ABACAVIR\LAMIVUDINE\ZIDOVUDINE: 393 Adverse Event Reports & Safety Profile

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393

Total FAERS Reports

20 (5.1%)

Deaths Reported

Hospitalizations

393

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: ABACAVIR SULFATE\LAMIVUDINE\ZIDOVUDINE ·

First Report: 2001 · Latest Report: 20240501

What Are the Most Common ABACAVIR\LAMIVUDINE\ZIDOVUDINE Side Effects?

#1 Most Reported

Virologic failure

57 reports (14.5%)

#2 Most Reported

Foetal exposure during pregnancy

40 reports (10.2%)

#3 Most Reported

Drug ineffective

39 reports (9.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Virologic failure	57	14.5%	6	7
Foetal exposure during pregnancy	40	10.2%	3	5
Drug ineffective	39	9.9%	1	6
Lipodystrophy acquired	29	7.4%	0	1
Treatment failure	29	7.4%	1	0
Viral mutation identified	29	7.4%	0	0
Sleep disorder	26	6.6%	0	0
Gastrointestinal disorder	22	5.6%	0	0
Multiple-drug resistance	22	5.6%	0	7
Pyrexia	20	5.1%	6	10
Pathogen resistance	19	4.8%	0	0
Anxiety	17	4.3%	1	1
Exposure during pregnancy	17	4.3%	1	1
Maternal exposure during pregnancy	16	4.1%	0	2
Hiv infection	15	3.8%	5	11
Treatment noncompliance	15	3.8%	0	2
Drug interaction	13	3.3%	1	5
Premature delivery	13	3.3%	0	11
Caesarean section	12	3.1%	0	10
Diarrhoea	12	3.1%	0	2

Gender: 41.6% female, 58.4% male. Average age: 46.5 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2001	2	0	0
2002	8	0	0
2003	4	0	1
2004	5	0	0
2005	6	5	4
2007	1	0	0
2008	2	0	2
2009	3	0	0
2010	21	0	12
2011	6	2	0
2012	3	0	0
2013	4	0	1
2014	19	0	10
2015	12	0	6
2016	3	0	0
2017	15	3	4
2018	11	1	6
2019	7	0	0
2021	3	0	3
2023	10	0	0
2024	3	0	3

Indication	Reports
Hiv infection	292
Product used for unknown indication	47
Antiretroviral therapy	6
Prophylaxis against hiv infection	6
Maternal exposure timing unspecified	5

Official prescribing information from the FDA-approved drug label.