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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127711321 | 12771132 | 1 | I | 20081204 | 20160915 | 20160922 | 20160922 | EXP | DK-DKMA-ADR 23629715 | PHHY2016DK127736 | NOVARTIS | 43.77 | YR | F | Y | 0.00000 | 20160922 | OT | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127711321 | 12771132 | 1 | PS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | UNK | U | 10187 | |||||||||
| 127711321 | 12771132 | 2 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | U | 10187 | 30 | MG | QD | ||||||
| 127711321 | 12771132 | 3 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 15 MG, QD | U | 10187 | 15 | MG | QD | ||||||
| 127711321 | 12771132 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 10 MG, 2-3 TIMES A DAY | U | 10187 | 10 | MG | |||||||
| 127711321 | 12771132 | 5 | C | NOVOFEM | ESTRADIOL HEMIHYDRATENORETHINDRONE ACETATE | 1 | Unknown | U | 0 | ||||||||||
| 127711321 | 12771132 | 6 | C | DERMOVAT | CLOBETASOL | 1 | Unknown | U | 0 | ||||||||||
| 127711321 | 12771132 | 7 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 127711321 | 12771132 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 0 | |||||||||||
| 127711321 | 12771132 | 9 | C | OMEPRAZOL//OMEPRAZOLE | 2 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127711321 | 12771132 | 1 | Narcolepsy |
| 127711321 | 12771132 | 5 | Menopausal disorder |
| 127711321 | 12771132 | 6 | Dermatitis atopic |
| 127711321 | 12771132 | 7 | Pharyngitis |
| 127711321 | 12771132 | 8 | Sleep disorder |
| 127711321 | 12771132 | 9 | Gastrointestinal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127711321 | 12771132 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127711321 | 12771132 | Abdominal pain | |
| 127711321 | 12771132 | Depression | |
| 127711321 | 12771132 | Dermatitis atopic | |
| 127711321 | 12771132 | Fatigue | |
| 127711321 | 12771132 | Feeling cold | |
| 127711321 | 12771132 | Glaucoma | |
| 127711321 | 12771132 | Headache | |
| 127711321 | 12771132 | Hot flush | |
| 127711321 | 12771132 | Libido decreased | |
| 127711321 | 12771132 | Mood altered | |
| 127711321 | 12771132 | Mood swings | |
| 127711321 | 12771132 | Muscle contractions involuntary | |
| 127711321 | 12771132 | Muscle tightness | |
| 127711321 | 12771132 | Muscular weakness | |
| 127711321 | 12771132 | Myalgia | |
| 127711321 | 12771132 | Nervousness | |
| 127711321 | 12771132 | Oropharyngeal pain | |
| 127711321 | 12771132 | Palpitations | |
| 127711321 | 12771132 | Pharyngitis | |
| 127711321 | 12771132 | Pruritus | |
| 127711321 | 12771132 | Restlessness | |
| 127711321 | 12771132 | Sleep disorder | |
| 127711321 | 12771132 | Tachyphrenia | |
| 127711321 | 12771132 | Tremor | |
| 127711321 | 12771132 | Vision blurred | |
| 127711321 | 12771132 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 127711321 | 12771132 | 1 | 1991 | 0 | ||
| 127711321 | 12771132 | 8 | 20101013 | 20101015 | 0 |