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
115339516 11533951 6 F 2015 20160825 20150922 20160907 EXP ES-AMGEN-ESPSP2015079117 AMGEN 67.00 YR E F Y 0.00000 20160906 CN ES ES

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
115339516 11533951 1 PS ENBREL ETANERCEPT 1 Subcutaneous 50 MG, WEEKLY L76727 103795 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE /wk
115339516 11533951 2 I ENBREL ETANERCEPT 1 Subcutaneous 50 MG, WEEKLY M01666 103795 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE /wk
115339516 11533951 3 I ENBREL ETANERCEPT 1 Subcutaneous 50 MG, WEEKLY M32509 103795 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE /wk
115339516 11533951 4 I ENBREL ETANERCEPT 1 Subcutaneous 50 MG, WEEKLY N69734 103795 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE /wk
115339516 11533951 5 I ENBREL ETANERCEPT 1 Unknown 50 MG, WEEKLY N19328 103795 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE /wk
115339516 11533951 6 I METHOTREXATE SODIUM. METHOTREXATE SODIUM 1 Oral 7.5 MG, WEEKLY (1 TABLET AT 2.5 MG EVERY 8 HOURS EVERY WEDNESDAY) 0 7.5 MG /wk
115339516 11533951 7 C EUTIROX LEVOTHYROXINE SODIUM 1 100 MUG, 1X/DAY (1 TABLET EVERY 24 HOURS) 0 TABLET QD
115339516 11533951 8 C EUTIROX LEVOTHYROXINE SODIUM 1 100 UG, 1X/DAY (1 TABLET EVERY 24 HOURS) 0 100 UG TABLET
115339516 11533951 9 C VALSARTAN. VALSARTAN 1 1 DF, 1X/DAY (1 TABLET EVERY 24 HOURS) 0 160 MG TABLET QD
115339516 11533951 10 C VALSARTAN. VALSARTAN 1 1 DF, 1X/DAY (1 TABLET EVERY 24 HOURS) 0 160 MG TABLET QD
115339516 11533951 11 C PANKREOFLAT 2 1 DF, 3X/DAY (1 TABLET EVERY 8 HOURS) 0 1 DF TABLET TID
115339516 11533951 12 C PAROXETINE. PAROXETINE 1 20 MG, 1X/DAY (1 TABLET AT MIDDAY ) 0 20 MG TABLET QD
115339516 11533951 13 C PAROXETINE. PAROXETINE 1 20 MG, 1X/DAY (1 TABLET AT MIDDAY ) 0 20 MG TABLET QD
115339516 11533951 14 C ROCALTROL CALCITRIOL 1 2 DF, 1X/DAY (2 TABLETS OF 0.25 AT MIDDAY) 0 2 DF TABLET QD
115339516 11533951 15 C NATECAL CALCIUM CARBONATECHOLECALCIFEROL 1 600 MG, UNK 0 600 MG TABLET
115339516 11533951 16 C NATECAL CALCIUM CARBONATECHOLECALCIFEROL 1 600 MG, (2 TABS IN MORNING, 2 TABS AT MIDDAY, 1 TAB AT DINNER) 0 TABLET
115339516 11533951 17 C BROMAZEPAM BROMAZEPAM 1 1 DF, 2X/DAY (1 TABLET EVERY 12 HOURS) 0 1 DF TABLET BID
115339516 11533951 18 C BROMAZEPAM BROMAZEPAM 1 1 DF, 2X/DAY (1 TABLET EVERY 12 HOURS) 0 1 DF TABLET BID
115339516 11533951 19 C SECALIP FENOFIBRATE 1 1 DF, 1X/DAY (1 TABLET EVERY 24 HOURS) 0 1 DF TABLET QD
115339516 11533951 20 C CRESTOR ROSUVASTATIN CALCIUM 1 5 MG, 1X/DAY (1 TABLET EVERY 24 HOURS) 0 5 MG TABLET QD
115339516 11533951 21 C ACFOL FOLIC ACID 1 1 DF, WEEKLY (1 TABLET DAILY (EVERY THURSDAY)) 0 1 DF TABLET /wk
115339516 11533951 22 C TRAMADOL. TRAMADOL 1 50 MG, 1X/DAY 0 50 MG TABLET QD
115339516 11533951 23 C TRAMADOL. TRAMADOL 1 50 MG, 1X/DAY 0 50 MG TABLET QD
115339516 11533951 24 C LANTUS INSULIN GLARGINE 1 20 IU, 1X/DAY (AT NIGHT) 0 20 IU QD
115339516 11533951 25 C TRAMADOL RETARD TRAMADOL 1 UNK, 2X/DAY 0 BID
115339516 11533951 26 C ATENOLOL. ATENOLOL 1 1 DF, 1X/DAY 0 1 DF QD
115339516 11533951 27 C ATENOLOL. ATENOLOL 1 1 DF, 1X/DAY 0 1 DF QD
115339516 11533951 28 C AMLODIPINE AMLODIPINE BESYLATE 1 UNK 0
115339516 11533951 29 C AMLODIPINE AMLODIPINE BESYLATE 1 UNK 0
115339516 11533951 30 C PANTOPRAZOLE PANTOPRAZOLE SODIUM 1 UNK 0
115339516 11533951 31 C PANTOPRAZOLE PANTOPRAZOLE SODIUM 1 UNK 0
115339516 11533951 32 C CEFALIN CEPHALEXIN 1 1.45 UNK, UNK 0
115339516 11533951 33 C HIDROFEROL CALCIFEDIOL 1 1 DF, MONTHLY 0 1 DF /month
115339516 11533951 34 C QUETIAPINE. QUETIAPINE 1 25 MG, 1X/DAY 0 25 MG QD
115339516 11533951 35 C QUETIAPINE. QUETIAPINE 1 25 MG, 1X/DAY 0 25 MG QD
115339516 11533951 36 C EXFORGE AMLODIPINE BESYLATEVALSARTAN 1 1 TABLET, DAILY 0 1 DF
115339516 11533951 37 C EXFORGE AMLODIPINE BESYLATEVALSARTAN 1 1 TABLET, DAILY 0 1 DF
115339516 11533951 38 C TORASEMIDE TORSEMIDE 1 1/2 TABLET, DAILY 0 TABLET
115339516 11533951 39 C TORASEMIDE TORSEMIDE 1 1/2 TABLET, DAILY 0 TABLET
115339516 11533951 40 C SILICONE OIL 2 1 SPOON EVERY 8H 0 1 DF TID
115339516 11533951 41 C TOUJEO INSULIN GLARGINE 1 16 IU, 1X/DAY (AT NIGHT) 0 16 IU QD
115339516 11533951 42 C TOUJEO INSULIN GLARGINE 1 14 IU, 1X/DAY (AT NIGHT) 0
115339516 11533951 43 C ENTEROSILICONA 2 1 SPOON EVERY 8 HOURS 0 1 DF TID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
115339516 11533951 1 Psoriatic arthropathy
115339516 11533951 6 Psoriatic arthropathy
115339516 11533951 7 Thyroid disorder
115339516 11533951 9 Hypertension
115339516 11533951 11 Flatulence
115339516 11533951 12 Depression
115339516 11533951 14 Vitamin D abnormal
115339516 11533951 15 Blood calcium abnormal
115339516 11533951 17 Depression
115339516 11533951 19 Hypercholesterolaemia
115339516 11533951 20 Blood triglycerides increased
115339516 11533951 22 Analgesic therapy
115339516 11533951 23 Pain
115339516 11533951 24 Diabetes mellitus
115339516 11533951 25 Analgesic therapy
115339516 11533951 26 Hypertension
115339516 11533951 28 Hypertension
115339516 11533951 32 Hypercholesterolaemia
115339516 11533951 34 Insomnia
115339516 11533951 35 Insomnia
115339516 11533951 36 Hypertension
115339516 11533951 38 Diuretic therapy
115339516 11533951 40 Flatulence
115339516 11533951 41 Diabetes mellitus
115339516 11533951 43 Flatulence

