Drug Safety Information for KALETRA (Lopinavir; ritonavir)

Safety-related Labeling Changes for KALETRA (LOPINAVIR; RITONAVIR) Rx Drug: FDA Link

Adverse Drug Reactions for KALETRA* (Lopinavir; ritonavir)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with KALETRA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*649
2Nausea510
3Pyrexia510
4Drug interaction466
5Vomiting456
6Anaemia411
7Abortion spontaneous380
8Renal failure acute348
9Premature baby329
10Asthenia285
11Weight decreased281
12Headache262
13Renal failure255
14Abdominal pain242
15Fatigue226
16Immune reconstitution syndrome224
17Pregnancy212
18Rash210
19Dyspnoea209
20Death201

* This side effect also appears in "Top 10 Side Effects of KALETRA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking KALETRA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hiv infection23403
2Product used for unknown indication2114
3Maternal exposure during pregnancy1622
4Antiretroviral therapy1385
5Acquired immunodeficiency syndrome947
6Maternal exposure timing unspecified662
7Hiv test positive611
8Prophylaxis against hiv infection512
9Antiviral treatment423
10Prophylaxis230

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for KALETRA

Total Reports Filed with FDA: 41875


Number of FDA Adverse Event Reports by Patient Age for KALETRA

Total Reports Filed with FDA: 41875*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lopinavir; ritonavir (Kaletra)

Charts are based on 41875 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and KALETRA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.