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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126470911 | 12647091 | 1 | I | 201204 | 20160729 | 20160812 | 20160812 | EXP | ES-MLMSERVICE-20160729-0375403-1 | ES-LUPIN PHARMACEUTICALS INC.-2016-03490 | LUPIN | ALONSO-NAVARRO H, MONTES J, PLAZA-NIETO J, JIMENEZ-JIMENEZ F. CATAPLEXY POSSIBLY ASSOCIATED WITH LAMOTRIGINE. JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY. 2016;36(4):400-402. | 37.00 | YR | F | Y | 0.00000 | 20160812 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126470911 | 12647091 | 1 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG | Y | UNKNOWN | 0 | ||||||||
| 126470911 | 12647091 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Y | UNKNOWN | 0 | ||||||||||
| 126470911 | 12647091 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | UNKNOWN | 0 | 1.5 | MG | TID | |||||||
| 126470911 | 12647091 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | UNKNOWN | 0 | |||||||||||
| 126470911 | 12647091 | 5 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | INCREASING DOSES UP TO 200 MG | UNKNOWN | 78691 | |||||||||
| 126470911 | 12647091 | 6 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 100 MG | UNKNOWN | 78691 | |||||||||
| 126470911 | 12647091 | 7 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 200 MG | UNKNOWN | 78691 | |||||||||
| 126470911 | 12647091 | 8 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Unknown | 1000 MG | 0 | ||||||||||
| 126470911 | 12647091 | 9 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Unknown | 800 MG | 0 | ||||||||||
| 126470911 | 12647091 | 10 | C | Clordiazepoxide | 2 | Unknown | 5 MG | 0 | |||||||||||
| 126470911 | 12647091 | 11 | C | Clordiazepoxide | 2 | 0 | |||||||||||||
| 126470911 | 12647091 | 12 | C | Lormetazepam | LORMETAZEPAM | 1 | Unknown | 2 MG AT NIGHT | 0 | ||||||||||
| 126470911 | 12647091 | 13 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | 100 MG AT BEDTIME | 0 | ||||||||||
| 126470911 | 12647091 | 14 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | 100 MG AT BEDTIME | 0 | ||||||||||
| 126470911 | 12647091 | 15 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | 200 MG | 0 | ||||||||||
| 126470911 | 12647091 | 16 | C | Asenapine | ASENAPINE | 1 | Unknown | 5 MG | 0 | ||||||||||
| 126470911 | 12647091 | 17 | C | Asenapine | ASENAPINE | 1 | Unknown | 10 MG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126470911 | 12647091 | 1 | Mania |
| 126470911 | 12647091 | 2 | Bipolar disorder |
| 126470911 | 12647091 | 3 | Mania |
| 126470911 | 12647091 | 4 | Bipolar disorder |
| 126470911 | 12647091 | 5 | Bipolar disorder |
| 126470911 | 12647091 | 6 | Mania |
| 126470911 | 12647091 | 8 | Mania |
| 126470911 | 12647091 | 9 | Bipolar disorder |
| 126470911 | 12647091 | 10 | Mania |
| 126470911 | 12647091 | 11 | Bipolar disorder |
| 126470911 | 12647091 | 12 | Insomnia |
| 126470911 | 12647091 | 13 | Insomnia |
| 126470911 | 12647091 | 16 | Bipolar disorder |
| 126470911 | 12647091 | 17 | Mania |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126470911 | 12647091 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126470911 | 12647091 | Cataplexy | |
| 126470911 | 12647091 | Fall | |
| 126470911 | 12647091 | Galactorrhoea | |
| 126470911 | 12647091 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126470911 | 12647091 | 1 | 201203 | 201204 | 0 | |
| 126470911 | 12647091 | 3 | 201203 | 201205 | 0 | |
| 126470911 | 12647091 | 5 | 201207 | 0 | ||
| 126470911 | 12647091 | 7 | 201312 | 201405 | 0 | |
| 126470911 | 12647091 | 8 | 201203 | 201205 | 0 | |
| 126470911 | 12647091 | 9 | 201205 | 201207 | 0 | |
| 126470911 | 12647091 | 10 | 201203 | 201204 | 0 | |
| 126470911 | 12647091 | 12 | 201206 | 0 | ||
| 126470911 | 12647091 | 13 | 201208 | 0 | ||
| 126470911 | 12647091 | 14 | 201212 | 0 | ||
| 126470911 | 12647091 | 15 | 201306 | 201312 | 0 | |
| 126470911 | 12647091 | 16 | 201208 | 201212 | 0 | |
| 126470911 | 12647091 | 17 | 201302 | 0 |