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Ibalizumab Side Effects

The most commonly reported side effects of ibalizumab include viral load increased, rash, and product dose omission issue, based on 523 FDA adverse event reports from 2016 to 2025. 9.0% of reports found the drug to be ineffective.

Ibalizumab side effects

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

1
Drug Ineffective9.0%47
2
Viral Load Increased8.8%46
3
Rash8.0%42
4
Product Dose Omission Issue7.6%40
5
Hospitalisation6.3%33
6
Off Label Use6.1%32
7
Fatigue5.7%30
8
Diarrhoea5.4%28
9
Pruritus5.2%27
10
Death4.6%24
11
Nausea4.6%24
12
Dizziness3.8%20
13
Pain3.8%20
14
Virologic Failure3.6%19
15
Pyrexia3.3%17

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

Report severity

41.5%Serious217 reports
22.2%Hospitalizations116 reports
7.6%Fatal40 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ibalizumab drug interactions

Other drugs that appear in adverse event reports alongside ibalizumab. 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
Lenacapavir9.6%50
2
Tenofovir8.6%45
3
Emtricitabine8.0%42
4
Cabotegravir6.9%36
5
Rilpivirine6.7%35
6
Dolutegravir5.4%28
7
Lamivudine4.2%22
8
Fostemsavir-tromethamine3.4%18
9
Ritonavir2.9%15
10
Darunavir2.9%15
11
Enfuvirtide2.3%12
12
Foscarnet-sodium2.1%11
13
Bictegravir2.1%11
14
Maraviroc2.1%11
15
Doravirine1.7%9

Taken alongside

1
Dolutegravir13.6%71
2
Darunavir12.2%64
3
Tenofovir11.9%62
4
Emtricitabine11.5%60
5
Fostemsavir-tromethamine8.0%42
6
Lenacapavir6.5%34
7
Ritonavir6.3%33
8
Cobicistat6.3%33
9
Doravirine5.0%26
10
Sulfamethoxazole4.6%24
11
Trimethoprim4.6%24
12
Atorvastatin-calcium4.6%24
13
Sodium-chloride4.0%21
14
Valacyclovir-hydrochloride3.8%20
15
Rilpivirine3.8%20

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 ibalizumab side effects

11.7% of ibalizumab adverse event reports involve female patients and 37.3% involve male patients. The largest age group is adult at 91%. These figures reflect who reports side effects, not underlying risk.

Sex

Female11.7%
Male37.3%
Unknown51.1%

Age group

< 21.3%
2–110.0%
12–170.0%
18–6491.3%
65+7.4%

What is ibalizumab used for

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

Acquired Immunodeficiency SyndromeAcquired Immunodeficiency SyndromeAntiretroviral TherapyCongenital Hiv InfectionDermatitis AtopicDrug ResistanceDysphagiaHiv InfectionHiv InfectionHiv Test PositiveHiv ViraemiaHiv-2 InfectionMultiple-drug ResistancePathogen ResistanceProduct Used For Unknown Indication

Showing 15 of 18 indications

Ibalizumab brand names and reporting trend

Ibalizumab is sold under the brand name Trogarzo.

Brand names

Trogarzo84

Quarterly reports (20162025)

2016202020242025

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

Taking ibalizumab with another medication?

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