Butyrate

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.

• Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone Butyrate Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.ICD-10: L20.9

• None. None.contraindicated

Apply Hydrocortisone Butyrate Lotion for up to 2 weeks as a thin layer to the affected skin two times daily and rub in gently. Discontinue Hydrocortisone Butyrate Lotion when control is achieved. If no improvement is seen within 2 weeks, consider reassessment of the diagnosis. Before prescribing for more than 2 weeks, the additional benefits of extending treatment up to 4 weeks should be weighed against the risk of endocrine system adverse reactions and local adverse reactions [ see Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2) ]. Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or intravaginal use. Do not use Hydrocortisone Butyrate Lotion [ see Warnings and Precautions (5.1) ]: o With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. o On the face, underarms, or groin areas unless directed by a healthcare provider. Apply a thin layer to the affected skin two times daily. ( 2 ) Rub in gently. ( 2 ) Discontinue Hydrocortisone Butyrate Lotion when control is achieved. ( 2 ) Reassess diagnosis if no improvement is seen within 2 weeks. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse reactions.( 2 ) Avoid use under occlusion or in the diaper area. ( 2 ) Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or intravaginal use. ( 2 )

• Endocrine System Adverse Reactions: o Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if Hydrocortisone Butyrate Lotion is applied to large surface areas or used under occlusion. If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid. (5.1, 8.4) o Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. (5.1, 8.4) o Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios. (5.1, 8.4) • Ophthalmic Adverse Reactions: Topical corticosteroids, including Hydrocortisone Butyrate Lotion, may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.2) • Skin Infections: Initiate appropriate therapy if concomitant skin infections develop. (5.3) 5.1 Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA axis suppression [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5. 2)] • Skin infections [see Warnings and Precautions (5.3)] • Allergic contact dermatitis [see Warnings and Precautions (5.4)] The most common adverse reactions (> 1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact The J. Molner Company LLC at 1-800-552-8750 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2023 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect Hydrocortisone Butyrate Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age and 301 adult subjects with mild to moderate atopic dermatitis [see Clinical Studies (14)]. The incidence of selected adverse reactions reported by ≥1% of subjects during the studies is presented in Table 1 and Table 2 . TABLE 1.

8.1 Pregnancy Risk Summary There are no controlled or large-scale epidemiologic studies with Hydrocortisone Butyrate Lotion in pregnant women, and available data on hydrocortisone butyrate use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. In animal reproduction studies, when administered subcutaneously or topically to pregnant rats, rabbits, and mice, hydrocortisone butyrate induced adverse reproductive and developmental outcomes, including abortion, fetal death, malformation, delayed ossification, decrease in fetal weight, and delay in sexual maturation (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of hydrocortisone butyrate observed in animal studies and the systemic exposure that would be expected in humans after topical use of Hydrocortisone Butyrate Lotion. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits.

Metabolism

No studies were conducted to determine the pharmacokinetics of Hydrocortisone Butyrate Lotion. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

• Oct 29, 1982NDANDA018652Precision Dermat
• Sep 8, 1997NDANDA020769Precision Dermat
• Jan 14, 2004ANDAANDA076364Taro Pharm Inds
• Dec 27, 2004ANDAANDA076842Taro
• Aug 3, 2005ANDAANDA076654Taro Pharm Inds
• May 18, 2007NDANDA022076Bausch
• Nov 21, 2017ANDAANDA209556The J Molner
• Aug 17, 2018ANDAANDA210209Lupin

1. 1Off Label Use57331%
2. 2Drug Ineffective51928%
3. 3Infusion Related Reaction51328%
4. 4Rash50427%
5. 5Fatigue50327%
6. 6Glossodynia49727%
7. 7Systemic Lupus Erythematosus48726%
8. 8Hand Deformity48426%
9. 9Duodenal Ulcer Perforation48026%
10. 10Joint Swelling47226%
11. 11Rheumatoid Arthritis47226%
12. 12Swelling46425%
13. 13Hepatic Enzyme Increased46225%
14. 14Wound45925%
15. 15General Physical Health Deterioration45625%

Recent PubMed references pinned to Butyrate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The Influence of Bovine Colostrum and Sodium Butyrate Supplementation on Gut Microbiota and the Intestinal-Liver Axis in Weaned Piglets.
  Nutrients · 2026 · Pieszka M, Szczepanik K, Lepczyński A, et al.
  PMID 42280427DOI 10.3390/nu18111784
• Effects of Exogenous Selenium on Accumulations of Selenium, GABA and Antioxidant Activity of Chestnut During Germination.
  Molecules (Basel, Switzerland) · 2026 · Wang H, Liu W, Peng F, et al.
  PMID 42280150DOI 10.3390/molecules31111847
• Dual Roles of Voltage-gated Calcium Channels and γ-Aminobutyric Acid-mediated Signaling in Modulating Neurotensin Receptor Type 2-induced Antinociception.
  Anesthesiology · 2026 · Martin LF, Gomez K, Park J, et al.
  PMID 42262386DOI 10.1097/ALN.0000000000006077
• Comparative effects of sacubitril/valsartan versus enalapril on QRS duration and cardiac function in heart failure patients undergoing left bundle branch area pacing.
  Pakistan journal of pharmaceutical sciences · 2026 · Wang R, Hao C, Fang Z, et al.
  PMID 42262190DOI 10.36721/PJPS.2026.39.8.216.1
• Network functional connectivity and anterior cingulate cortex gamma-aminobutyric acid in antipsychotic medication-naïve first-episode psychosis patients.
  Psychological medicine · 2026 · Samson GD, Maximo JO, Nelson E, et al.
  PMID 42261240DOI 10.1017/S0033291726104358
• Baclofen Modulates Neural Intrinsic Functional Connectivity in Treatment-Seeking Individuals With Alcohol Use Disorder.
  Alcohol, clinical & experimental research · 2026 · Logge WB, Hurzeler TP, Haber PS, et al.
  PMID 42246466DOI 10.1111/acer.70332
• Sodium butyrate supplementation improves growth performance, gut health, hepatic enzyme activities, and disease resistance against Aeromonas hydrophila in Labeo rohita.
  Veterinary research communications · 2026 · Younas A, Fatima M, Shah SZH, et al.
  PMID 42240874DOI 10.1007/s11259-026-11307-z
• Butyrate blocks cell cycle progression in colorectal cancer organoids partially through HDAC2 inhibition.
  Frontiers in immunology · 2026 · Liu B, Huang Y, Wang X, et al.
  PMID 42238585DOI 10.3389/fimmu.2026.1788434

The 10 most recently updated of 1,859 ClinicalTrials.gov registrations naming Butyrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Human Experimental Models of Pain (HEMP)
  Not yet recruiting · Interventional · 25 enrolled · National Center for Complementary and Integrative Health (NCCIH)
  NCT07549490updated 2026-06-12
• Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL
  Active not recruiting · Phase 1 · Interventional · 43 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT03602157updated 2026-06-12
• WAKIX® (Pitolisant) Pregnancy Registry
  Recruiting · Observational · 1,329 enrolled · Harmony Biosciences Management, Inc.
  NCT05536011updated 2026-06-12
• Kynurenic Acid and Serotonin as Perioperative Neuroinflammatory Biomarkers in Sequential Third Molar Surgery
  Completed · Interventional · 40 enrolled · Plovdiv Medical University
  NCT07644065updated 2026-06-12
• Pregabalin Versus Placebo as an Add on for Complex Regional Pain Syndrome (CPRS) of the Upper Limb Managed by Stellate Ganglion Block (The PREGA Study)
  Terminated · Interventional · 14 enrolled · McMaster University
  NCT00891397updated 2026-06-11
• Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
  Recruiting · Phase 2 · Interventional · 213 enrolled · Miltenyi Biomedicine GmbH
  NCT04844866updated 2026-06-10
• Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
  Completed · Interventional · 101 enrolled · McMaster University
  NCT01307202updated 2026-06-10
• CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
  Recruiting · Phase 1 · Interventional · 25 enrolled · Mayo Clinic
  NCT04892277updated 2026-06-09
• Pharmacokinetics of Butyrate Tablet BKR-017
  Completed · Observational · 9 enrolled · BioKier Inc.
  NCT06556745updated 2026-06-09
• A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 960 enrolled · Merck Sharp & Dohme LLC
  NCT07634471updated 2026-06-08

Frequently asked questions

How does Butyrate work?

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.

What is Butyrate used for?

According to FDA labeling, Butyrate carries indications including: Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone Butyrate Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Butyrate?

Butyrate labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.