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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125354418 | 12535441 | 8 | F | 200111 | 20160908 | 20160707 | 20160916 | EXP | PHHY2016GB088550 | SANDOZ | 54.00 | YR | M | Y | 0.00000 | 20160916 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125354418 | 12535441 | 1 | PS | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | UNK | 76189 | ||||||||||
| 125354418 | 12535441 | 2 | SS | CARBIDOPA,ENTACAPONE,LEVODOPA | CARBIDOPAENTACAPONELEVODOPA | 1 | Unknown | 0 | |||||||||||
| 125354418 | 12535441 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, UNK | 2240 | MG | 0 | 30 | MG | ||||||
| 125354418 | 12535441 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, QD | 2240 | MG | 0 | 40 | MG | QD | |||||
| 125354418 | 12535441 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | 2240 | MG | 0 | 20 | MG | ||||||
| 125354418 | 12535441 | 6 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 2240 | MG | 0 | 20 | UMOL | ||||||
| 125354418 | 12535441 | 7 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 2240 | MG | 0 | 40 | MG | ||||||
| 125354418 | 12535441 | 8 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 2240 | MG | 0 | 30 | MG | ||||||
| 125354418 | 12535441 | 9 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | 936.72699 | MG | 0 | |||||||||
| 125354418 | 12535441 | 10 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 936.72699 | MG | 0 | ||||||||
| 125354418 | 12535441 | 11 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 936.72699 | MG | 0 | ||||||||
| 125354418 | 12535441 | 12 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 936.72699 | MG | 0 | ||||||||
| 125354418 | 12535441 | 13 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 936.72699 | MG | 0 | ||||||||
| 125354418 | 12535441 | 14 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | 936.72699 | MG | 0 | 20 | MG | QD | |||||
| 125354418 | 12535441 | 15 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | 936.72699 | MG | 0 | ||||||||
| 125354418 | 12535441 | 16 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 125354418 | 12535441 | 17 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 125354418 | 12535441 | 18 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | UNK | 0 | 10 | MG | |||||||||
| 125354418 | 12535441 | 19 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 0 | |||||||||||
| 125354418 | 12535441 | 20 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | STRENGTH: 2 MG/5 MG | 0 | ||||||||||
| 125354418 | 12535441 | 21 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | 0 | 40 | MG | ||||||||
| 125354418 | 12535441 | 22 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 125354418 | 12535441 | 23 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | UNK | 0 | 20 | MG | |||||||||
| 125354418 | 12535441 | 24 | C | GAMANIL | 2 | Unknown | 70 MG, BID | 4200 | MG | 0 | 70 | MG | BID | ||||||
| 125354418 | 12535441 | 25 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 40 MG, TID | 0 | 40 | MG | TID | |||||||
| 125354418 | 12535441 | 26 | C | SINEMET | CARBIDOPALEVODOPA | 1 | Unknown | 0 | |||||||||||
| 125354418 | 12535441 | 27 | C | SINEMET | CARBIDOPALEVODOPA | 1 | Unknown | 1 1/2 TABLETS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125354418 | 12535441 | 1 | Product used for unknown indication |
| 125354418 | 12535441 | 2 | Parkinson's disease |
| 125354418 | 12535441 | 3 | Depression |
| 125354418 | 12535441 | 9 | Depression |
| 125354418 | 12535441 | 16 | Depression |
| 125354418 | 12535441 | 17 | Product used for unknown indication |
| 125354418 | 12535441 | 19 | Depression |
| 125354418 | 12535441 | 22 | Product used for unknown indication |
| 125354418 | 12535441 | 24 | Depression |
| 125354418 | 12535441 | 25 | Product used for unknown indication |
| 125354418 | 12535441 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125354418 | 12535441 | HO |
| 125354418 | 12535441 | OT |
| 125354418 | 12535441 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125354418 | 12535441 | Abnormal dreams | |
| 125354418 | 12535441 | Aggression | |
| 125354418 | 12535441 | Agitation | |
| 125354418 | 12535441 | Anxiety disorder | |
| 125354418 | 12535441 | Apathy | |
| 125354418 | 12535441 | Decreased appetite | |
| 125354418 | 12535441 | Decreased interest | |
| 125354418 | 12535441 | Depression | |
| 125354418 | 12535441 | Feeling guilty | |
| 125354418 | 12535441 | Hallucination | |
| 125354418 | 12535441 | Hyperhidrosis | |
| 125354418 | 12535441 | Intrusive thoughts | |
| 125354418 | 12535441 | Muscle spasms | |
| 125354418 | 12535441 | Negative thoughts | |
| 125354418 | 12535441 | Nightmare | |
| 125354418 | 12535441 | Palpitations | |
| 125354418 | 12535441 | Panic attack | |
| 125354418 | 12535441 | Paraesthesia | |
| 125354418 | 12535441 | Parkinson's disease | |
| 125354418 | 12535441 | Psychomotor hyperactivity | |
| 125354418 | 12535441 | Restlessness | |
| 125354418 | 12535441 | Sleep disorder | |
| 125354418 | 12535441 | Suicidal ideation | |
| 125354418 | 12535441 | Tearfulness | |
| 125354418 | 12535441 | Terminal insomnia | |
| 125354418 | 12535441 | Tremor | |
| 125354418 | 12535441 | Trismus | |
| 125354418 | 12535441 | Weight decreased | |
| 125354418 | 12535441 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 125354418 | 12535441 | 1 | 200202 | 0 | ||
| 125354418 | 12535441 | 3 | 20011106 | 0 | ||
| 125354418 | 12535441 | 4 | 20011017 | 20011211 | 0 | |
| 125354418 | 12535441 | 5 | 20111129 | 0 | ||
| 125354418 | 12535441 | 6 | 20011129 | 0 | ||
| 125354418 | 12535441 | 7 | 20011017 | 20011211 | 0 | |
| 125354418 | 12535441 | 8 | 20111106 | 0 | ||
| 125354418 | 12535441 | 9 | 200007 | 20011217 | 0 | |
| 125354418 | 12535441 | 10 | 20011211 | 20011217 | 0 | |
| 125354418 | 12535441 | 11 | 200007 | 20011217 | 0 | |
| 125354418 | 12535441 | 12 | 20011116 | 0 | ||
| 125354418 | 12535441 | 13 | 20011129 | 0 | ||
| 125354418 | 12535441 | 14 | 2001 | 0 | ||
| 125354418 | 12535441 | 15 | 20011106 | 0 | ||
| 125354418 | 12535441 | 16 | 200007 | 20011217 | 0 | |
| 125354418 | 12535441 | 17 | 200805 | 0 | ||
| 125354418 | 12535441 | 18 | 200805 | 0 | ||
| 125354418 | 12535441 | 19 | 20011101 | 0 | ||
| 125354418 | 12535441 | 20 | 20011101 | 0 | ||
| 125354418 | 12535441 | 21 | 20011129 | 0 | ||
| 125354418 | 12535441 | 24 | 20011201 | 200201 | 0 | |
| 125354418 | 12535441 | 25 | 200007 | 0 |