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
125369764 12536976 4 F 200201 20160810 20160707 20160817 EXP PHHY2016GB088742 SANDOZ 62.00 YR F Y 0.00000 20160817 CN GB GB

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
125369764 12536976 1 PS PAROXETINE HYDROCHLORIDE. PAROXETINE HYDROCHLORIDE 1 Unknown 20 MG, UNK U 75566 20 MG
125369764 12536976 2 SS PAROXETINE HYDROCHLORIDE. PAROXETINE HYDROCHLORIDE 1 Unknown 40 MG U 75566 40 MG
125369764 12536976 3 SS PAROXETINE HYDROCHLORIDE. PAROXETINE HYDROCHLORIDE 1 Unknown 30 MG, UNK U 75566 30 MG
125369764 12536976 4 SS PAROXETINE HYDROCHLORIDE. PAROXETINE HYDROCHLORIDE 1 Unknown 10 MG, UNK U 75566 10 MG
125369764 12536976 5 SS PAROXETINE HYDROCHLORIDE. PAROXETINE HYDROCHLORIDE 1 Unknown 5 MG, UNK U 75566 5 MG
125369764 12536976 6 SS SEROXAT PAROXETINE HYDROCHLORIDE 1 Unknown UNK U 0
125369764 12536976 7 SS PAXIL PAROXETINE HYDROCHLORIDE 1 Unknown U 0
125369764 12536976 8 C ATORVASTATIN ATORVASTATIN 1 Unknown U 0
125369764 12536976 9 C COCODAMOL ACETAMINOPHENCODEINE PHOSPHATE 1 Unknown UNK U 0
125369764 12536976 10 C DIAZEPAM. DIAZEPAM 1 Unknown U 0
125369764 12536976 11 C DIHYDROCODEINE DIHYDROCODEINE 1 Unknown UNK U 0
125369764 12536976 12 C DULOXETINE. DULOXETINE 1 Unknown U 0
125369764 12536976 13 C EFFEXOR VENLAFAXINE HYDROCHLORIDE 1 Unknown U 0
125369764 12536976 14 C EFFEXOR VENLAFAXINE HYDROCHLORIDE 1 Unknown 150 MG U 0 150 MG
125369764 12536976 15 C LEVOTHYROXINE SODIUM. LEVOTHYROXINE SODIUM 1 Unknown U 0
125369764 12536976 16 C MELATONIN MELATONIN 1 Unknown U 0
125369764 12536976 17 C MIRTAZAPINE. MIRTAZAPINE 1 Unknown U 0
125369764 12536976 18 C PREDNISOL//PREDNISOLONE 2 Unknown U 0
125369764 12536976 19 C PROMETHAZINE PROMETHAZINEPROMETHAZINE HYDROCHLORIDE 1 Unknown U 0
125369764 12536976 20 C QUETIAPINE. QUETIAPINE 1 Unknown UNK 0
125369764 12536976 21 C QUETIAPINE. QUETIAPINE 1 Unknown INCREASED TO 300 MG 0
125369764 12536976 22 C SALBUTAMOL ALBUTEROL 1 Unknown U 0
125369764 12536976 23 C THYROXINE LEVOTHYROXINE 1 Unknown U 0
125369764 12536976 24 C TIOTROPIUM TIOTROPIUM 1 Respiratory (inhalation) U 0
125369764 12536976 25 C TRAMADOL. TRAMADOL 1 Unknown U 0
125369764 12536976 26 C TRAZODONE TRAZODONE HYDROCHLORIDE 1 Unknown U 0
125369764 12536976 27 C XANAX ALPRAZOLAM 1 Unknown UNK U 0
125369764 12536976 28 C XANAX ALPRAZOLAM 1 Unknown 0.5 MG, TID U 0 .5 MG TID
125369764 12536976 29 C ZOPICLONE ZOPICLONE 1 Unknown U 0
125369764 12536976 30 C ZOPICLONE ZOPICLONE 1 Unknown 15 MG, UNK U 0 15 MG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125369764 12536976 1 Tearfulness
125369764 12536976 2 Emotional distress
125369764 12536976 6 Product used for unknown indication
125369764 12536976 7 Product used for unknown indication
125369764 12536976 8 Product used for unknown indication
125369764 12536976 9 Polyomavirus-associated nephropathy
125369764 12536976 10 Polyomavirus-associated nephropathy
125369764 12536976 11 Polyomavirus-associated nephropathy
125369764 12536976 12 Polyomavirus-associated nephropathy
125369764 12536976 13 Polyomavirus-associated nephropathy
125369764 12536976 15 Product used for unknown indication
125369764 12536976 16 Polyomavirus-associated nephropathy
125369764 12536976 17 Polyomavirus-associated nephropathy
125369764 12536976 18 Rash
125369764 12536976 19 Polyomavirus-associated nephropathy
125369764 12536976 20 Polyomavirus-associated nephropathy
125369764 12536976 22 Product used for unknown indication
125369764 12536976 23 Polyomavirus-associated nephropathy
125369764 12536976 24 Product used for unknown indication
125369764 12536976 25 Polyomavirus-associated nephropathy
125369764 12536976 26 Polyomavirus-associated nephropathy
125369764 12536976 27 Polyomavirus-associated nephropathy
125369764 12536976 29 Polyomavirus-associated nephropathy

Outcome of event

Event ID CASEID OUTC COD
125369764 12536976 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125369764 12536976 Agitation
125369764 12536976 Alopecia
125369764 12536976 Anorgasmia
125369764 12536976 Anxiety
125369764 12536976 Arthralgia
125369764 12536976 Asthenia
125369764 12536976 Confusional state
125369764 12536976 Decreased appetite
125369764 12536976 Depressed mood
125369764 12536976 Disturbance in attention
125369764 12536976 Drug withdrawal syndrome
125369764 12536976 Gait disturbance
125369764 12536976 Hallucination
125369764 12536976 Headache
125369764 12536976 Insomnia
125369764 12536976 Irritability
125369764 12536976 Lethargy
125369764 12536976 Libido decreased
125369764 12536976 Loss of libido
125369764 12536976 Malaise
125369764 12536976 Marital problem
125369764 12536976 Morbid thoughts
125369764 12536976 Nausea
125369764 12536976 Nightmare
125369764 12536976 Onychoclasis
125369764 12536976 Psychiatric symptom
125369764 12536976 Respiratory disorder
125369764 12536976 Restlessness
125369764 12536976 Sleep disorder
125369764 12536976 Tearfulness
125369764 12536976 Weight increased

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
125369764 12536976 2 20010516 20050701 0
125369764 12536976 6 20010516 0
125369764 12536976 7 20010516 0
125369764 12536976 10 198504 0
125369764 12536976 13 20020106 0
125369764 12536976 15 20080515 0
125369764 12536976 16 200708 0
125369764 12536976 17 200308 0
125369764 12536976 19 200107 0
125369764 12536976 20 200703 0
125369764 12536976 23 20080515 0
125369764 12536976 25 200712 0
125369764 12536976 26 20020808 0
125369764 12536976 27 20011206 0
125369764 12536976 29 200111 0