What the label lists and what reports show
Raltegravir side effects
Raltegravir's FDA label: “The most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue ( 6.1 ).” FAERS holds 16,416 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 depression (1,017 reports).
- Generic approved
Check it at the source: the raltegravir FDA label on DailyMed (effective October 18, 2024, Merck Sharp & Dohme LLC); 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 ISENTRESS or ISENTRESS HD?ISENTRESS and ISENTRESS HD can cause serious side effects including: Severe skin reactions and allergic reactions. Some people who take ISENTRESS or ISENTRESS HD develop severe skin reactions and allergic reactions that can be serious, and may be life-threatening or lead to death. If you develop a rash, call your doctor right away. If you develop a rash with any of the following symptoms, stop using ISENTRESS or ISENTRESS HD and call your doctor or get medical help right away: fever generally ill feeling extreme tiredness muscle or joint aches blisters or sores in mouth blisters or peeling of the skin redness or swelling of the eyes swelling of the mouth, lips, or face problems breathing Sometimes allergic reactions can affect body organs, such as your liver. […]
Source: FDA drug label, Merck Sharp & Dohme LLC, effective October 18, 2024 (SPL set 89a5ec53-d956-4329-8004-0f40f51c88a3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue ( 6.1 ).
Table 6: Adverse Reactions Includes adverse experiences considered by investigators to be at least possibly, probably, or definitely related to the drug. of Moderate to Severe Intensity Intensities are defined as…
| Reaction | ISENTRESS 400 mg Twice Daily (N= 281) | Efavirenz 600 mg At Bedtime (N= 282) | ISENTRESS HD 1200 mg Once Daily (N=531) | ISENTRESS 400 mg Twice Daily (N=266) |
|---|---|---|---|---|
| Headache | 4% | 5% | 1% | <1% |
| Insomnia | 4% | 4% | <1% | <1% |
| Nausea | 3% | 4% | 1% | 0% |
| Dizziness | 2% | 6% | <1% | 0% |
| Fatigue | 2% | 3% | 0% | 0% |
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, continuedBecause 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. The most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue ( 6.1 ). Creatine kinase elevations were observed in subjects who received ISENTRESS or ISENTRESS HD. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective October 18, 2024 (SPL set 89a5ec53-d956-4329-8004-0f40f51c88a3), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,416 reports list raltegravir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,634 are coded as a death and 5,029 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 17 reactions below, 5 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?
- Raltegravir: 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