Outcome of event

Event ID CASEID OUTC COD
115339516 11533951 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
115339516 11533951 Arthralgia
115339516 11533951 Blood glucose abnormal
115339516 11533951 Condition aggravated
115339516 11533951 Disease recurrence
115339516 11533951 Drug effect incomplete
115339516 11533951 Drug interaction
115339516 11533951 Dysphagia
115339516 11533951 Fatigue
115339516 11533951 Headache
115339516 11533951 Hypertension
115339516 11533951 Injection site haematoma
115339516 11533951 Injection site haemorrhage
115339516 11533951 Injection site mass
115339516 11533951 Injection site urticaria
115339516 11533951 Musculoskeletal pain
115339516 11533951 Nasopharyngitis
115339516 11533951 Neck pain
115339516 11533951 Oropharyngeal pain
115339516 11533951 Pain
115339516 11533951 Pain in extremity
115339516 11533951 Pharyngeal erythema
115339516 11533951 Psoriasis
115339516 11533951 Psoriatic arthropathy
115339516 11533951 Rash pustular
115339516 11533951 Somnolence
115339516 11533951 Throat irritation
115339516 11533951 Urticaria
115339516 11533951 White blood cell count decreased

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
115339516 11533951 1 20150618 0
115339516 11533951 6 2014 2015 0