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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 73823004 | 7382300 | 4 | F | 2006 | 20160708 | 20100510 | 20160715 | EXP | FI-PFIZER INC-2007078093 | PFIZER | 46.00 | YR | M | Y | 0.00000 | 20160715 | LW | FI | FI |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 73823004 | 7382300 | 1 | PS | Champix | VARENICLINE TARTRATE | 1 | Oral | 0.5 MG, 1X/DAY | Y | 610257531 FI | 21928 | .5 | MG | FILM-COATED TABLET | QD | ||||
| 73823004 | 7382300 | 2 | I | Champix | VARENICLINE TARTRATE | 1 | Oral | 0.5 MG, 2X/DAY | Y | 610257531 FI | 21928 | .5 | MG | FILM-COATED TABLET | BID | ||||
| 73823004 | 7382300 | 3 | I | Champix | VARENICLINE TARTRATE | 1 | Oral | 1 MG, 2X/DAY | Y | 610257531 FI | 21928 | 1 | MG | FILM-COATED TABLET | BID | ||||
| 73823004 | 7382300 | 4 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 19839 | |||||||||||
| 73823004 | 7382300 | 5 | I | AMOXICILLIN TRIHYDRATE | AMOXICILLIN | 1 | Oral | UNK | Y | 0 | TABLET | ||||||||
| 73823004 | 7382300 | 6 | I | AMOXICILLIN TRIHYDRATE | AMOXICILLIN | 1 | Y | 0 | TABLET | ||||||||||
| 73823004 | 7382300 | 7 | I | RINEXIN | PHENYLPROPANOLAMINE | 1 | Oral | 100 MG, UNK | Y | 0 | 100 | MG | |||||||
| 73823004 | 7382300 | 8 | SS | NICORETTE | NICOTINE | 1 | 4 MG, UNK | Y | 0 | 4 | MG | ||||||||
| 73823004 | 7382300 | 9 | SS | NICORETTE | NICOTINE | 1 | 2 UNK, UNK | Y | 0 | 2 | MG | ||||||||
| 73823004 | 7382300 | 10 | SS | NICORETTE | NICOTINE | 1 | UNK | U | 0 | ||||||||||
| 73823004 | 7382300 | 11 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 50MG, 1/2 TABLET DAILY | Y | 0 | QD | |||||||||
| 73823004 | 7382300 | 12 | SS | CIPRALEX | ESCITALOPRAM OXALATE | 1 | UNK | Y | 0 | ||||||||||
| 73823004 | 7382300 | 13 | SS | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | U | 0 | |||||||||||
| 73823004 | 7382300 | 14 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Oral | 3 | 0 | ||||||||||
| 73823004 | 7382300 | 15 | C | DOXIMYCIN | DOXYCYCLINE | 1 | Oral | UNK | 0 | ||||||||||
| 73823004 | 7382300 | 16 | C | KLACID | CLARITHROMYCIN | 1 | Oral | TEN DAYS COURSE | 0 | ||||||||||
| 73823004 | 7382300 | 17 | C | HAVRIX | HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | 1 | Intramuscular | UNK | 0 | ||||||||||
| 73823004 | 7382300 | 18 | C | TOCLASE | PENTOXYVERINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 73823004 | 7382300 | 1 | Nicotine dependence |
| 73823004 | 7382300 | 5 | Sinusitis |
| 73823004 | 7382300 | 6 | Influenza |
| 73823004 | 7382300 | 8 | Smoking cessation therapy |
| 73823004 | 7382300 | 14 | Influenza |
| 73823004 | 7382300 | 15 | Oropharyngeal pain |
| 73823004 | 7382300 | 16 | Acute sinusitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 73823004 | 7382300 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 73823004 | 7382300 | Abdominal discomfort | |
| 73823004 | 7382300 | Activities of daily living impaired | |
| 73823004 | 7382300 | Acute sinusitis | |
| 73823004 | 7382300 | Adjustment disorder with mixed anxiety and depressed mood | |
| 73823004 | 7382300 | Adrenal insufficiency | |
| 73823004 | 7382300 | Aggression | |
| 73823004 | 7382300 | Agitation | |
| 73823004 | 7382300 | Akathisia | |
| 73823004 | 7382300 | Anxiety | |
| 73823004 | 7382300 | Blood cholesterol increased | |
| 73823004 | 7382300 | Blood glucose increased | |
| 73823004 | 7382300 | Confusional state | |
| 73823004 | 7382300 | Craniocerebral injury | |
| 73823004 | 7382300 | Depression | |
| 73823004 | 7382300 | Dizziness | |
| 73823004 | 7382300 | Drug dependence | |
| 73823004 | 7382300 | Drug interaction | |
| 73823004 | 7382300 | Dyskinesia | |
| 73823004 | 7382300 | Dyspnoea | |
| 73823004 | 7382300 | Erectile dysfunction | |
| 73823004 | 7382300 | Euphoric mood | |
| 73823004 | 7382300 | Fatigue | |
| 73823004 | 7382300 | Fear | |
| 73823004 | 7382300 | Feeling abnormal | |
| 73823004 | 7382300 | Feeling cold | |
| 73823004 | 7382300 | Gastric disorder | |
| 73823004 | 7382300 | Hallucination | |
| 73823004 | 7382300 | Hepatic steatosis | |
| 73823004 | 7382300 | Hyperhidrosis | |
| 73823004 | 7382300 | Hypersensitivity | |
| 73823004 | 7382300 | Hypopituitarism | |
| 73823004 | 7382300 | Hyporeflexia | |
| 73823004 | 7382300 | Hyposmia | |
| 73823004 | 7382300 | Hypothyroidism | |
| 73823004 | 7382300 | Increased appetite | |
| 73823004 | 7382300 | Infection | |
| 73823004 | 7382300 | Influenza | |
| 73823004 | 7382300 | Irritability | |
| 73823004 | 7382300 | Loss of libido | |
| 73823004 | 7382300 | Lower respiratory tract infection | |
| 73823004 | 7382300 | Memory impairment | |
| 73823004 | 7382300 | Mood swings | |
| 73823004 | 7382300 | Musculoskeletal discomfort | |
| 73823004 | 7382300 | Nausea | |
| 73823004 | 7382300 | Neurotoxicity | |
| 73823004 | 7382300 | Nightmare | |
| 73823004 | 7382300 | Obesity | |
| 73823004 | 7382300 | Olfacto genital dysplasia | |
| 73823004 | 7382300 | Palpitations | |
| 73823004 | 7382300 | Panic reaction | |
| 73823004 | 7382300 | Parkinson's disease | |
| 73823004 | 7382300 | Personality change | |
| 73823004 | 7382300 | Restlessness | |
| 73823004 | 7382300 | Secondary hypogonadism | |
| 73823004 | 7382300 | Sense of oppression | |
| 73823004 | 7382300 | Sleep disorder | |
| 73823004 | 7382300 | Snoring | |
| 73823004 | 7382300 | Somnolence | |
| 73823004 | 7382300 | Swelling | |
| 73823004 | 7382300 | Tinnitus | |
| 73823004 | 7382300 | Tremor | |
| 73823004 | 7382300 | Upper respiratory tract infection | |
| 73823004 | 7382300 | Vasodilatation | |
| 73823004 | 7382300 | Vertigo | |
| 73823004 | 7382300 | Weight increased | |
| 73823004 | 7382300 | 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 |
|---|---|---|---|---|---|---|
| 73823004 | 7382300 | 1 | 20070702 | 20070704 | 0 | |
| 73823004 | 7382300 | 2 | 20070705 | 20070708 | 0 | |
| 73823004 | 7382300 | 3 | 20070709 | 20071108 | 0 | |
| 73823004 | 7382300 | 5 | 20071105 | 20071108 | 0 | |
| 73823004 | 7382300 | 7 | 20071105 | 200711 | 0 | |
| 73823004 | 7382300 | 8 | 200603 | 2007 | 0 | |
| 73823004 | 7382300 | 10 | 200603 | 0 | ||
| 73823004 | 7382300 | 11 | 20090305 | 0 | ||
| 73823004 | 7382300 | 12 | 20071218 | 0 | ||
| 73823004 | 7382300 | 14 | 20071024 | 200710 | 0 | |
| 73823004 | 7382300 | 15 | 20071001 | 2007 | 0 | |
| 73823004 | 7382300 | 16 | 20071111 | 200711 | 0 | |
| 73823004 | 7382300 | 17 | 20070629 | 20070629 | 0 | |
| 73823004 | 7382300 | 18 | 20071001 | 0 |