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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126478361 | 12647836 | 1 | I | 20041128 | 20160725 | 20160812 | 20160812 | EXP | US-MYLANLABS-2016M1031510 | MYLAN | 0.00 | Y | 0.00000 | 20160812 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126478361 | 12647836 | 1 | PS | Levothyroxine Sodium Tablets, USP | LEVOTHYROXINE SODIUM | 1 | 125 ?G, QD | N | Y | 76187 | 125 | UG | TABLET | QD | |||||
| 126478361 | 12647836 | 2 | SS | Levothyroxine Sodium Tablets, USP | LEVOTHYROXINE SODIUM | 1 | 112 ?G, QD | N | Y | 76187 | 112 | UG | TABLET | QD | |||||
| 126478361 | 12647836 | 3 | SS | Levothyroxine Sodium Tablets, USP | LEVOTHYROXINE SODIUM | 1 | 100 ?G, UNK | N | Y | 76187 | 100 | UG | TABLET | QD | |||||
| 126478361 | 12647836 | 4 | SS | LEVOTHROID | LEVOTHYROXINE SODIUM | 1 | 125 ?G, UNK | N | Y | 0 | 125 | UG | TABLET | ||||||
| 126478361 | 12647836 | 5 | SS | LEVOTHROID | LEVOTHYROXINE SODIUM | 1 | 112 ?G, UNK | N | Y | 0 | 112 | UG | TABLET | ||||||
| 126478361 | 12647836 | 6 | SS | LEVOTHROID | LEVOTHYROXINE SODIUM | 1 | 100 ?G, UNK | N | Y | 0 | 100 | UG | TABLET | ||||||
| 126478361 | 12647836 | 7 | SS | AVANDAMET | METFORMIN HYDROCHLORIDEROSIGLITAZONE MALEATE | 1 | UNK | N | U | 0 | |||||||||
| 126478361 | 12647836 | 8 | SS | AVANDIA | ROSIGLITAZONE MALEATE | 1 | UNK | N | N | 0 | |||||||||
| 126478361 | 12647836 | 9 | SS | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | UNK | U | UNK | 0 | |||||||||
| 126478361 | 12647836 | 10 | SS | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Oral | UNK | N | U | 0 | ||||||||
| 126478361 | 12647836 | 11 | SS | GLUCOPHAGE LA | METFORMIN HYDROCHLORIDE | 1 | 1000 MG, BID | U | UNK | 0 | 1000 | MG | BID | ||||||
| 126478361 | 12647836 | 12 | SS | LEVEMIR | INSULIN DETEMIR | 1 | UNK | 0 | |||||||||||
| 126478361 | 12647836 | 13 | SS | NOVOLOG | INSULIN ASPART | 1 | UNK | 0 | |||||||||||
| 126478361 | 12647836 | 14 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 15 | C | MECLIZINE | MECLIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 17 | C | LASIX | FUROSEMIDE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 18 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 19 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 20 | C | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 21 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 22 | C | CLONIDINE. | CLONIDINE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 23 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 24 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 25 | C | AMOXICILLIN. | AMOXICILLIN | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 26 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 27 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 28 | C | DIOVAN | VALSARTAN | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 29 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | ||||||||||
| 126478361 | 12647836 | 30 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126478361 | 12647836 | 31 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126478361 | 12647836 | 1 | Autoimmune thyroiditis |
| 126478361 | 12647836 | 2 | Goitre |
| 126478361 | 12647836 | 4 | Autoimmune thyroiditis |
| 126478361 | 12647836 | 5 | Goitre |
| 126478361 | 12647836 | 7 | Diabetes mellitus |
| 126478361 | 12647836 | 8 | Diabetes mellitus |
| 126478361 | 12647836 | 11 | Type 2 diabetes mellitus |
| 126478361 | 12647836 | 12 | Type 2 diabetes mellitus |
| 126478361 | 12647836 | 13 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126478361 | 12647836 | OT |
