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Raltegravir Side Effects

The most commonly reported side effects of raltegravir include drug interaction, depression, and foetal exposure during pregnancy, based on 18,122 FDA adverse event reports from 2004 to 2025.

Raltegravir side effects

Percentages show how often each reaction appears relative to total reports for raltegravir.

1
Drug Interaction7.8%1,420
2
Depression6.7%1,211
3
Foetal Exposure During Pregnancy6.4%1,163
4
Anxiety5.4%984
5
Pain5.0%899
6
Emotional Distress4.3%788
7
Maternal Exposure During Pregnancy4.3%786
8
Exposure During Pregnancy4.3%772
9
Anhedonia3.9%708
10
Virologic Failure3.5%630
11
Death3.2%576
12
Chronic Kidney Disease3.1%556
13
Renal Failure2.8%503
14
Fatigue2.7%487
15
Pathogen Resistance2.7%487

These are voluntary reports and do not establish that raltegravir caused these reactions.

Report severity

84.1%Serious15,240 reports
30.3%Hospitalizations5,490 reports
10.8%Fatal1,965 reports

Seriousness is determined by the reporter, not by OpenClaim.

Raltegravir drug interactions

Other drugs that appear in adverse event reports alongside raltegravir. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tenofovir30.8%5,588
2
Ritonavir25.8%4,678
3
Emtricitabine25.7%4,665
4
Lamivudine19.7%3,571
5
Darunavir17.4%3,152
6
Zidovudine10.6%1,924
7
Abacavir10.0%1,808
8
Efavirenz9.9%1,799
9
Etravirine8.7%1,575
10
Lopinavir8.5%1,542
11
Atazanavir-sulfate7.7%1,404
12
Dolutegravir5.3%956
13
Nevirapine4.5%822
14
Maraviroc3.5%643
15
Ribavirin2.9%523

Taken alongside

1
Tenofovir17.7%3,216
2
Emtricitabine17.3%3,132
3
Ritonavir13.2%2,385
4
Lamivudine10.0%1,808
5
Darunavir9.7%1,750
6
Abacavir6.4%1,156
7
Etravirine5.0%915
8
Sulfamethoxazole4.7%845
9
Zidovudine4.1%749
10
Trimethoprim3.9%714
11
Enfuvirtide3.9%710
12
Atazanavir-sulfate3.9%705
13
Lopinavir3.8%687
14
Aspirin3.7%663
15
Dolutegravir3.6%661

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports raltegravir side effects

29.2% of raltegravir adverse event reports involve female patients and 56.7% involve male patients. The largest age group is adult at 84%. These figures reflect who reports side effects, not underlying risk.

Sex

Female29.2%
Male56.7%
Unknown14.1%

Age group

< 25.8%
2–110.9%
12–171.1%
18–6484.4%
65+7.9%

What is raltegravir used for

Conditions and purposes for which patients were taking raltegravir when the adverse event was reported.

Abdominal PainAcquired Immunodeficiency SyndromeAcute Hiv InfectionAcute Kidney InjuryAcute Myeloid LeukaemiaAdult T-cell Lymphoma/leukaemiaAidsAnti-infective TherapyAntiretroviral TherapyAntiviral ProphylaxisAntiviral TreatmentAsymptomatic Hiv InfectionAutoimmune DisorderAcquired Immunodeficiency SyndromeAcute Hiv Infection

Showing 15 of 175 indications

Raltegravir brand names and reporting trend

Raltegravir is sold under the brand name Isentress.

Brand names

Isentress8,777

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking raltegravir with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.