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
122498733 12249873 3 F 2016 20160707 20160408 20160715 EXP US-JNJFOC-20160405992 JANSSEN 0.00 E F Y 85.28000 KG 20160715 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
122498733 12249873 1 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N 15H191P1 0 300 MG LYOPHILIZED POWDER
122498733 12249873 2 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N 15H191P1 0 300 MG LYOPHILIZED POWDER
122498733 12249873 3 PS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N 15H191P1 103772 300 MG LYOPHILIZED POWDER
122498733 12249873 4 C ENALAPRIL W/HYDROCHLOROTHIAZIDE ENALAPRILHYDROCHLOROTHIAZIDE 1 Oral 0 TABLET
122498733 12249873 5 C ENALAPRIL W/HYDROCHLOROTHIAZIDE ENALAPRILHYDROCHLOROTHIAZIDE 1 Oral 10-25 MG, FOR 90 DAYS. 0 TABLET
122498733 12249873 6 C FOLIC ACID. FOLIC ACID 1 Oral FOR 90 DAYS. 0 1 MG TABLET BID
122498733 12249873 7 C FOLIC ACID. FOLIC ACID 1 Oral 0 1 MG TABLET BID
122498733 12249873 8 C NEURONTIN GABAPENTIN 1 Oral FOR 90 DAYS. 0 300 MG CAPSULE
122498733 12249873 9 C VITAMIN C ASCORBIC ACID 1 Oral 0 500 MG CAPSULE QD
122498733 12249873 10 C VITAMIN B12 CYANOCOBALAMIN 1 Oral 0 1000 UG TABLET QD
122498733 12249873 11 C VITAMIN B12 CYANOCOBALAMIN 1 Oral 0 TABLET
122498733 12249873 12 C VITAMIN D3 CHOLECALCIFEROL 1 Oral 0 50000 DF CAPSULE BIW
122498733 12249873 13 C FISH OIL FISH OIL 1 Oral 0 1200 MG CAPSULE BID
122498733 12249873 14 C DHEA PRASTERONE 1 Oral 0 25 MG CAPSULE
122498733 12249873 15 C LUTEIN LUTEIN 1 Oral 0 20 MG CAPSULE QD
122498733 12249873 16 C MAGNESIUM GLUCONATE MAGNESIUM GLUCONATE 1 Oral 0 200 MG TABLET
122498733 12249873 17 C PREDNISONE. PREDNISONE 1 Oral 1-2 TABLET IN THE MORNING AS DIRECTED FOR 30 DAYS. 0 5 MG TABLET
122498733 12249873 18 C TRAZODONE HYDROCHLORIDE. TRAZODONE HYDROCHLORIDE 1 Oral 0 50 MG TABLET
122498733 12249873 19 C TRAZODONE HYDROCHLORIDE. TRAZODONE HYDROCHLORIDE 1 Oral FOR 30 DAYS. 0 150 MG TABLET
122498733 12249873 20 C TRAZODONE HYDROCHLORIDE. TRAZODONE HYDROCHLORIDE 1 Oral 0 50 MG TABLET
122498733 12249873 21 C TRAZODONE HYDROCHLORIDE. TRAZODONE HYDROCHLORIDE 1 Oral FOR 30 DAYS. 0 150 MG TABLET
122498733 12249873 22 C IRON IRON 1 Oral 1-2 TIMES DAILY FOR 90 DAYS. 0 325 MG TABLET
122498733 12249873 23 C PROTONIX PANTOPRAZOLE SODIUM 1 Oral PACKETS FOR 90 DAYS 0 40 MG UNSPECIFIED
122498733 12249873 24 C LEVOTHYROXINE SODIUM. LEVOTHYROXINE SODIUM 1 Oral FOR 90 DAYS 0 75 UG TABLET QD
122498733 12249873 25 C TIZANIDINE HCL TIZANIDINE HYDROCHLORIDE 1 Oral 1-2, 1-2 HOURS BEFORE HS AS DIRECTED FOR 90 DAYS 0 4 MG TABLET
122498733 12249873 26 C HYDROXYCHLOROQUINE SULFATE. HYDROXYCHLOROQUINE SULFATE 1 Oral FOR 90 DAYS. 0 200 MG TABLET BID
122498733 12249873 27 C HYDROXYCHLOROQUINE SULFATE. HYDROXYCHLOROQUINE SULFATE 1 Oral FOR 90 DAYS. 0 200 MG TABLET BID
122498733 12249873 28 C AMBIEN ZOLPIDEM TARTRATE 1 Oral FOR 30 DAYS 0 10 MG TABLET
122498733 12249873 29 C AMBIEN ZOLPIDEM TARTRATE 1 Oral FOR 30 DAYS 0 5 MG TABLET
122498733 12249873 30 C METHOTREXATE. METHOTREXATE 1 Oral FOR 90 DAYS 0 2.5 MG TABLET /wk
