What the label lists and what reports show
Ibalizumab side effects
Ibalizumab's FDA label: “The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash.” FAERS holds 536 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is viral load increased (45 reports).
- No generic listed
Check it at the source: the ibalizumab FDA label on DailyMed (effective January 7, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TROGARZO?TROGARZO can cause serious side effects, including: Allergic reactions. TROGARZO can cause allergic reactions, including serious reactions, during and after IV infusion or IV push. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following symptoms of an allergic reaction: o trouble breathing o cough o swelling in your throat o hot flush o wheezing o nausea o chest pain o vomiting o chest tightness Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicine. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after receiving TROGARZO. […]
Source: FDA drug label, Theratechnologies Inc., effective January 7, 2026 (SPL set c548ad82-9d1f-4d16-95b6-4e6106badf43), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash.
Table 3. Adverse Reactions (All Grades) Reported in ≥ 5% of Subjects Receiving TROGARZO and Optimized Background Regimen for 23 Weeks in Trial TMB-301
| Reaction | % Subjects N=40 |
|---|---|
| Diarrhea | 8% |
| Dizziness | 8% |
| Nausea | 5% |
| Rash Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash… | 5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse drug reactions are discussed in other sections of the labeling: Immune Reconstitution Inflammatory Syndrome [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient support ® at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 350 subjects have been exposed to TROGARZO in the ibalizumab clinical development program, including 45 subjects who received TROGARZO through expanded access programs. A total of 19 subjects received TROGARZO via IV push. The safety profile of TROGARZO administered via IV push (Trial TMB-302) was similar to that seen with IV infusion administration (Trial TMB-301) [see Clinical Pharmacology ( 12.3 )]. Trial TMB-301 The primary safety assessment of TROGARZO is based on 24 weeks of data from Trial TMB-301. …
Source: FDA drug label, Theratechnologies Inc., effective January 7, 2026 (SPL set c548ad82-9d1f-4d16-95b6-4e6106badf43), via openFDA; the full label on DailyMed
What do FAERS reports show?
536 reports list ibalizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 38 are coded as a death and 118 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ibalizumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions