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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127998191 | 12799819 | 1 | I | 20160920 | 20160930 | 20160930 | EXP | US-INDIVIOR LIMITED-INDV-095072-2016 | INDIVIOR | 0.00 | M | Y | 0.00000 | 20160930 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127998191 | 12799819 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Unknown | 16 MG | U | U | UNKNOWN | 22410 | |||||||
| 127998191 | 12799819 | 2 | SS | VIAGRA | SILDENAFIL CITRATE | 1 | Oral | 100 MG TABLET AT A DOSE OF 1 TABLET AS NECESSARY APPROXIMATELY 1 HOUR BEFORE SEXUAL ACTIVITY | U | U | 0 | ||||||||
| 127998191 | 12799819 | 3 | SS | LYRICA | PREGABALIN | 1 | Oral | 150 MG CAPSULES AT A DOSE OF 1 CAPSULE 3 TIMES | U | U | 0 | ||||||||
| 127998191 | 12799819 | 4 | SS | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 10 MG DAILY | U | U | 0 | ||||||||
| 127998191 | 12799819 | 5 | SS | CHANTIX | VARENICLINE TARTRATE | 1 | Oral | 1 MG TWICE DAILY | U | U | 0 | ||||||||
| 127998191 | 12799819 | 6 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | Oral | 10 MG TABLET AT A DOSE OF 1 TABLET AT BEDTIME | 0 | ||||||||||
| 127998191 | 12799819 | 7 | C | GLYCOLAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | POWDER FOR ORAL SOLUTION 17 GM IN 8 OUNCES OF WATER DAILY | 0 | ||||||||||
| 127998191 | 12799819 | 8 | C | NICODERM CQ | NICOTINE | 1 | Transdermal | 21MG TRANSDERMAL PATCH, 1 PATCH TO HAIRLESS AREA ON UPPER ARMS DAILY AND TO REMOVE AFTER 24 HOURS | 0 | ||||||||||
| 127998191 | 12799819 | 9 | C | NICORETTE | NICOTINE | 1 | Oral | 2MG/1SQUAR GUM 1 EACH (2 MG TOTAL) EVERY 2 HOURS AS NEEDED (MAX DAILY DOSE 24 MG) | 0 | ||||||||||
| 127998191 | 12799819 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 325 MG TABLET AT A DOSE OF 2 TABLETS 4 TIMES DAILY AS NEEDED | 0 | ||||||||||
| 127998191 | 12799819 | 11 | C | TIMOPTIC | TIMOLOL MALEATE | 1 | Ophthalmic | 1 DROP TO AFFECTED EYES TWICE DAILY | 0 | ||||||||||
| 127998191 | 12799819 | 12 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Intramuscular | 1,000 MCG/1 ML INJECTION AT A DOSE OF 1 ML EVERY WEEK | 0 | ||||||||||
| 127998191 | 12799819 | 13 | C | METHADONE HYDROCHLORIDE. | METHADONE HYDROCHLORIDE | 1 | Oral | 10 MG TABLET AT A DOSE OF 1 TABLET EVERY 8 HOURS AS NEEDED | 0 | ||||||||||
| 127998191 | 12799819 | 14 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 25 MG TABLET 1 TABLET DAILY | 0 | ||||||||||
| 127998191 | 12799819 | 15 | C | RALTEGRAVIR. | RALTEGRAVIR | 1 | Oral | 400MG TABLET AT A DOSE OF 1 TABLET TWICE DAILY | 0 | ||||||||||
| 127998191 | 12799819 | 16 | C | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | 300MG/200MG TABLET AT A DOSE OF 1 TABLET DAILY | 0 | ||||||||||
| 127998191 | 12799819 | 17 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10MG TABLET AT A DOSE OF 1 TABLET EACH EVENING | 0 | ||||||||||
| 127998191 | 12799819 | 18 | C | NORVIR | RITONAVIR | 1 | Unknown | 100MG TABLET AT A DOSE OF ONE TABLET DALLY | 0 | ||||||||||
| 127998191 | 12799819 | 19 | C | PREZISTA | DARUNAVIR ETHANOLATE | 1 | Oral | 800MG TABLET AT A DOSE OF 1 TABLET DAILY | 0 | ||||||||||
| 127998191 | 12799819 | 20 | C | RITONAVIR. | RITONAVIR | 1 | Unknown | 100 MG | 0 | ||||||||||
| 127998191 | 12799819 | 21 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | 100 UNITS/1 ML INJECTION INJECT 40 UNITS SQ Q AM AND 40 UNITS QHS | 0 | ||||||||||
| 127998191 | 12799819 | 22 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | BD PEN NEEDLE SHORT 31G X 5/16 SED AS DIRECTED 4 TIMES DALLY | 0 | ||||||||||
| 127998191 | 12799819 | 23 | C | MULTIVITAMIN /07504101/ | VITAMINS | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 127998191 | 12799819 | 24 | C | NASACORT AQ | TRIAMCINOLONE ACETONIDE | 1 | Nasal | 55MCG/1ACTUATION NASAL SPRAY 2 SPRAYS DALLY | 0 | ||||||||||