122498733 12249873 31 C METHOTREXATE. METHOTREXATE 1 Oral FOR 90 DAYS 0 2.5 MG TABLET /wk
122498733 12249873 32 C METHOTREXATE. METHOTREXATE 1 Oral FOR 90 DAYS 0 2.5 MG TABLET /wk
122498733 12249873 33 C METHOTREXATE. METHOTREXATE 1 Oral FOR 90 DAYS 0 2.5 MG TABLET /wk
122498733 12249873 34 C RITUXAN RITUXIMAB 1 Intravenous (not otherwise specified) 500MG/50ML SOLUTION 0 1000 MG SOLUTION
122498733 12249873 35 C ACYCLOVIR. ACYCLOVIR 1 Unknown 0 800 MG TABLET
122498733 12249873 36 C AZELASTINE HCL AZELASTINE HYDROCHLORIDE 1 Unknown 2 SPRAYS EACH SIDE IN THE AM 0 137 UG BID
122498733 12249873 37 C AZITHROMYCIN ANHYDROUS. AZITHROMYCIN ANHYDROUS 1 Unknown 0 250 MG TABLET QD
122498733 12249873 38 C AZITHROMYCIN ANHYDROUS. AZITHROMYCIN ANHYDROUS 1 Unknown 0 250 MG TABLET BID
122498733 12249873 39 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral 0 25 MG CAPSULE
122498733 12249873 40 C CALCIUM PLUS VITAMIN D CALCIUMVITAMIN D 1 Oral 600-200MG UNIT TABLET 1 ORAL DAILY 0 TABLET
122498733 12249873 41 C CIPROFLOXACIN HCL CIPROFLOXACIN HYDROCHLORIDE 1 Unknown 0 100 MG TABLET BID
122498733 12249873 42 C DOXYCYCLINE HYCLATE. DOXYCYCLINE HYCLATE 1 Unknown FOR 10 DAYS 0 100 MG CAPSULE BID
122498733 12249873 43 C ESTRADERM ESTRADIOL 1 Transdermal ON SUNDAY 0 .1 MG PATCH /wk
122498733 12249873 44 C ESTRADERM ESTRADIOL 1 Transdermal 0 .05 MG PATCH BIW
122498733 12249873 45 C FLEXERIL CYCLOBENZAPRINE HYDROCHLORIDE 1 Unknown FOR 30 DAYS 0 10 MG TABLET
122498733 12249873 46 C FLONASE FLUTICASONE PROPIONATE 1 Unknown FOR 30 DAYS 0 50 UG SUSPENSION QD
122498733 12249873 47 C ACETAMINOPHENHYDROCODONE BITARTRATE ACETAMINOPHENHYDROCODONE BITARTRATE 1 Unknown FOR 30 DAYS 0 1 DF TABLET BID
122498733 12249873 48 C LEVAQUIN LEVOFLOXACIN 1 Unknown FOR 5 DAYS 0 500 MG TABLET QD
122498733 12249873 49 C LEVOTHROID LEVOTHYROXINE SODIUM 1 Unknown FOR 30 DAYS 0 50 UG TABLET QD
122498733 12249873 50 C LIDOCAINE. LIDOCAINE 1 Unknown FOR 30 DAYS 0 5 PCT OINTMENT BID
122498733 12249873 51 C LIDODERM LIDOCAINE 1 Unknown FOR 30 DAYS 1-3 PATCH TWELVE HOURS ON TWELVE HOURS OFF 0 5 PCT PATCH
122498733 12249873 52 C LISINOPRIL. LISINOPRIL 1 Oral 0 30 MG TABLET QD
122498733 12249873 53 C LORATADINE. LORATADINE 1 Oral 0 10 MG TABLET QD
122498733 12249873 54 C LORATADINE. LORATADINE 1 Oral 0 10 MG ORODISPERSIBLE TABLET
122498733 12249873 55 C LYRICA PREGABALIN 1 Unknown FOR 30 DAYS 0 50 MG CAPSULE
122498733 12249873 56 C METAXALONE. METAXALONE 1 Unknown FOR 30 DAYS 0 800 MG TABLET TID
122498733 12249873 57 C METAXALONE. METAXALONE 1 Unknown FOR 30 DAYS 0 800 MG TABLET TID
122498733 12249873 58 C MOBIC MELOXICAM 1 Unknown FOR 90 DAYS 0 7.5 MG TABLET QD
122498733 12249873 59 C NASONEX MOMETASONE FUROATE 1 Nasal 0 50 MG SUSPENSION
122498733 12249873 60 C NEURONTIN GABAPENTIN 1 Oral 0 100 MG CAPSULE BID
122498733 12249873 61 C NEURONTIN GABAPENTIN 1 Oral FOR 90 DAYS 0 300 MG CAPSULE BID
122498733 12249873 62 C NEURONTIN GABAPENTIN 1 Oral FOR 30 DAYS 0 600 MG CAPSULE
122498733 12249873 63 C NEURONTIN GABAPENTIN 1 Oral 0 100 MG CAPSULE BID
122498733 12249873 64 C NEURONTIN GABAPENTIN 1 Oral FOR 90 DAYS 0 300 MG CAPSULE BID
122498733 12249873 65 C NEURONTIN GABAPENTIN 1 Oral FOR 30 DAYS 0 600 MG CAPSULE
122498733 12249873 66 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 Unknown FOR 30 DAYS 0 20 MG CAPSULE BID
122498733 12249873 67 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 Unknown FOR 30 DAYS 0 20 MG TABLET BID
122498733 12249873 68 C PROAIR HFA ALBUTEROL SULFATE 1 Unknown 1 AEROSOL SOLN 2-3 TIMES PER DAY 0 108 UG UNSPECIFIED
122498733 12249873 69 C SINGULAIR MONTELUKAST SODIUM 1 Oral 0 10 MG TABLET
122498733 12249873 70 C SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLETRIMETHOPRIM 1 Unknown FOR 10 DAYS 800-160MG 0 TABLET
122498733 12249873 71 C ULTRAM TRAMADOL HYDROCHLORIDE 1 FOR 30 DAYS 0 50 MG TID
122498733 12249873 72 C VAGIFEM ESTRADIOL 1 Vaginal 0 10 UG TABLET BIW
122498733 12249873 73 C VICODIN ACETAMINOPHENHYDROCODONE BITARTRATE 1 Unknown 0 1 DF TABLET BID
122498733 12249873 74 C VICODIN ACETAMINOPHENHYDROCODONE BITARTRATE 1 Unknown 0 1 DF TABLET BID
122498733 12249873 75 C VITAMIN D CHOLECALCIFEROL 1 Oral 50000 UNIT FOR 30 DAYS 0 1 DF CAPSULE BIW
122498733 12249873 76 C VITAMIN D CHOLECALCIFEROL 1 Oral 2000 UNIT 0 4 DF CAPSULE QD
122498733 12249873 77 C VITAMIN D CHOLECALCIFEROL 1 Oral 1000 UNIT FOR 30 DAYS 0 1 DF CAPSULE QD
122498733 12249873 78 C VITAMIN E .ALPHA.-TOCOPHEROL 1 Oral 400 UNIT 0 1 DF QD
122498733 12249873 79 C METHYLPREDNISOLONE ACETATE. METHYLPREDNISOLONE ACETATE 1 Unknown 0 UNSPECIFIED
122498733 12249873 80 C METHYLPREDNISOLONE ACETATE. METHYLPREDNISOLONE ACETATE 1 Unknown 0 UNSPECIFIED
122498733 12249873 81 C METHYLPREDNISOLONE ACETATE. METHYLPREDNISOLONE ACETATE 1 Unknown 0 UNSPECIFIED
122498733 12249873 82 C METHYLPREDNISOLONE ACETATE. METHYLPREDNISOLONE ACETATE 1 Unknown 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
122498733 12249873 1 Rheumatoid arthritis
122498733 12249873 2 Rheumatoid arthritis
122498733 12249873 3 Rheumatoid arthritis
122498733 12249873 4 Hypertension
122498733 12249873 5 Hypertension
122498733 12249873 6 Rheumatoid arthritis
122498733 12249873 7 Rheumatoid arthritis
122498733 12249873 8 Rheumatoid arthritis
122498733 12249873 18 Rheumatoid arthritis
122498733 12249873 19 Rheumatoid arthritis
122498733 12249873 20 Insomnia
122498733 12249873 21 Insomnia
122498733 12249873 22 Microcytic anaemia
122498733 12249873 23 Gastrooesophageal reflux disease
122498733 12249873 24 Hypothyroidism
122498733 12249873 25 Insomnia
122498733 12249873 26 Rheumatoid arthritis
122498733 12249873 27 Rheumatoid arthritis
122498733 12249873 30 Spondyloarthropathy
122498733 12249873 31 Spondyloarthropathy
122498733 12249873 32 Rheumatoid arthritis
122498733 12249873 33 Rheumatoid arthritis
122498733 12249873 35 Herpes zoster
122498733 12249873 37 Acute sinusitis
122498733 12249873 38 Acute sinusitis
122498733 12249873 41 Urinary tract infection
122498733 12249873 45 Insomnia
122498733 12249873 46 Bronchitis
122498733 12249873 47 Rheumatoid arthritis
122498733 12249873 48 Bronchitis
122498733 12249873 49 Hypothyroidism
122498733 12249873 50 Rheumatoid arthritis
