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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100161594 | 10016159 | 4 | F | 2012 | 20160704 | 20140317 | 20160715 | EXP | GB-ACTAVISPR-2014-04568 | WATSON | 0.00 | M | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100161594 | 10016159 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 1250 MG, BID | U | 151139 | 78797 | 1250 | MG | FILM COATED TABLET | BID | ||||
| 100161594 | 10016159 | 2 | SS | Levetiracetam Actavis | LEVETIRACETAM | 1 | Unknown | 1250 MG, BID | U | CRB91X | 0 | 1250 | MG | FILM-COATED TABLET | BID | ||||
| 100161594 | 10016159 | 3 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 1250 MG, BID | 11H0047 | 0 | 1250 | MG | TABLET | BID | |||||
| 100161594 | 10016159 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 500 MG, BID | 0 | 500 | MG | TABLET | BID | ||||||
| 100161594 | 10016159 | 5 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 250 UNK, UNK | 0 | 250 | MG | TABLET | BID | ||||||
| 100161594 | 10016159 | 6 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | UNK - MORNING DOSE WAS REDUCED BY 250 MG (1000 MG QAM AND 1250 MG QPM) | 0 | TABLET | |||||||||
| 100161594 | 10016159 | 7 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 2250 MG, DAILY (1000 MG BID ALONG WITH 250 MG QAM FOR 7 DAYS) | 0 | 2250 | MG | TABLET | QD | ||||||
| 100161594 | 10016159 | 8 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 2500 MG, DAILY | 0 | 2500 | MG | TABLET | QD | ||||||
| 100161594 | 10016159 | 9 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 750 MG, BID | 0 | 750 | MG | TABLET | BID | ||||||
| 100161594 | 10016159 | 10 | C | CLINITAS HYDRATE | 2 | Unknown | 1 GTT DROP(S), DAILY | U | 0 | 1 | GTT | QD | |||||||
| 100161594 | 10016159 | 11 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Unknown | 250 MG, 3X/DAY (TID) | U | 0 | 250 | MG | TID | ||||||
| 100161594 | 10016159 | 12 | C | AZELASTINE | AZELASTINE | 1 | Unknown | 1 DF (1 PUFF), BID | U | 0 | 1 | DF | BID | ||||||
| 100161594 | 10016159 | 13 | C | BECLOMETASONE | BECLOMETHASONE DIPROPIONATE | 1 | Unknown | 2 DF (2 PUFFS), BID | U | 0 | 2 | DF | BID | ||||||
| 100161594 | 10016159 | 14 | C | BECONASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | 1 | Unknown | 2 DF 92 PUFFS), BID | U | 0 | 2 | DF | BID | ||||||
| 100161594 | 10016159 | 15 | C | CHLORAMPHENICOL | CHLORAMPHENICOL | 1 | Unknown | 1 GTT, 4X/DAY (QID) | U | 0 | 1 | GTT | |||||||
| 100161594 | 10016159 | 16 | C | CUPLEX /00797901/ | 2 | Unknown | UNK, QPM (APPLY AT NIGHT) | U | 0 | QD | |||||||||
| 100161594 | 10016159 | 17 | C | DOXYCYCLINE HYDROCHLORIDE | DOXYCYCLINE HYDROCHLORIDE | 1 | Unknown | 100 MG, ONCE DAILY (QD) | U | 0 | 100 | MG | QD | ||||||
| 100161594 | 10016159 | 18 | C | EPILIM | VALPROATE SODIUM | 1 | Oral | UNK (DOSE CHANGES) | U | 0 | MODIFIED RELEASE TABLET | ||||||||
| 100161594 | 10016159 | 19 | C | FLUCLOXACILLIN | FLUCLOXACILLIN | 1 | Unknown | 250 MG, 4X/DAY (QID), CONSEQUENNT DOSE CHANGES | U | 0 | 250 | MG | |||||||
| 100161594 | 10016159 | 20 | C | FLUTICASONE FUROATE | FLUTICASONE FUROATE | 1 | Nasal | 2 DF 91 PUFF TO EACH NOSTRIL), DAILY | U | 0 | 2 | DF | QD | ||||||
| 100161594 | 10016159 | 21 | C | HYPROMELLOSE | HYPROMELLOSES | 1 | Unknown | UNK (1-2 DROPS), TID | U | 0 | TID | ||||||||
| 100161594 | 10016159 | 22 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 400 MG, 3X/DAY (TID) | U | 0 | 400 | MG | TID | ||||||
| 100161594 | 10016159 | 23 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 15 MG, ONCE DAILY (QD) | U | 0 | 15 | MG | QD | ||||||
| 100161594 | 10016159 | 24 | C | LIQUIFILM TEARS | POLYVINYL ALCOHOL | 1 | Unknown | UNK (1-2 DROPS), PRN | U | 0 | |||||||||
| 100161594 | 10016159 | 25 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | UNK - WEANING (DIFFERENT DOSES ADMINISTERED) | U | 0 | |||||||||
| 100161594 | 10016159 | 26 | C | OLANZAPINE. | OLANZAPINE | 1 | Oral | 1 X 2.5 MG TAB ONCE DAILY, SLOWLY WEANED AND STOPPED | U | 0 | 1 | DF | TABLET | QD | |||||
| 100161594 | 10016159 | 27 | C | OPTIVE | CARBOXYMETHYLCELLULOSE SODIUMGLYCERIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 100161594 | 10016159 | 28 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 100161594 | 10016159 | 29 | C | PIROXICAM. | PIROXICAM | 1 | Unknown | UNK - APPLY 2-3 TIMES DAILY | U | 0 | |||||||||
| 100161594 | 10016159 | 30 | C | PROPRANOLOL HYDROCHLORIDE. | PROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 40 MG, ONCE DAILY (QD) | U | 0 | 40 | MG | QD | ||||||
| 100161594 | 10016159 | 31 | C | PSEUDOEPHEDRINE | PSEUDOEPHEDRINE | 1 | Unknown | 60 MG, 4X/DAY (QID) | U | 0 | 60 | MG | |||||||
| 100161594 | 10016159 | 32 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | 25 MG, UNK, THEN CONSEQUENT DOSE CHANGES | U | 0 | 25 | MG | |||||||
| 100161594 | 10016159 | 33 | C | RANITIDINE HYDROCHLORIDE. | RANITIDINE HYDROCHLORIDE | 1 | Unknown | 300 MG, 2X/DAY (BID) | U | 0 | 300 | MG | BID | ||||||
| 100161594 | 10016159 | 34 | C | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Unknown | 100 MG, UNK, AS DIRECTED | U | 0 | 100 | MG | |||||||
| 100161594 | 10016159 | 35 | C | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Unknown | 200 MG, UNK | U | 0 | 200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100161594 | 10016159 | 1 | Product used for unknown indication |
| 100161594 | 10016159 | 2 | Product used for unknown indication |
| 100161594 | 10016159 | 3 | Product used for unknown indication |
| 100161594 | 10016159 | 10 | Product used for unknown indication |
| 100161594 | 10016159 | 11 | Product used for unknown indication |
| 100161594 | 10016159 | 12 | Product used for unknown indication |
| 100161594 | 10016159 | 13 | Headache |
| 100161594 | 10016159 | 14 | Oropharyngeal pain |
| 100161594 | 10016159 | 15 | Product used for unknown indication |
| 100161594 | 10016159 | 16 | Skin papilloma |
| 100161594 | 10016159 | 17 | Product used for unknown indication |
| 100161594 | 10016159 | 18 | Product used for unknown indication |
| 100161594 | 10016159 | 19 | Product used for unknown indication |
| 100161594 | 10016159 | 20 | Sinus congestion |
| 100161594 | 10016159 | 21 | Dry eye |
| 100161594 | 10016159 | 22 | Back pain |
| 100161594 | 10016159 | 23 | Gastrooesophageal reflux disease |
| 100161594 | 10016159 | 24 | Product used for unknown indication |
| 100161594 | 10016159 | 25 | Depression |
| 100161594 | 10016159 | 26 | Depression |
| 100161594 | 10016159 | 27 | Dry eye |
| 100161594 | 10016159 | 28 | Pain |
| 100161594 | 10016159 | 29 | Product used for unknown indication |
| 100161594 | 10016159 | 30 | Product used for unknown indication |
| 100161594 | 10016159 | 31 | Product used for unknown indication |
| 100161594 | 10016159 | 32 | Depression |
| 100161594 | 10016159 | 33 | Product used for unknown indication |
| 100161594 | 10016159 | 34 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100161594 | 10016159 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100161594 | 10016159 | Aggression | |
| 100161594 | 10016159 | Agitation | |
| 100161594 | 10016159 | Anger | |
| 100161594 | 10016159 | Anxiety | |
| 100161594 | 10016159 | Complex partial seizures | |
| 100161594 | 10016159 | Confusional state | |
| 100161594 | 10016159 | Depression | |
| 100161594 | 10016159 | Dry eye | |
| 100161594 | 10016159 | Feeling abnormal | |
| 100161594 | 10016159 | Feeling of body temperature change | |
| 100161594 | 10016159 | Generalised tonic-clonic seizure | |
| 100161594 | 10016159 | Head injury | |
| 100161594 | 10016159 | Hypoaesthesia | |
| 100161594 | 10016159 | Learning disability | |
| 100161594 | 10016159 | Localised infection | |
| 100161594 | 10016159 | Malaise | |
| 100161594 | 10016159 | Memory impairment | |
| 100161594 | 10016159 | Nasopharyngitis | |
| 100161594 | 10016159 | Nervousness | |
| 100161594 | 10016159 | Pain in extremity | |
| 100161594 | 10016159 | Paranoia | |
| 100161594 | 10016159 | Petit mal epilepsy | |
| 100161594 | 10016159 | Pharyngitis | |
| 100161594 | 10016159 | Seizure | |
| 100161594 | 10016159 | Somnolence | |
| 100161594 | 10016159 | Stress | |
| 100161594 | 10016159 | Temporomandibular joint syndrome | |
| 100161594 | 10016159 | Testicular pain | |
| 100161594 | 10016159 | Therapeutic response unexpected | |
| 100161594 | 10016159 | Viral infection | |
| 100161594 | 10016159 | Vision blurred | |
| 100161594 | 10016159 | 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 |
|---|---|---|---|---|---|---|
| 100161594 | 10016159 | 4 | 20120718 | 0 | ||
| 100161594 | 10016159 | 5 | 2012 | 2012 | 0 | |
| 100161594 | 10016159 | 7 | 201212 | 201212 | 0 | |
| 100161594 | 10016159 | 8 | 201212 | 0 | ||
| 100161594 | 10016159 | 9 | 20121102 | 0 | ||
| 100161594 | 10016159 | 11 | 2010 | 0 | ||
| 100161594 | 10016159 | 12 | 2011 | 0 | ||
| 100161594 | 10016159 | 13 | 2007 | 0 | ||
| 100161594 | 10016159 | 14 | 2007 | 0 | ||
| 100161594 | 10016159 | 15 | 2012 | 0 | ||
| 100161594 | 10016159 | 16 | 2013 | 0 | ||
| 100161594 | 10016159 | 17 | 2011 | 0 | ||
| 100161594 | 10016159 | 18 | 2009 | 201206 | 0 | |
| 100161594 | 10016159 | 19 | 2014 | 0 | ||
| 100161594 | 10016159 | 20 | 2011 | 0 | ||
| 100161594 | 10016159 | 21 | 2013 | 0 | ||
| 100161594 | 10016159 | 22 | 2007 | 0 | ||
| 100161594 | 10016159 | 23 | 2007 | 0 | ||
| 100161594 | 10016159 | 24 | 2013 | 0 | ||
| 100161594 | 10016159 | 25 | 2012 | 0 | ||
| 100161594 | 10016159 | 26 | 2013 | 20131017 | 0 | |
| 100161594 | 10016159 | 27 | 2013 | 0 | ||
| 100161594 | 10016159 | 29 | 2011 | 0 | ||
| 100161594 | 10016159 | 30 | 2012 | 0 | ||
| 100161594 | 10016159 | 31 | 2007 | 0 | ||
| 100161594 | 10016159 | 33 | 2007 | 0 | ||
| 100161594 | 10016159 | 34 | 2010 | 0 | ||
| 100161594 | 10016159 | 35 | 2012 | 0 |