NEREUS 85 mg/1
TRADIPITANT · CAPSULE · Vanda Pharmaceuticals Inc.
NEREUS is a capsule containing tradipitant at 85 mg/1, taken oral. Manufactured by Vanda Pharmaceuticals Inc..
Key Facts
- Brand Name
- NEREUS
- Generic Name
- TRADIPITANT
- NDC Code (Product)
43068-585- Manufacturer
- Vanda Pharmaceuticals Inc.
- Strength
- 85 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA220152
- Marketing Start
- 03/31/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NEREUS is indicated for the prevention of vomiting induced by motion in adults. NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of NEREUS is 85 mg or 170 mg as a single oral dose approximately 60 minutes before an event expected to cause vomiting induced by motion. The safety of NEREUS for the prevention of vomiting induced by motion in adults for more than 90 doses has not been established in clinical trials. ( 2.1 ) The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. ( 2.1 ) Administer on an empty stomach, at least 1 hour prior to or 2 hours after a full meal. ( 2.1 ) 2.1 Recommended Dosage and Administration The recommended dosage of NEREUS is 85 mg or 170 mg as a single oral dose. Use the lowest effective dose. The safety of NEREUS for the prevention of vomiting induced by motion in adults for more than 90 doses has not been established in clinical trials [see Adverse Reactions (6.1) ] . Administer NEREUS orally approximately 60 minutes before an event expected to cause vomiting induced by motion. The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. Administer NEREUS on an empty stomach, at least 1 hour prior to or 2 hours after a full meal [see Clinical Pharmacology (12.3) ] .
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: May increase tradipitant exposure and the risk of adverse reactions. ( 7.1 ) 7.1 Effects of Other Drugs on NEREUS Strong CYP3A4 Inhibitors Tradipitant is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase tradipitant exposure, which may increase the risk of adverse reactions to NEREUS.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are: somnolence, headache, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) 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 a single 85 mg or 170 mg dose of NEREUS was evaluated in adult subjects with a history of motion sickness in two randomized, double-blind, placebo-controlled trials, Study 1 and Study 2 [see Clinical Studies (14) ] . Additional safety data for the 170 mg dose of NEREUS were obtained from a randomized, double-blind, placebo-controlled trial, Study 3 (NCT03772340). Adverse reactions reported in at least 5% of subjects treated with a single NEREUS 85 mg or 170 mg dose and at a higher frequency than subjects who received placebo, are shown in Table 1 . Table 1: Adverse Reactions a in Adult Subjects with a History …
Frequently Asked Questions
What is NEREUS used for?
NEREUS contains TRADIPITANT. It is a capsule taken oral. Consult your doctor for specific uses.
Is NEREUS a controlled substance?
NEREUS is not classified as a controlled substance by the DEA.
What is the generic name for NEREUS?
The generic name for NEREUS is TRADIPITANT. There are no other listed brand versions of TRADIPITANT.
What is the NDC code for NEREUS 85 mg/1?
The NDC (National Drug Code) for NEREUS 85 mg/1 is 43068-585, listed by Vanda Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)