DIDANOSINE: 2,065 Adverse Event Reports & Safety Profile
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2,065
Total FAERS Reports
167 (8.1%)
Deaths Reported
357
Hospitalizations
2,065
As Primary/Secondary Suspect
94
Life-Threatening
37
Disabilities
Apr 8, 2010
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 020154 ·
First Report: 1990 · Latest Report: 20230526
What Are the Most Common DIDANOSINE Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
472 reports (22.9%)
#2 Most Reported
Lipodystrophy acquired
216 reports (10.5%)
#3 Most Reported
Eyelid ptosis
191 reports (9.2%)
All DIDANOSINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 472 | 22.9% | 75 | 116 |
| Lipodystrophy acquired | 216 | 10.5% | 1 | 5 |
| Eyelid ptosis | 191 | 9.3% | 0 | 4 |
| Drug resistance | 189 | 9.2% | 10 | 13 |
| Virologic failure | 187 | 9.1% | 9 | 14 |
| Mitochondrial toxicity | 174 | 8.4% | 2 | 3 |
| Viral mutation identified | 171 | 8.3% | 1 | 0 |
| Diplopia | 170 | 8.2% | 0 | 0 |
| Treatment failure | 170 | 8.2% | 17 | 2 |
| Pathogen resistance | 135 | 6.5% | 3 | 6 |
| Pregnancy | 123 | 6.0% | 6 | 32 |
| Blood lactic acid increased | 104 | 5.0% | 1 | 45 |
| Dysphagia | 97 | 4.7% | 0 | 4 |
| Premature baby | 96 | 4.7% | 7 | 33 |
| Maternal exposure during pregnancy | 88 | 4.3% | 1 | 18 |
| Drug-induced liver injury | 77 | 3.7% | 2 | 5 |
| Progressive external ophthalmoplegia | 76 | 3.7% | 0 | 0 |
| Ophthalmoplegia | 72 | 3.5% | 0 | 0 |
| Anaemia | 71 | 3.4% | 2 | 48 |
| Caesarean section | 66 | 3.2% | 5 | 21 |
Who Reports DIDANOSINE Side Effects? Age & Gender Data
Gender: 38.5% female, 61.5% male. Average age: 37.9 years. Most reports from: US. View detailed demographics →
Is DIDANOSINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 72 | 5 | 29 |
| 2001 | 75 | 4 | 27 |
| 2002 | 49 | 4 | 21 |
| 2003 | 36 | 2 | 12 |
| 2004 | 68 | 11 | 18 |
| 2005 | 43 | 6 | 20 |
| 2006 | 41 | 4 | 16 |
| 2007 | 15 | 0 | 9 |
| 2008 | 17 | 1 | 4 |
| 2009 | 19 | 0 | 1 |
| 2010 | 10 | 0 | 3 |
| 2011 | 24 | 0 | 1 |
| 2012 | 19 | 0 | 3 |
| 2013 | 16 | 1 | 4 |
| 2014 | 20 | 2 | 8 |
| 2015 | 34 | 0 | 10 |
| 2016 | 18 | 1 | 10 |
| 2017 | 2 | 0 | 0 |
| 2018 | 11 | 0 | 4 |
| 2019 | 3 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
| 2021 | 4 | 0 | 3 |
| 2022 | 1 | 0 | 0 |
| 2023 | 8 | 0 | 0 |
What Is DIDANOSINE Used For?
DIDANOSINE vs Alternatives: Which Is Safer?
DIDANOSINE vs DIENOGEST
DIDANOSINE vs DIENOGEST\ESTRADIOL
DIDANOSINE vs DIENOGEST\ETHINYL ESTRADIOL
DIDANOSINE vs DIETARY SUPPLEMENT
DIDANOSINE vs DIETARY SUPPLEMENT\HERBALS
DIDANOSINE vs DIETARY SUPPLEMENT\MINERALS\VITAMINS
DIDANOSINE vs DIETARY SUPPLEMENT\UBIDECARENONE
DIDANOSINE vs DIFELIKEFALIN
DIDANOSINE vs DIFLUNISAL
DIDANOSINE vs DIFLUPREDNATE
Official FDA Label for DIDANOSINE
Official prescribing information from the FDA-approved drug label.