| 127998191 | 12799819 | 25 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | Oral | 90MCG/1 ACTUATION ORAL INHALER 2 PUFFS BY MOUTH Q4 TO 6 HOUR | 0 | ||||||||||
| 127998191 | 12799819 | 26 | C | HUMALOG | INSULIN LISPRO | 1 | Unknown | 100 UNITS/1 ML PEN SYSTEM, DISPOSABLE 20 UNITS TID FOR B8G}100 PLUS 5 U ADDITIONAL FOR BG}300 | 0 | ||||||||||
| 127998191 | 12799819 | 27 | C | HUMALOG | INSULIN LISPRO | 1 | Unknown | BD PEN NEEDLE SHORT 31G X 5/16 SED AS DIRECTED 4 TIMES DALLY | 0 | ||||||||||
| 127998191 | 12799819 | 28 | C | LAC-HYDRIN | AMMONIUM LACTATE | 1 | Transdermal | 12% LOTION APPLY SUFFICIENT AMOUNT TO AFFECTED AREA ONCE DALLY AND RUB IN | 0 | ||||||||||
| 127998191 | 12799819 | 29 | SS | LISINOPRIL. | LISINOPRIL | 1 | Oral | 40 MG, ONE TABLET DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127998191 | 12799819 | 1 | Drug dependence |
| 127998191 | 12799819 | 2 | Product used for unknown indication |
| 127998191 | 12799819 | 3 | Product used for unknown indication |
| 127998191 | 12799819 | 4 | Product used for unknown indication |
| 127998191 | 12799819 | 5 | Product used for unknown indication |
| 127998191 | 12799819 | 6 | Product used for unknown indication |
| 127998191 | 12799819 | 7 | Product used for unknown indication |
| 127998191 | 12799819 | 8 | Product used for unknown indication |
| 127998191 | 12799819 | 9 | Smoking cessation therapy |
| 127998191 | 12799819 | 10 | Pain |
| 127998191 | 12799819 | 11 | Product used for unknown indication |
| 127998191 | 12799819 | 12 | Product used for unknown indication |
| 127998191 | 12799819 | 13 | Pain |
| 127998191 | 12799819 | 14 | Product used for unknown indication |
| 127998191 | 12799819 | 15 | Product used for unknown indication |
| 127998191 | 12799819 | 16 | Product used for unknown indication |
| 127998191 | 12799819 | 17 | Product used for unknown indication |
| 127998191 | 12799819 | 18 | Product used for unknown indication |
| 127998191 | 12799819 | 19 | Product used for unknown indication |
| 127998191 | 12799819 | 20 | Product used for unknown indication |
| 127998191 | 12799819 | 21 | Product used for unknown indication |
| 127998191 | 12799819 | 23 | Product used for unknown indication |
| 127998191 | 12799819 | 24 | Product used for unknown indication |
| 127998191 | 12799819 | 25 | Product used for unknown indication |
| 127998191 | 12799819 | 26 | Product used for unknown indication |
| 127998191 | 12799819 | 28 | Product used for unknown indication |
| 127998191 | 12799819 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127998191 | 12799819 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127998191 | 12799819 | Affective disorder | |
| 127998191 | 12799819 | Anger | |
| 127998191 | 12799819 | Anogenital dysplasia | |
| 127998191 | 12799819 | Back pain | |
| 127998191 | 12799819 | Cough | |
| 127998191 | 12799819 | Drug dependence | |
| 127998191 | 12799819 | Erectile dysfunction | |
| 127998191 | 12799819 | Essential hypertension | |
| 127998191 | 12799819 | Foot fracture | |
| 127998191 | 12799819 | Gastrooesophageal reflux disease | |
| 127998191 | 12799819 | Generalised anxiety disorder | |
| 127998191 | 12799819 | Hyperlipidaemia | |
| 127998191 | 12799819 | Hypertension | |
| 127998191 | 12799819 | Hypogonadism male | |
| 127998191 | 12799819 | Insomnia | |
| 127998191 | 12799819 | Muscular weakness | |
| 127998191 | 12799819 | Neuropathy peripheral | |
| 127998191 | 12799819 | Osteoporosis | |
| 127998191 | 12799819 | Pain in extremity | |
| 127998191 | 12799819 | Post-traumatic stress disorder | |
| 127998191 | 12799819 | Restless legs syndrome | |
| 127998191 | 12799819 | Seizure | |
| 127998191 | 12799819 | Vitamin B12 deficiency | |
| 127998191 | 12799819 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |