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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115085626 | 11508562 | 6 | F | 20140830 | 20160923 | 20150915 | 20160930 | EXP | US-ASTRAZENECA-2014SE67433 | ASTRAZENECA | 26291.00 | DY | F | Y | 46.30000 | KG | 20160930 | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115085626 | 11508562 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | DOSE: UNKNOWN, FREQUENCY: UNKNOWN UNKNOWN | U | U | 21929 | ||||||||
| 115085626 | 11508562 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | DOSE: UNKNOWN, FREQUENCY: UNKNOWN UNKNOWN | U | U | 21929 | ||||||||
| 115085626 | 11508562 | 3 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | DOSE: UNKNOWN, FREQUENCY: UNKNOWN UNKNOWN | U | U | 21929 | ||||||||
| 115085626 | 11508562 | 4 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | DOSE: UNKNOWN, FREQUENCY: UNKNOWN UNKNOWN | U | U | 21929 | ||||||||
| 115085626 | 11508562 | 5 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160-4.5 MCG, ONE PUFF 3 TIMES A DAY(ONE PUFF IN THE MORNING, LATE AFTERNOON AND BEFORE BED. UNK... | U | U | 21929 | TID | |||||||
| 115085626 | 11508562 | 6 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160-4.5 MCG, ONE PUFF 3 TIMES A DAY(ONE PUFF IN THE MORNING, LATE AFTERNOON AND BEFORE BED. UNK... | U | U | 21929 | TID | |||||||
| 115085626 | 11508562 | 7 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160-4.5 MCG, ONE PUFF 3 TIMES A DAY(ONE PUFF IN THE MORNING, LATE AFTERNOON AND BEFORE BED. UNK... | U | U | 21929 | TID | |||||||
| 115085626 | 11508562 | 8 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160-4.5 MCG, ONE PUFF 3 TIMES A DAY(ONE PUFF IN THE MORNING, LATE AFTERNOON AND BEFORE BED. UNK... | U | U | 21929 | TID | |||||||
| 115085626 | 11508562 | 9 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS, TWO TIMES A DAY UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 10 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS, TWO TIMES A DAY UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 11 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS, TWO TIMES A DAY UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 12 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS, TWO TIMES A DAY UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 13 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS IN THE MORNING AND TWO PUFFS UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 14 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS IN THE MORNING AND TWO PUFFS UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 15 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS IN THE MORNING AND TWO PUFFS UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 16 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS IN THE MORNING AND TWO PUFFS UNKNOWN | U | U | 21929 | BID | |||||||
| 115085626 | 11508562 | 17 | SS | SYMLIN | PRAMLINTIDE ACETATE | 1 | Subcutaneous | 0 | INJECTION | ||||||||||
| 115085626 | 11508562 | 18 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 20 | MG | TID | ||||||||
| 115085626 | 11508562 | 19 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 20 | MG | TID | ||||||||
| 115085626 | 11508562 | 20 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0 | 5 | MG | TID | ||||||||
| 115085626 | 11508562 | 21 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0 | 5 | MG | TID | ||||||||
| 115085626 | 11508562 | 22 | C | PROVENTIL | ALBUTEROL | 1 | Respiratory (inhalation) | PRN | 0 | ||||||||||
| 115085626 | 11508562 | 23 | C | THEOPHYLLINE | THEOPHYLLINE ANHYDROUS | 1 | Oral | 0 | 400 | MG | BID | ||||||||
| 115085626 | 11508562 | 24 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 0 | |||||||||||
| 115085626 | 11508562 | 25 | C | POTASSIUM | POTASSIUM | 1 | 0 | ||||||||||||
| 115085626 | 11508562 | 26 | C | POLYETHYLENE GLYCOL POWDER | 2 | 0 | |||||||||||||
| 115085626 | 11508562 | 27 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 115085626 | 11508562 | 28 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | ||||||||||||
| 115085626 | 11508562 | 29 | C | POTASSIUM | POTASSIUM | 1 | 20 , UNKNOWN | 0 | |||||||||||
| 115085626 | 11508562 | 30 | C | POTASSIUM | POTASSIUM | 1 | 20 , UNKNOWN | 0 | |||||||||||
| 115085626 | 11508562 | 31 | C | FLUOXETINE HCL | FLUOXETINE HYDROCHLORIDE | 1 | 0 | 10 | MG | QD | |||||||||
| 115085626 | 11508562 | 32 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0 | .5 | MG | TID | |||||||||
| 115085626 | 11508562 | 33 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 10 325, EVERY 4 HOURS | 0 | |||||||||||
| 115085626 | 11508562 | 34 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | 100 | MG | QD | |||||||||
| 115085626 | 11508562 | 35 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | 100 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115085626 | 11508562 | 1 | Chronic obstructive pulmonary disease |
| 115085626 | 11508562 | 2 | Asthma |
| 115085626 | 11508562 | 3 | Bronchitis |
| 115085626 | 11508562 | 4 | Emphysema |
| 115085626 | 11508562 | 5 | Chronic obstructive pulmonary disease |
| 115085626 | 11508562 | 6 | Asthma |
| 115085626 | 11508562 | 7 | Bronchitis |
| 115085626 | 11508562 | 8 | Emphysema |
| 115085626 | 11508562 | 9 | Chronic obstructive pulmonary disease |
| 115085626 | 11508562 | 10 | Asthma |
| 115085626 | 11508562 | 11 | Bronchitis |
| 115085626 | 11508562 | 12 | Emphysema |
| 115085626 | 11508562 | 13 | Chronic obstructive pulmonary disease |
| 115085626 | 11508562 | 14 | Asthma |
| 115085626 | 11508562 | 15 | Bronchitis |
| 115085626 | 11508562 | 16 | Emphysema |
| 115085626 | 11508562 | 18 | Bone disorder |
| 115085626 | 11508562 | 19 | Sleep disorder therapy |
| 115085626 | 11508562 | 20 | Affective disorder |
| 115085626 | 11508562 | 21 | Accident at work |
| 115085626 | 11508562 | 22 | Lung disorder |
| 115085626 | 11508562 | 23 | Lung disorder |
| 115085626 | 11508562 | 24 | Accident at work |
| 115085626 | 11508562 | 29 | Bladder disorder |
| 115085626 | 11508562 | 30 | Renal disorder |
| 115085626 | 11508562 | 31 | Depression |
| 115085626 | 11508562 | 32 | Depression |
| 115085626 | 11508562 | 33 | Pain |
| 115085626 | 11508562 | 34 | Insomnia |
| 115085626 | 11508562 | 35 | Feeling of relaxation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115085626 | 11508562 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115085626 | 11508562 | Abnormal behaviour | |
| 115085626 | 11508562 | Body height decreased | |
| 115085626 | 11508562 | Cystitis | |
| 115085626 | 11508562 | Dehydration | |
| 115085626 | 11508562 | Dizziness | |
| 115085626 | 11508562 | Drug dose omission | |
| 115085626 | 11508562 | Dyspnoea | |
| 115085626 | 11508562 | Fall | |
| 115085626 | 11508562 | Fatigue | |
| 115085626 | 11508562 | Kidney infection | |
| 115085626 | 11508562 | Lung disorder | |
| 115085626 | 11508562 | Memory impairment | |
| 115085626 | 11508562 | Off label use | |
| 115085626 | 11508562 | Peripheral swelling | |
| 115085626 | 11508562 | Pneumonia | |
| 115085626 | 11508562 | Pneumonitis | |
| 115085626 | 11508562 | Sinusitis | |
| 115085626 | 11508562 | Weight decreased | |
| 115085626 | 11508562 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 115085626 | 11508562 | 9 | 2013 | 0 | ||
| 115085626 | 11508562 | 10 | 2013 | 0 | ||
| 115085626 | 11508562 | 11 | 2013 | 0 | ||
| 115085626 | 11508562 | 12 | 2013 | 0 | ||
| 115085626 | 11508562 | 13 | 20160912 | 0 | ||
| 115085626 | 11508562 | 14 | 20160912 | 0 | ||
| 115085626 | 11508562 | 15 | 20160912 | 0 | ||
| 115085626 | 11508562 | 16 | 20160912 | 0 | ||
| 115085626 | 11508562 | 22 | 2010 | 0 | ||
| 115085626 | 11508562 | 23 | 2011 | 0 |