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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is KALETRA Used For?
| Indication | Reports |
|---|---|
| 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.