122498733 12249873 51 Post herpetic neuralgia
122498733 12249873 55 Neck pain
122498733 12249873 56 Fibromyalgia
122498733 12249873 57 Fibromyalgia
122498733 12249873 58 Rheumatoid arthritis
122498733 12249873 60 Fibromyalgia
122498733 12249873 61 Fibromyalgia
122498733 12249873 62 Fibromyalgia
122498733 12249873 63 Fibromyalgia
122498733 12249873 64 Fibromyalgia
122498733 12249873 65 Fibromyalgia
122498733 12249873 66 Rheumatoid arthritis
122498733 12249873 67 Spondyloarthropathy
122498733 12249873 68 Bronchitis
122498733 12249873 70 Dysuria
122498733 12249873 73 Fibromyalgia
122498733 12249873 74 Fibromyalgia

Outcome of event

Event ID CASEID OUTC COD
122498733 12249873 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
122498733 12249873 Fatigue
122498733 12249873 Lupus-like syndrome
122498733 12249873 Muscular weakness
122498733 12249873 Rheumatoid arthritis

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
122498733 12249873 1 20151212 0
122498733 12249873 2 20160218 201604 0
122498733 12249873 3 2009 0
122498733 12249873 4 20151214 0
122498733 12249873 5 20160428 0
122498733 12249873 6 20160428 0
122498733 12249873 7 20150701 0
122498733 12249873 8 20160428 0
122498733 12249873 10 20090330 0
122498733 12249873 17 20160404 0
122498733 12249873 18 20120403 0
122498733 12249873 19 20151214 0
122498733 12249873 20 20120403 0
122498733 12249873 21 20151214 0
122498733 12249873 22 20140923 0
122498733 12249873 23 20150701 0
122498733 12249873 24 20150701 0
122498733 12249873 25 20160208 0
122498733 12249873 26 20160208 0
122498733 12249873 27 20140220 0
122498733 12249873 28 20160331 0
122498733 12249873 29 20150217 0
122498733 12249873 30 20090917 0
122498733 12249873 31 20151214 0
122498733 12249873 32 20090917 0
122498733 12249873 33 20151214 0
122498733 12249873 34 20160518 0
122498733 12249873 35 20110808 0
122498733 12249873 41 20090330 0
122498733 12249873 42 20110201 0
122498733 12249873 43 20120530 0
122498733 12249873 45 20121212 0
122498733 12249873 46 20121003 0
122498733 12249873 47 20130605 0
122498733 12249873 48 20121003 0
122498733 12249873 49 20130731 0
122498733 12249873 50 20111212 0
122498733 12249873 51 20120207 0
122498733 12249873 55 20090903 0
122498733 12249873 56 20131205 0
122498733 12249873 57 20131205 0
122498733 12249873 58 20140923 0
122498733 12249873 60 20100816 20101206 0
122498733 12249873 61 20150701 0
122498733 12249873 62 20130605 0
122498733 12249873 63 20100816 20101206 0
122498733 12249873 64 20150701 0
122498733 12249873 65 20130605 0
122498733 12249873 66 20111020 0
122498733 12249873 67 20100923 0
122498733 12249873 68 20121003 0
122498733 12249873 70 20160208 0
122498733 12249873 71 20110829 0
122498733 12249873 72 20050420 0
122498733 12249873 73 20130116 0
122498733 12249873 74 20130116 0
122498733 12249873 75 20100414 0
122498733 12249873 76 20090129 0
122498733 12249873 77 20090813 0
122498733 12249873 78 20081211 0
122498733 12249873 79 20141029 0
122498733 12249873 80 20150217 0
122498733 12249873 81 20160505 0
122498733 12249873 82 20160330 0