Over-the-counter medication · Antitussive
dextromethorphan
Also sold as Delsym, Robitussin. This medicine temporarily relieves symptoms from a cold.
- 7,480
- FDA reportsLightly reported
- 15
- InteractionsSeveral interactions
- 2
- Recall records
What the data shows
dextromethorphan (Delsym) is an over-the-counter Antitussive, reported less often than most tracked drugs (7,480 FDA reports), with 15 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
dextromethorphan (Delsym) is an over-the-counter Antitussive. This medicine temporarily relieves symptoms from a cold.
Dextromethorphan is a medicine that helps to relieve coughs. It can also help with cold and flu symptoms.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$0.08/unit
Generic Price
$0.12/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine temporarily relieves symptoms from a cold.
Common side effects
Dizziness, Nausea, Headache
Key warnings
Do not use in children under 12 years of age.
The sections below are summarized in plain English from dextromethorphan's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Dextromethorphan works by decreasing the activity in the part of your brain that causes you to cough. This helps to reduce your urge to cough. It does not treat the underlying cause of the cough.
How to Take It
Adults and children 12 years and over should take 30 mL every 4 hours. Do not take more than directed. Do not take more than 6 doses (180 mL) in any 24-hour period. Only measure with the provided dosing cup.
This is a plain-language summary of dextromethorphan's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. It is not known if this medicine will harm your unborn baby. It is also not known if this medicine passes into breast milk.
This is a plain-language summary of dextromethorphan's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take more than the recommended dose in 24 hours.
This is a plain-language summary of dextromethorphan's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 7,480 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dextromethorphan, by number of reports
- Misusing the medicine
Misusing the medicine
713 reports
- Poisoning
Poisoning
678 reports
- Taking too much medicine
Taking too much medicine
594 reports
- Feeling lightheaded
Feeling lightheaded
435 reports
- Accidentally taking too much medicine
Accidentally taking too much medicine
403 reports
- Loose stool
Loose stool
394 reports
- Death by suicide
Death by suicide
333 reports
- Death
Death
321 reports
- Cough
Cough
307 reports
- Feeling sick to your stomach 281
Feeling sick to your stomach
281 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dextromethorphan each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dextromethorphan sits
dextromethorphan has more FDA adverse-event reports than 33% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dextromethorphan; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 7,480 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
7,480
Reports Mentioning Death
1,756
23.5% of reports — not proof of cause
Hospitalization Reports
1,400
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DRUG ABUSE | 713 |
| 3 | TOXICITY TO VARIOUS AGENTS | 678 |
| 4 | OVERDOSE | 594 |
| 5 | DIZZINESS | 435 |
| 6 | ACCIDENTAL OVERDOSE | 403 |
| 7 | DIARRHOEA | 394 |
| 8 | COMPLETED SUICIDE | 333 |
| 9 | DEATH | 321 |
| 10 | COUGH | 307 |
| 11 | NAUSEA | 281 |
| 13 | DYSPNOEA | 232 |
| 14 | FATIGUE | 230 |
| 15 | VOMITING | 229 |
| 16 | DRUG INTERACTION | 223 |
| 17 | HEADACHE | 215 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not use in children under 12 years of age.
Known Drug Interactions
7.4 Dextromethorphan The combination of MAOIs and dextromethorphan has been reported to cause episodes of psychosis or bizarre behavior. Therefore, in view of XADAGO's MAO inhibitory activity, dextromethorphan is contraindicated for use with XADAGO.
Mechanism: Safinamide is an MAO inhibitor, and taking it with dextromethorphan can cause serious mental side effects like psychosis or strange behavior.
What to do: Do not take these two medications together.
7.2 Use with Other N-methyl-D-aspartate (NMDA) Antagonists The combined use of memantine hydrochloride with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Mechanism: Both of these drugs affect the same receptors in the brain, and using them together has not been well studied. This could cause unknown side effects or change how the medications work.
What to do: Use this combination with caution and only if your doctor says it is necessary. Watch for any unusual changes in how you feel and report them to your provider.
7 DRUG INTERACTIONS Meperidine: Risk of serotonin syndrome (4, 7.1) Dextromethorphan: Risk of psychosis or bizarre behavior (4, 7.2) MAO inhibitors: Risk of non-selective MAO inhibition and hypertensive crisis (4, 7.3) 7.1 Meperidine Serious, sometimes fatal reactions have been precipitated with concomitant use of meperidine (e.g., Demerol and other tradenames) and MAO inhibitors including selective MAO-B inhibitors [see Contraindications (4)] . 7.2 Dextromethorphan The concomitant use of rasagiline tablets and dextromethorphan was not allowed in clinical studies. The combination of MAO...
Mechanism: Taking these drugs at the same time can cause severe changes in your brain chemistry. This can lead to unusual behavior, confusion, or a loss of touch with reality.
What to do: Avoid using these medications together. Check the labels of over-the-counter cough medicines to make sure they do not contain dextromethorphan.
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the...
Mechanism: These medicines can interact to cause a dangerous spike in blood pressure or a harmful buildup of serotonin. They both affect the way your nervous system manages chemical signals.
What to do: Avoid taking these drugs together. Ask your doctor or pharmacist for a different cough medicine that does not interact with your antidepressant.
In a CYP2D6 drug-drug interaction trial, the C max and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily.
Mechanism: Abiraterone stops your body from breaking down dextromethorphan normally. This causes the amount of dextromethorphan in your blood to increase significantly.
What to do: Talk to your doctor before taking these together, as you may need a lower dose of dextromethorphan to avoid side effects.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I accidentally take too much?
Can I take this with other medicines?
How long does it take for this medicine to work?
Can I drink alcohol while taking this medicine?
Will this medicine make me sleepy?
Can I drive while taking this medicine?
What if my cough doesn't get better?
Can I give this to my baby?
How often can I take this?
What is the best way to measure the dose?
What are the common side effects of dextromethorphan?
Does dextromethorphan interact with other medications?
What drug class is dextromethorphan?
Is dextromethorphan safe during pregnancy?
Has dextromethorphan been recalled?
Active Recalls
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Denison Pharmaceuticals, LLC
CGMP Deviations: product held outside appropriate storage temperature conditions.
Family Dollar Stores, Llc.
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Medication Guides
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What the FDA Data Shows for dextromethorphan
The FDA label for dextromethorphan (sold under brand names such as Delsym, Robitussin) classifies it as an over-the-counter product in the Antitussive class. This medicine temporarily relieves symptoms from a cold. Official labeling lists 4 commonly reported side effects, including Dizziness, Nausea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,480 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.12 versus $0.08 for the brand.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 27, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages