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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

KALETRA: 208 Adverse Event Reports & Safety Profile

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208
Total FAERS Reports
29 (13.9%)
Deaths Reported
79
Hospitalizations
208
As Primary/Secondary Suspect
6
Life-Threatening
2
Disabilities

First Report: 19980223 · Latest Report: 201405

What Are the Most Common KALETRA Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
52 reports (25.0%)
#2 Most Reported
Exposure during pregnancy
20 reports (9.6%)
#3 Most Reported
Abortion spontaneous
19 reports (9.1%)

All KALETRA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 52 25.0% 14 13
Exposure during pregnancy 20 9.6% 0 2
Abortion spontaneous 19 9.1% 1 0
Premature baby 14 6.7% 6 4
Anaemia 11 5.3% 5 6
Kaposi's sarcoma 8 3.9% 0 0
Abortion induced 7 3.4% 3 0
Metabolic acidosis 7 3.4% 7 3
Coronary artery disease 6 2.9% 0 4
Death 6 2.9% 6 1
Drug interaction 6 2.9% 0 5
Hypotonia 6 2.9% 6 2
Status epilepticus 6 2.9% 0 6
Stillbirth 6 2.9% 1 0
Vomiting 6 2.9% 0 5
Blood cholesterol increased 5 2.4% 0 3
Caesarean section 5 2.4% 0 5
Cerebral infarction 5 2.4% 3 3
Hypotension 5 2.4% 4 3
Renal failure acute 5 2.4% 5 2

Who Reports KALETRA Side Effects? Age & Gender Data

Average age: 38.0 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is KALETRA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2001 1 0 1
2002 5 0 4
2003 4 0 0
2004 8 1 2
2005 4 1 0
2006 5 0 4
2007 3 1 2
2008 3 2 2
2009 3 0 0
2010 9 1 4
2011 8 1 4
2012 13 1 6
2013 56 6 26
2014 23 3 8

View full timeline →

What Is KALETRA Used For?

IndicationReports
Hiv infection 122
Maternal exposure timing unspecified 36
Antiretroviral therapy 19
Product used for unknown indication 13

KALETRA vs Alternatives: Which Is Safer?

KALETRA vs KANAMYCIN\KANAMYCIN A KALETRA vs KARDEGIC KALETRA vs KEPPRA KALETRA vs KETAMINE KALETRA vs KETOCONAZOLE KALETRA vs KETOPROFEN KALETRA vs KETOPROFEN LYSINE KALETRA vs KETOROLAC TROMETHAMINE KALETRA vs KETOROLAC\KETOROLAC TROMETHAMINE KALETRA vs KETOTIFEN

Official FDA Label for KALETRA

Official prescribing information from the FDA-approved drug label.