866718 11938667 15 SS LETAIRIS AMBRISENTAN 1 UNK 1504764 0 TABLET
1193866718 11938667 16 SS LETAIRIS AMBRISENTAN 1 UNK 0 TABLET
1193866718 11938667 17 SS LETAIRIS AMBRISENTAN 1 UNK 0 TABLET
1193866718 11938667 18 SS REVATIO SILDENAFIL CITRATE 1 Oral 60 MG, TID 0 60 MG TID
1193866718 11938667 19 SS ACETYLSALICYLIC ACID ASPIRIN 1 U U 0
1193866718 11938667 20 C DEMADEX TORSEMIDE 1 Oral 20 MG, TID 0
1193866718 11938667 21 C CALCIUM CALCIUM 1 0
1193866718 11938667 22 C SYNTHROID LEVOTHYROXINE SODIUM 1 Oral 100 MCG, QD 0
1193866718 11938667 23 C MORPHINE HYDROCHLORIDE MORPHINE HYDROCHLORIDE 1 2 MG, UNK 0 2 MG
1193866718 11938667 24 C PROMETHAZINE PROMETHAZINEPROMETHAZINE HYDROCHLORIDE 1 25 MG, UNK 0 25 MG
1193866718 11938667 25 C VITAMIN B COMPLEX CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX 1 0
1193866718 11938667 26 C VITAMIN B12 CYANOCOBALAMIN 1 0
1193866718 11938667 27 C TRAMADOL. TRAMADOL 1 0
1193866718 11938667 28 C ALPRAZOLAM. ALPRAZOLAM 1 0
1193866718 11938667 29 C ELAVIL AMITRIPTYLINE HYDROCHLORIDE 1 10 MG, TAKE 2 MORNING AND 3 AT NIGHT 0
1193866718 11938667 30 C BIOTIN BIOTIN 1 2500 MCG, TAKE 2 BY ORAL ROUTE EVERY DAY 0
1193866718 11938667 31 C CELEBREX CELECOXIB 1 Oral 100 MG, TAKE ONE TABLET EVERYDAY 0
1193866718 11938667 32 C DIGOXIN. DIGOXIN 1 Oral 125 MCG, QD 0
1193866718 11938667 33 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Oral 25 MG, TAKE ONE TABLET TWO TIMES EVERY BEDTIME AS NEEDED 0
1193866718 11938667 34 C FERROUS GLUCONATE FERROUS GLUCONATE 1 Topical APPLY TWO TIMES EVERY DAY A THIN LAYER TO THE AFFECTED AREAS 0
1193866718 11938667 35 C FLUTICASONE FLUTICASONEFLUTICASONE PROPIONATE 1 0
1193866718 11938667 36 C KLOR-CON POTASSIUM CHLORIDE 1 20 MEQ, TID 0 20 MEQ TID
1193866718 11938667 37 C MELOXICAM. MELOXICAM 1 Oral 7.5 MG, QD 0
1193866718 11938667 38 C METOLAZONE. METOLAZONE 1 Oral 5 MG, TAKE ONE TABLET DAILY AS NEEDED 0
1193866718 11938667 39 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 Oral 40 MG, TAKE ONE CAPSUE TWICE DAILY BEFORE A MEAL 0
1193866718 11938667 40 C ONDANSETRAN ONDANSETRON HYDROCHLORIDE 1 Oral 4 MG, ONCE EVERY 6 HOURS 0
1193866718 11938667 41 C OXYGEN. OXYGEN 1 Nasal INHALE 2.5 LITERS BY NASAL ROUTE ONCE 0
1193866718 11938667 42 C REQUIP ROPINIROLE HYDROCHLORIDE 1 0.75 MG EVERY EVENING 0
1193866718 11938667 43 C SIMVASTATIN. SIMVASTATIN 1 Oral 10 MG, TAKE ONE TABLET BY EVERY EVENING 0
1193866718 11938667 44 C ALDACTONE SPIRONOLACTONE 1 Oral 50 MG, TAKE TWO TABLETS ONCE DAILY AS DIRECTED 0
1193866718 11938667 45 C COLACE DOCUSATE SODIUM 1 Oral 250 MG, TAKE ONCE CAPSULE TWICE DAILY AS NEEDED 0
1193866718 11938667 46 C XARELTO RIVAROXABAN 1 10 MG, QD 0 10 MG QD
1193866718 11938667 47 C ASCORBIC ACID. ASCORBIC ACID 1 Oral 500 MG, QD 0
1193866718 11938667 48 C IRON IRON 1 225 MG, BID 0 225 MG BID
1193866718 11938667 49 C VITAMIN C ASCORBIC ACID 1 0
1193866718 11938667 50 C RANITIDINE. RANITIDINE 1 300 MG, BID 0 300 MG BID
1193866718 11938667 51 C TORSEMIDE. TORSEMIDE 1 0
1193866718 11938667 52 C ACIPHEX RABEPRAZOLE SODIUM 1 0
1193866718 11938667 53 C ATIVAN LORAZEPAM 1 0
1193866718 11938667 54 C SINEMET CARBIDOPALEVODOPA 1 0
1193866718 11938667 55 C INVANZ ERTAPENEM SODIUM 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1193866718 11938667 1 Pulmonary hypertension
1193866718 11938667 12 Pulmonary hypertension
1193866718 11938667 13 Drug abuse
1193866718 11938667 18 Product used for unknown indication
1193866718 11938667 19 Product used for unknown indication
1193866718 11938667 20 Product used for unknown indication
1193866718 11938667 21 Product used for unknown indication
1193866718 11938667 22 Product used for unknown indication
1193866718 11938667 23 Product used for unknown indication
1193866718 11938667 24 Product used for unknown indication
1193866718 11938667 25 Product used for unknown indication
1193866718 11938667 26 Product used for unknown indication
1193866718 11938667 27 Product used for unknown indication
1193866718 11938667 28 Product used for unknown indication
1193866718 11938667 29 Product used for unknown indication
1193866718 11938667 30 Product used for unknown indication
1193866718 11938667 31 Product used for unknown indication
1193866718 11938667 32 Product used for unknown indication
1193866718 11938667 33 Product used for unknown indication
1193866718 11938667 34 Product used for unknown indication
1193866718 11938667 35 Product used for unknown indication
1193866718 11938667 36 Product used for unknown indication
1193866718 11938667 37 Product used for unknown indication
1193866718 11938667 38 Oedema
1193866718 11938667 39 Product used for unknown indication
1193866718 11938667 40 Product used for unknown indication
1193866718 11938667 41 Product used for unknown indication
1193866718 11938667 42 Product used for unknown indication
1193866718 11938667 43 Product used for unknown indication
1193866718 11938667 44 Product used for unknown indication
1193866718 11938667 45 Product used for unknown indication
1193866718 11938667 46 Product used for unknown indication
1193866718 11938667 47 Product used for unknown indication
1193866718 11938667 48 Product used for unknown indication
1193866718 11938667 49 Product used for unknown indication
1193866718 11938667 50 Product used for unknown indication
1193866718 11938667 51 Product used for unknown indication
1193866718 11938667 52 Product used for unknown indication
1193866718 11938667 53 Product used for unknown indication
1193866718 11938667 54 Product used for unknown indication
1193866718 11938667 55 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
1193866718 11938667 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
1193866718 11938667 Abdominal discomfort
1193866718 11938667 Ascites
1193866718 11938667 Bladder disorder
1193866718 11938667 Clostridium difficile infection
1193866718 11938667 Diarrhoea
1193866718 11938667 Dizziness
1193866718 11938667 Drug administration error
1193866718 11938667 Drug interaction
1193866718 11938667 Drug intolerance
1193866718 11938667 Dyspnoea
1193866718 11938667 Dyspnoea exertional
1193866718 11938667 Fatigue
1193866718 11938667 Fluid retention
1193866718 11938667 Flushing
1193866718 11938667 Gastric ulcer
1193866718 11938667 Headache
1193866718 11938667 Hypotension
1193866718 11938667 Influenza like illness
1193866718 11938667 Localised oedema
1193866718 11938667 Malaise
1193866718 11938667 Muscle spasms
1193866718 11938667 Nausea
1193866718 11938667 Oedema peripheral
1193866718 11938667 Otorrhoea
1193866718 11938667 Pain
1193866718 11938667 Pain in jaw
1193866718 11938667 Palpitations
1193866718 11938667 Pleural effusion
1193866718 11938667 Post procedural haemorrhage
1193866718 11938667 Syncope
1193866718 11938667 Urinary incontinence
1193866718 11938667 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
1193866718 11938667 1 20151229 20160309 0
1193866718 11938667 9 20160307 0
1193866718 11938667 12 20110208 0
1193866718 11938667 13 20130404 0
1193866718 11938667 18 201501 0