Table 3.
Sex ratios of adverse drug event reports in VigiBase among 59 drugs with sex-biased ADRs
| WHO ATC category | Drug name/PK biasa | ADR bias | VB ratiob | ADR-VB relation |
|---|---|---|---|---|
| Alimentary tract, metabolism | Liraglutide | Females | 1.79 | Concordant |
| Ranitidine | Males | 1.52 | Discordant1 | |
| Rosiglitazone | Females | 0.79 | Discordant1 | |
| Blood and blood forming organ | Heparin | Females | 0.92 | Discordant2 |
| Aspirin | Females | 0.85 | Discordant2 | |
| Warfarin | Females | 0.91 | Discordant2 | |
| Clopidogrel | Females | 0.69 | Discordant2 | |
| Dabigatran | Females | 0.93 | Discordant2 | |
| Cardiovascular system | Torasemide | Females | 1.15 | Discordant2 |
| Pravastatin | Females | 1.13 | Discordant2 | |
| Amlodipine | Females | 1.41 | Concordant | |
| Digoxin | Females | 1.26 | Concordant | |
| Verapimil | Females | 1.56 | Concordant | |
| Aliskiren | Females | 1.27 | Concordant | |
| Losartan | Males | 1.41 | Discordant1 | |
| Propranolol | Females | 1.72 | Concordant | |
| Dofetilide | Females | 0.92 | Discordant2 | |
| Genito-urinary system, sex hormones | Mirabegron | Females | 1.95 | Concordant |
| Darifenacin | Females | 2.48 | Concordant | |
| Trospium | Females | 2.14 | Concordant | |
| Systemic hormonal preparations | Prednisone | Females | 1.17 | Discordant2 |
| Anti-infectives | Levofloxacin | Females | 1.26 | Concordant |
| Erythromycin | Females | 1.70 | Concordant | |
| Voriconazole | Females | 0.65 | Discordant1 | |
| Antineoplastics, immunomodulators | Cyclosporin | Neither | 1.25 | Discordant1 |
| Fluorouracil | Females | 1.00 | Discordant2 | |
| Paclitaxel | Females | 2.66 | Concordant | |
| Capecitabine | Females | 1.77 | Concordant | |
| Infliximab | Females | 1.51 | Concordant | |
| Adalimumab | Females | 2.02 | Concordant | |
| Anesthetics, analgesics | Morphine | Females | 1.57 | Concordant |
| Oxycodone | Females | 1.01 | Discordant2 | |
| Buprenorphine | Females | 1.61 | Concordant | |
| Tramadol | Females | 1.71 | Concordant | |
| Zolmitriptan | Females | 5.14 | Concordant | |
| Ketamine | Males | 1.07 | Discordant2 | |
| Anti-epileptics, anti-Parkinson’s | Carbamazepine | Females | 1.26 | Concordant |
| Gabapentin | Females | 1.84 | Concordant | |
| Perampanel | Females | 1.18 | Discordant2 | |
| Pramipexole | females | 1.19 | Discordant2 | |
| Psycholeptics | Olanzapine | Females | 0.92 | Discordant2 |
| Clozapine | Males | 0.61 | Concordant | |
| Risperidone | Females | 0.53 | Discordant1 | |
| Aripiprazol | Females | 1.27 | Concordant | |
| Diazepam | Females | 1.17 | Discordant2 | |
| Zolpidem | Females | 1.48 | Concordant | |
| Eszopiclone | Females | 1.85 | Concordant | |
| Psychoanaleptics | Imipramine | Females | 1.61 | Concordant |
| Nortriptyline | Females | 2.10 | Concordant | |
| Fluoxetine | Females | 2.29 | Concordant | |
| Citalopram | Females | 1.95 | Concordant | |
| Sertraline | Females | 2.00 | Concordant | |
| Bupropion | Females | 1.79 | Concordant | |
| Methylphenidate | Females | 0.47 | Discordant1 | |
| Antiparasitics | Primaquine | Females | 0.55 | Discordant1 |
| Respiratory | Terfenadine | Females | 1.66 | Concordant |
| Fexofenadine | Females | 2.05 | Concordant | |
| Miscellaneous | MDMA | females | 0.43 | Discordant1 |
| Cannabis | females | 0.51 | Discordant1 |
Threshold for designation of a VigiBase reporting sex bias was set at ± 20%
aFont style of drug name indicates direction of PK drug exposure bias: (normal: F > M; bold: M > F)
bFemale-to-male (F:M) ratio of suspected ADRs
1“false sex” error
2“false null” error