DEXTROMETHORPHAN: 5,174 Adverse Event Reports & Safety Profile
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Drug Class: Sigma-1 Agonist [EPC] · Route: ORAL · Manufacturer: Cardinal Health 107, LLC · HUMAN OTC DRUG · FDA Label: Available
First Report: 1967 · Latest Report: 20250916
What Are the Most Common DEXTROMETHORPHAN Side Effects?
All DEXTROMETHORPHAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 1,204 | 23.3% | 26 | 50 |
| Drug abuse | 625 | 12.1% | 485 | 77 |
| Toxicity to various agents | 618 | 11.9% | 510 | 142 |
| Overdose | 504 | 9.7% | 72 | 76 |
| Accidental overdose | 356 | 6.9% | 43 | 8 |
| Dizziness | 339 | 6.6% | 30 | 42 |
| Completed suicide | 289 | 5.6% | 288 | 65 |
| Diarrhoea | 270 | 5.2% | 29 | 33 |
| No adverse event | 240 | 4.6% | 1 | 2 |
| Death | 213 | 4.1% | 213 | 9 |
| Somnolence | 167 | 3.2% | 5 | 22 |
| Nausea | 154 | 3.0% | 21 | 28 |
| Cough | 153 | 3.0% | 1 | 37 |
| Vomiting | 148 | 2.9% | 32 | 40 |
| Insomnia | 137 | 2.7% | 24 | 30 |
| Dyspnoea | 130 | 2.5% | 31 | 78 |
| Intentional overdose | 121 | 2.3% | 29 | 61 |
| Headache | 117 | 2.3% | 23 | 29 |
| Condition aggravated | 112 | 2.2% | 36 | 56 |
| Malaise | 106 | 2.1% | 29 | 62 |
Who Reports DEXTROMETHORPHAN Side Effects? Age & Gender Data
Gender: 58.6% female, 41.4% male. Average age: 41.2 years. Most reports from: US. View detailed demographics →
Is DEXTROMETHORPHAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 1 | 1 |
| 2005 | 1 | 0 | 1 |
| 2006 | 1 | 1 | 0 |
| 2007 | 3 | 1 | 1 |
| 2008 | 1 | 1 | 0 |
| 2009 | 5 | 5 | 0 |
| 2010 | 1 | 1 | 0 |
| 2011 | 5 | 3 | 2 |
| 2012 | 90 | 88 | 0 |
| 2013 | 56 | 53 | 2 |
| 2014 | 133 | 16 | 15 |
| 2015 | 316 | 7 | 9 |
| 2016 | 308 | 20 | 13 |
| 2017 | 298 | 42 | 17 |
| 2018 | 210 | 32 | 15 |
| 2019 | 155 | 6 | 7 |
| 2020 | 115 | 28 | 4 |
| 2021 | 93 | 10 | 15 |
| 2022 | 137 | 7 | 9 |
| 2023 | 95 | 15 | 21 |
| 2024 | 49 | 1 | 7 |
| 2025 | 8 | 0 | 2 |
What Is DEXTROMETHORPHAN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 2,981 |
| Cough | 1,388 |
| Nasopharyngitis | 83 |
| Drug abuse | 52 |
| Suicide attempt | 36 |
| Respiratory tract congestion | 26 |
| Antitussive therapy | 20 |
| Complex regional pain syndrome | 20 |
| Covid-19 | 17 |
| Oropharyngeal pain | 15 |
DEXTROMETHORPHAN vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Sigma-1 Agonist [EPC]
Official FDA Label for DEXTROMETHORPHAN
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Indication and usage section Indication and usage section Do nor exceed recommended dosage Do not take more than 6 doses in any 24 hours period Adults and children 12 years and over 10 ml every 4 hours Children 6 to under 12 years age 5 ml every 4 hours Children 4 to under 6 years age 2.5 ml every 4 hours Children under 4 years of age Consult a doctor indication an user
Dosage & Administration
Directions shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use
Warnings
WARNINGS Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- you are hypersensitive to any of the ingredients. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient
DESCRIPTION Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg Dextromethorphan Hydrobromide 10 mg Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.
Sodium
Content: 4 mg/5 mL
Inactive Ingredients
Inactive ingredients magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Questions or comments? Call weekdays between 10 a.m. to 4 p.m. CST, at 833-289-7626 or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice. Distributed by: DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200 Katy, TX 77 494 www.RoboCough.com Patent Pending.