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Fostemsavir Side Effects

The most commonly reported side effects of fostemsavir include off label use, virologic failure, and pathogen resistance, based on 330 FDA adverse event reports from 2017 to 2025. 6.4% of reports found the drug to be ineffective.

Fostemsavir side effects

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

1
Off Label Use11.2%37
2
Virologic Failure10.3%34
3
Pathogen Resistance9.1%30
4
Drug Ineffective6.4%21
5
Viral Mutation Identified6.4%21
6
Death5.8%19
7
Nausea5.2%17
8
Viral Load Increased5.2%17
9
Treatment Noncompliance4.8%16
10
Drug Resistance4.2%14
11
Product Dose Omission Issue4.2%14
12
Blood Hiv Rna Increased3.9%13
13
Treatment Failure3.9%13
14
Condition Aggravated3.6%12
15
Rash3.3%11

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

Report severity

46.4%Serious153 reports
13.3%Hospitalizations44 reports
10.0%Fatal33 reports

Seriousness is determined by the reporter, not by OpenClaim.

Fostemsavir drug interactions

Other drugs that appear in adverse event reports alongside fostemsavir. 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
Dolutegravir21.5%71
2
Tenofovir18.8%62
3
Emtricitabine16.4%54
4
Lamivudine13.9%46
5
Ibalizumab-uiyk12.4%41
6
Ritonavir8.8%29
7
Lenacapavir8.8%29
8
Maraviroc7.6%25
9
Darunavir5.5%18
10
Etravirine4.8%16
11
Bictegravir4.8%16
12
Abacavir4.2%14
13
Zidovudine3.9%13
14
Rilpivirine3.9%13
15
Doravirine3.9%13

Taken alongside

1
Dolutegravir17.3%57
2
Emtricitabine14.5%48
3
Tenofovir13.9%46
4
Darunavir13.6%45
5
Doravirine7.3%24
6
Cobicistat7.0%23
7
Bictegravir6.1%20
8
Ibalizumab-uiyk5.8%19
9
Ritonavir5.2%17
10
Amlodipine4.8%16
11
Aspirin4.5%15
12
Sulfamethoxazole4.2%14
13
Lisinopril4.2%14
14
Etravirine3.9%13
15
Acyclovir3.6%12

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 fostemsavir side effects

15.2% of fostemsavir adverse event reports involve female patients and 50.0% involve male patients. The largest age group is adult at 78%. These figures reflect who reports side effects, not underlying risk.

Sex

Female15.2%
Male50.0%
Unknown34.8%

Age group

< 22.2%
2–110.0%
12–170.0%
18–6478.4%
65+19.4%

What is fostemsavir used for

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

Acquired Immunodeficiency SyndromeAntiretroviral TherapyAntiviral TreatmentCd4 LymphocytesCd4 Lymphocytes AbnormalCd4 Lymphocytes DecreasedCd4 Lymphocytes IncreasedDrug ResistanceHiv InfectionHiv InfectionHiv Infection Cdc Group IiiImmunology Test AbnormalProduct Used For Unknown IndicationProduct Used For Unknown IndicationViral Load Abnormal

Fostemsavir brand names and reporting trend

Fostemsavir is sold under the brand name Rukobia.

Brand names

Rukobia120

Quarterly reports (20172025)

20182020202220242025

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

Taking fostemsavir with another medication?

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