What the label lists and what reports show
Dextromethorphan and promethazine side effects
Dextromethorphan and promethazine's FDA label lists its adverse reactions in its own words. FAERS holds 598 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (58 reports).
- Generic listed
- Boxed warning
Check it at the source: the dextromethorphan and promethazine FDA label on DailyMed (effective August 8, 2025, ANI Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsPROMETHAZINE Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. …
Source: FDA drug label, NDA011265 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective August 8, 2025 (SPL set a52e210f-b99d-493e-b679-ec565c6ff72d), via openFDA; the full label on DailyMed
What do FAERS reports show?
598 reports list dextromethorphan and promethazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 142 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dextromethorphan and promethazine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions