Levacetylleucine: uses, dosing, side effects & brands
Levacetylleucine is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Powder
- Sold as
- Aqneursa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How levacetylleucine is dosed
From the FDA label for Aqneursa (application NDA219132). Other levacetylleucine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. ( 2.1 ) • Recommended dosage ( 2.2 ) Patient Body Weight Morning Dose Afternoon Dose Evening Dose 15 to <25 kg 1 g No Dose 1 g 25 to <35 kg 1 g 1 g 1 g 35 kg or more 2 g 1 g 1 g • See the full prescribing information for administration instructions. ( 2.3 ) 2.1 Important Recommendation Prior to AQNEURSA Treatment Initiation For females of reproductive potential, verify that the patient is not pregnant [see Use in Specific Populations ( 8.1 , 8.3 )]. 2.2 Recommended Dosage The recommended dosage of AQNEURSA is based on the patient’s actual body weight (kg) to be administered orally up to three times daily. See Table 1 . AQNEURSA can be taken with or without food [see Clinical Studies ( 14 )] . For 2 gram levacetylleucine doses, prepare two AQNEURSA packets individually [see Dosage and Administration ( 2.3 )] . Table 1 Recommended Dosage of Levacetylleucine Based on Body Weight (kg) Patient’s Body Weight Morning Dose Afternoon Dose Evening Dose 15 kg to less than 25 kg 1 gram No Dose 1 gram 25 kg to less than 35 kg 1 gram 1 gram 1 gram 35 kg or more 2 gram 1 gram 1 gram One AQNEURSA packet contains 1 gram levacetylleucine. Missed Dose If a dose of AQNEURSA is missed, skip the missed dose and take the next dose at the scheduled time. Do not take 2 doses at the same time…
Levacetylleucine side effects
Most common adverse reactions (incidence ≥5% and greater than placebo) are abdominal pain, dysphagia, upper respiratory tract infections, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact IntraBio Inc. at 1-833-306-9677 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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. The safety of AQNEURSA was evaluated in Trial 1, which included a total of 60 patients with Niemann-Pick disease Type C (NPC), in a placebo-controlled, randomized, crossover trial [see Clinical Studies ( 14 )] . The mean (SD) treatment duration of AQNEURSA was 86.2 (4.7) days (69 min, 97 max); the mean (SD) treatment duration on placebo was 87.3 (4.8) days (78 min, 113 max). Table 2 summarizes adverse reactions that occurred in patients who were treated with AQNEURSA in Treatment Period I of Trial 1. Table 2 Adverse Reactions that Occurred in Adult and Pediatric Patients with NPC at an Incidence of ≥5% in Treatment Period I of Trial 1 Adverse Reaction AQNEURSA N=30 n (%) Placebo N=30 n (%) Upper respiratory tract infection 5 (17) 1 (3) Abdominal pain 2 (7) 0 (0) Dysphagia 2 (7) 0 (0) Vomiting 2 (7) 0 (0)…
Who shouldn’t take levacetylleucine
None. None. ( 4 )
Levacetylleucine drug interactions
N-acetyl-DL-leucine or N-acetyl-D-leucine : Avoid concomitant use with AQNEURSA. ( 7.1 ) • P-glycoprotein (P-gp) Transporter Substrates : Monitor for adverse reactions if used with AQNEURSA. ( 7.2 ) 7.1 Effect of Other Drugs on AQNEURSA N-acetyl-DL-leucine and N-acetyl-D-leucine Avoid concomitant use of AQNEURSA with N-acetyl-DL-leucine and N-acetyl-D-leucine. The D-enantiomer, N-acetyl-D-leucine, competes with levacetylleucine for monocarboxylate transporter uptake, which may reduce the levacetylleucine efficacy. 7.2 Effect of AQNEURSA on Other Drugs P-glycoprotein (P-gp) Transporter Substrates Monitor more frequently for P-gp substrate related adverse reactions when used concomitantly with AQNEURSA. Levacetylleucine inhibits P-gp [see Clinical Pharmacology ( 12.3 )] . However, the clinical significance of this finding has not been fully characterized.
Every levacetylleucine product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Aqneursa.
What people report to the FDA about levacetylleucine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 23 reports naming levacetylleucine, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- interstitial lung disease4 reports
- dysphagia3 reports
- chest discomfort2 reports
- erythema2 reports
- hypersensitivity2 reports
- inappropriate schedule of product administration2 reports
- respiratory depression2 reports
- swollen tongue2 reports
Read these as a signal, not a rate. A report does not mean levacetylleucine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is levacetylleucine?
AQNEURSA (levacetylleucine) for oral suspension contains the drug substance levacetylleucine, a modified amino acid. Levacetylleucine is slightly soluble in aqueous solutions.
Can you take levacetylleucine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run levacetylleucine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does levacetylleucine come in?
Across the brands we track, levacetylleucine is currently marketed as powder, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic levacetylleucine?
We do not currently list a generic-labelled levacetylleucine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Levacetylleucine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/levacetylleucine
- MLA
- “Levacetylleucine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/levacetylleucine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for levacetylleucine on DailyMed (NIH) ↗.