Last reviewed 2026-04-20 · How we verify

Hycodan (METHYLHOMATROPINE)

Hycodan works by affecting the nervous system to reduce cough and relieve symptoms of irritable bowel syndrome and peptic ulcer.

At a glance

Mechanism of action

HydrocodoneHydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration.HomatropineHomatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

Approved indications

• Cough
• Irritable bowel syndrome
• Peptic ulcer

Boxed warnings

• WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME WARNING: ADDICTION, ABUSE, AND MISUSE;LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME See full prescribing information for complete boxed warning. HYCODAN exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor closely for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. ( 5.2 ) Accidental ingestion of HYCODAN, especially by children, can result in a fatal overdose of hydrocodone. ( 5.2 ) Ensure accuracy when prescribing, dispensing, and administering HYCODAN. Dosing errors can result in accidental overdose and death. ( 2.1 , 5.5 ) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone. Avoid the use of HYCODAN in patients taking CYP3A4 inhibitors or inducers. ( 5.7 , 7.2 , 7.3 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of HYCODAN in patients taking benzodiazepines, other CNS depressants, or alcohol. ( 5.8 , 7.4 ) Instruct patients not to consume alcohol or any products containing alcohol while taking HYCODAN because co-ingestion can result in fatal plasma hydrocodone levels. ( 5.8 , 7.1 ) HYCODAN is not recommended for use in pregnant women. Prolonged use of HYCODAN during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If HYCODAN is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ( 5.13 , 8.1 ) Addiction, Abuse, and Misuse HYCODAN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve HYCODAN for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient's risk prior to prescribing HYCODAN, prescribe HYCODAN for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of HYCODAN. Monitor for respiratory depression, especially during initiation of HYCODAN therapy or when used in patients at higher risk [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of HYCODAN, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2) ] . Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering HYCODAN. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering HYCODAN [see Dosage and Administration (2.1) , Warnings and Precautions (5.5) ] . Cytochrome P450 3A4 Interaction The concomitant use of HYCODAN with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of HYCODAN in patients taking a CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.7) , Drug Interactions (7.2 , 7.3) ] . Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death . Avoid the use of HYCODAN in patients taking benzodiazepines, other CNS depressants, or alcohol [see Warnings and Precautions (5.8) , Drug Interactions (7.5) ] . Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking HYCODAN. The co-ingestion of alcohol with HYCODAN may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Warnings and Precautions (5.8) , Drug Interactions (7.1) ] . Neonatal Opioid Withdrawal Syndrome HYCODAN is not recommended for use in pregnant women [see Use in Specific Populations (8.1) ]. Prolonged use of HYCODAN during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If HYCODAN is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.13) ] .

Common side effects

• Sedation
• Impaired mental and physical performance
• Lightheadedness
• Dizziness
• Headache
• Dry mouth
• Nausea
• Vomiting
• Constipation
• Anaphylaxis
• Coma
• Death

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Hycodan CI brief — competitive landscape report
• Hycodan updates RSS · CI watch RSS
• Endo portfolio CI