What the label lists and what reports show
Bexarotene side effects
Bexarotene's FDA label: “The most common adverse reactions (greater than 10%) include: hyperlipidemia, hypercholesteremia, headache, hypothyroidism, asthenia, leukopenia, rash, nausea, infection, peripheral edema, abdominal pain, and dry skin.” FAERS holds 1,309 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 hypothyroidism (75 reports).
- Generic listed
- Boxed warning
Check it at the source: the bexarotene FDA label on DailyMed (effective April 30, 2020, Bausch Health US, 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 TARGRETIN?TARGRETIN can cause serious side effects, including: • See “What is the most important information I should know about TARGRETIN?” • Increased levels of fats (lipids) called cholesterol or triglycerides, in your blood are common with TARGRETIN, but can also be serious. Your healthcare provider may prescribe you medicines to treat high cholesterol or triglycerides levels, reduce your dose, temporarily stop treatment or completely stop treatment with TARGRETIN if you have this problem. • Inflammation of the pancreas (acute pancreatitis). TARGRETIN can sometimes cause pancreatitis that comes on suddenly (acute), and that can lead to death. […]
Source: FDA drug label, Bausch Health US, LLC, effective April 30, 2020 (SPL set 1d056725-0576-4338-8089-6336e768ccdc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (greater than 10%) include: hyperlipidemia, hypercholesteremia, headache, hypothyroidism, asthenia, leukopenia, rash, nausea, infection, peripheral edema, abdominal pain, and dry skin.
Table 2: Adverse Events with Incidence ≥10% in CTCL Trials
| Reaction | 300 N=84 N (%) | >300 N=53 N (%) |
|---|---|---|
| Hyperlipemia | 66 (79) | 42 (79) |
| Hypercholesteremia | 27 (32) | 33 (62) |
| Lactic dehydrogenase increased | 6 (7) | 7 (13) |
| Headache | 25 (30) | 22 (42) |
| Asthenia | 17 (20) | 24 (45) |
| Infection | 11 (13) | 12 (23) |
| Abdominal pain | 9 (11) | 2 (4) |
| Chills | 8 (10) | 7 (13) |
| Fever | 4 (5) | 9 (17) |
| Flu syndrome | 3 (4) | 7 (13) |
| Back pain | 2 (2) | 6 (11) |
| Infection bacterial | 1 (1) | 7 (13) |
| Hypothyroidism | 24 (29) | 28 (53) |
| Rash | 14 (17) | 12 (23) |
| Dry skin | 9 (17) | 5 (9) |
| Exfoliative dermatitis | 8 (10) | 15 (28) |
| Alopecia | 3 (4) | 6 (11) |
| Leukopenia | 14 (17) | 25 (47) |
| Anemia | 5 (6) | 13 (25) |
| Hypochromic anemia | 3 (4) | 7 (13) |
| Nausea | 13 (16) | 4 (8) |
| Diarrhea | 6 (7) | 22 (42) |
| Vomiting | 3 (4) | 7 (13) |
| Anorexia | 2 (2) | 12 (23) |
| Peripheral edema | 11 (13) | 6 (11) |
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 serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Hyperlipidemia [ see Warnings and Precautions (5.1) ] • Pancreatitis [ see Warnings and Precautions (5.2) ] • Hepatotoxicity, Cholestasis, and Hepatic Failure [ see Warnings and Precautions (5.3) ] • Hypothyroidism [ see Warnings and Precautions (5.4) ] • Neutropenia [ see Warnings and Precautions (5.5) ] • Cataracts [ see Warnings and Precautions (5.6) ] • Vitamin A Supplementation Hazard [ see Warnings and Precautions (5.7) ] • Hypoglycemia Risk in Patients with Diabetes Mellitus [ see Warnings and Precautions (5.8) ] • Photosensitivity [ see Warnings and Precautions (5.9) ] • Laboratory Tests [ see Warnings and Precautions (5.10) ] • Drug/Laboratory Test Interactions [ see Warnings and Precautions (5.11) ] The most common adverse reactions (greater than 10%) include: hyperlipidemia, hypercholesteremia, headache, hypothyroidism, asthenia, leukopenia, rash, nausea, infection, peripheral edema, abdominal pain, and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Bausch Health US, LLC, effective April 30, 2020 (SPL set 1d056725-0576-4338-8089-6336e768ccdc), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,309 reports list bexarotene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 247 are coded as a death and 389 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 18 reactions below, 10 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?
- Bexarotene: 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