What the label lists and what reports show
Acetaminophen and hydrocodone side effects
Acetaminophen and hydrocodone's FDA label: “The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.” FAERS holds 56,022 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 drug dependence (33,295 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the acetaminophen and hydrocodone FDA label on DailyMed (effective October 23, 2025, Elite Laboratories, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.
From the label: adverse reactions, continuedThe following adverse reactions have been identified during post approval use of hydrocodone bitartrate and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include: Central Nervous System - Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System - Constipation. Genitourinary System - Ureteral spasm, spasm of vesical sphincters, and urinary retention. Special Senses - Cases of Hearing impairment, or permanent loss have been reported predominately in patients with chronic overdose. Dermatological - Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions. Hematological - Thrombocytopenia, agranulocytosis. Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. …
Source: FDA drug label, Elite Laboratories, Inc., effective October 23, 2025 (SPL set 89b8145f-5310-4b58-a65d-586dc90d642d), via openFDA; the full label on DailyMed
What do FAERS reports show?
56,022 reports list acetaminophen and hydrocodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8,227 are coded as a death and 7,199 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. Reports rose sharply in 2021 (19,947, against a median of 2,147 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, 8 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?
- Acetaminophen and hydrocodone: 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