| 126478361 | 12647836 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126478361 | 12647836 | Acute pulmonary oedema | |
| 126478361 | 12647836 | Anxiety | |
| 126478361 | 12647836 | Asthenia | |
| 126478361 | 12647836 | Back pain | |
| 126478361 | 12647836 | Blood glucose fluctuation | |
| 126478361 | 12647836 | Blood glucose increased | |
| 126478361 | 12647836 | Bronchitis | |
| 126478361 | 12647836 | Cardiac failure congestive | |
| 126478361 | 12647836 | Cellulitis | |
| 126478361 | 12647836 | Chest discomfort | |
| 126478361 | 12647836 | Chest pain | |
| 126478361 | 12647836 | Cough | |
| 126478361 | 12647836 | Dehydration | |
| 126478361 | 12647836 | Depression | |
| 126478361 | 12647836 | Diabetes mellitus inadequate control | |
| 126478361 | 12647836 | Diabetic neuropathy | |
| 126478361 | 12647836 | Diabetic retinopathy | |
| 126478361 | 12647836 | Disturbance in attention | |
| 126478361 | 12647836 | Drug dose omission | |
| 126478361 | 12647836 | Dyspnoea | |
| 126478361 | 12647836 | Erythema | |
| 126478361 | 12647836 | Fatigue | |
| 126478361 | 12647836 | Foot operation | |
| 126478361 | 12647836 | Hypersensitivity | |
| 126478361 | 12647836 | Hypertension | |
| 126478361 | 12647836 | Hypoaesthesia | |
| 126478361 | 12647836 | Hypoglycaemia | |
| 126478361 | 12647836 | Infection | |
| 126478361 | 12647836 | Intervertebral disc degeneration | |
| 126478361 | 12647836 | Joint swelling | |
| 126478361 | 12647836 | Local swelling | |
| 126478361 | 12647836 | Muscle spasms | |
| 126478361 | 12647836 | Myocardial ischaemia | |
| 126478361 | 12647836 | Nasal congestion | |
| 126478361 | 12647836 | Oedema mucosal | |
| 126478361 | 12647836 | Oxygen supplementation | |
| 126478361 | 12647836 | Pain | |
| 126478361 | 12647836 | Pain in extremity | |
| 126478361 | 12647836 | Palpitations | |
| 126478361 | 12647836 | Paranoia | |
| 126478361 | 12647836 | Peripheral swelling | |
| 126478361 | 12647836 | Pharyngeal erythema | |
| 126478361 | 12647836 | Pneumonia | |
| 126478361 | 12647836 | Pruritus | |
| 126478361 | 12647836 | Pyrexia | |
| 126478361 | 12647836 | Rash | |
| 126478361 | 12647836 | Rash erythematous | |
| 126478361 | 12647836 | Rash papular | |
| 126478361 | 12647836 | Rash pruritic | |
| 126478361 | 12647836 | Reaction to drug excipients | |
| 126478361 | 12647836 | Renal failure | |
| 126478361 | 12647836 | Respiratory disorder | |
| 126478361 | 12647836 | Rhinitis allergic | |
| 126478361 | 12647836 | Rhinorrhoea | |
| 126478361 | 12647836 | Skin lesion | |
| 126478361 | 12647836 | Skin ulcer | |
| 126478361 | 12647836 | Tonsillar disorder | |
| 126478361 | 12647836 | Type 2 diabetes mellitus | |
| 126478361 | 12647836 | Visual acuity reduced | |
| 126478361 | 12647836 | Weight increased | |
| 126478361 | 12647836 | Wheezing | |
| 126478361 | 12647836 | Wound | |
| 126478361 | 12647836 | Wound infection |
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 |
|---|---|---|---|---|---|---|
| 126478361 | 12647836 | 8 | 1992 | 0 | ||
| 126478361 | 12647836 | 10 | 20141015 | 20160217 | 0 | |
| 126478361 | 12647836 | 14 | 20141007 | 0 | ||
| 126478361 | 12647836 | 15 | 20141007 | 0 | ||
| 126478361 | 12647836 | 16 | 20150204 | 0 | ||
| 126478361 | 12647836 | 17 | 20141007 | 0 | ||
| 126478361 | 12647836 | 18 | 20140804 | 0 | ||
| 126478361 | 12647836 | 19 | 20150804 | 0 | ||
| 126478361 | 12647836 | 20 | 20151121 | 0 | ||
| 126478361 | 12647836 | 21 | 20160128 | 0 | ||
| 126478361 | 12647836 | 22 | 20141007 | 20160217 | 0 | |
| 126478361 | 12647836 | 23 | 20141104 | 20160217 | 0 | |
| 126478361 | 12647836 | 24 | 20150804 | 20160217 | 0 | |
| 126478361 | 12647836 | 25 | 20151201 | 20160217 | 0 |