What the label lists and what reports show
Maraviroc side effects
Maraviroc's FDA label: “The most common adverse events in treatment-experienced adult subjects (greater than 8% incidence) which occurred at a higher frequency compared with placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness.” FAERS holds 2,288 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 virologic failure (140 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the maraviroc FDA label on DailyMed (effective September 26, 2022, ViiV Healthcare Company); 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 SELZENTRY?SELZENTRY can cause serious side effects including: • See “What is the most important information I should know about SELZENTRY?” • Severe skin rash and allergic reactions. Severe and potentially life-threatening skin reactions and allergic reactions have been reported in some people taking SELZENTRY. If you develop a rash with any of the following symptoms, stop using SELZENTRY and contact your healthcare provider right away: • fever • generally ill feeling • muscle aches • blisters or sores in your mouth • blisters or peeling of the skin • redness or swelling of the eyes • swelling of the mouth or face or lips • problems breathing • yellowing of the skin or whites of your eyes • dark or tea-colored urine • pain, aching, or tenderness on the right side below the ribs • loss of appetite • nausea/vomiting • Heart problems including heart attack. […]
Source: FDA drug label, ViiV Healthcare Company, effective September 26, 2022 (SPL set 46f30ac5-c96b-429e-976d-8c5ee1c0761b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse events in treatment-experienced adult subjects (greater than 8% incidence) which occurred at a higher frequency compared with placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness.
Table 5. Selected Treatment-Emergent Adverse Events (All Causality) ≥2% on SELZENTRY (and at a Higher Rate Compared with Placebo) in Trials A4001027 and A4001028 (Pooled Analysis, 48 Weeks)
| Body System/ Adverse Event | (n = 426) % | Exposure-Adjusted Rate (per 100 pt-yrs) PYE = 309 b | (n = 209) % | Exposure-Adjusted Rate (per 100 pt-yrs) PYE = 111 b |
|---|---|---|---|---|
| Conjunctivitis | 2 | 3 | 1 | 3 |
| Ocular infections, inflammations, and associated manifestations | 2 | 3 | 1 | 2 |
| Constipation | 6 | 9 | 3 | 6 |
| Pyrexia | 13 | 20 | 9 | 17 |
| Pain and discomfort | 4 | 5 | 3 | 5 |
| Upper respiratory tract infection | 23 | 37 | 13 | 27 |
| Herpes infection | 8 | 11 | 4 | 8 |
| Sinusitis | 7 | 10 | 3 | 6 |
| Bronchitis | 7 | 9 | 5 | 9 |
| Folliculitis | 4 | 5 | 2 | 4 |
| Anogenital warts | 2 | 3 | 1 | 3 |
| Influenza | 2 | 3 | 0.5 | 1 |
| Otitis media | 2 | 3 | 0.5 | 1 |
| Appetite disorders | 8 | 11 | 7 | 13 |
| Joint-related signs and symptoms | 7 | 10 | 3 | 5 |
| Muscle pains | 3 | 4 | 0.5 | 1 |
| Skin neoplasms benign | 3 | 4 | 1 | 3 |
| Dizziness/postural dizziness | 9 | 13 | 8 | 17 |
| Paresthesias and dysesthesias | 5 | 7 | 3 | 6 |
| Sensory abnormalities | 4 | 6 | 1 | 3 |
| Disturbances in consciousness | 4 | 5 | 3 | 6 |
| Peripheral neuropathies | 4 | 5 | 3 | 6 |
| Disturbances in initiating and maintaining sleep | 8 | 11 | 5 | 10 |
| Depressive disorders | 4 | 6 | 3 | 5 |
| Anxiety symptoms | 4 | 5 | 3 | 7 |
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 reactions are discussed in other sections of the labeling: • Hepatotoxicity [see Boxed Warning, Warnings and Precautions ( 5.1 )] • Severe Skin and Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] • Cardiovascular Events [see Warnings and Precautions ( 5.3 )] • The most common adverse events in treatment-experienced adult subjects (greater than 8% incidence) which occurred at a higher frequency compared with placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness. ( 6.1 ) • The most common adverse events in treatment-naive adult subjects (greater than 8% incidence) which occurred at a higher frequency than the comparator arm are upper respiratory tract infections, bronchitis, flatulence, bloating and distention, upper respiratory tract signs and symptoms, and gastrointestinal atonic and hypomotility disorders. ( 6.1 ) • The most common adverse reactions in treatment-experienced pediatric subjects (greater than or equal to 3% incidence) are vomiting, abdominal pain, diarrhea, nausea, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, ViiV Healthcare Company, effective September 26, 2022 (SPL set 46f30ac5-c96b-429e-976d-8c5ee1c0761b), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,288 reports list maraviroc among the medicines taken, each a report of something that happened, not proof the medicine caused it; 264 are coded as a death and 824 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, 3 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?
- Maraviroc: 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