What the label lists and what reports show
Hydrocodone side effects
Hydrocodone's FDA label: “Most common treatment-emergent adverse events (incidence ≥ 5%) are constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.” FAERS holds 43,191 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 (10,364 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the hydrocodone FDA label on DailyMed (effective May 29, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common treatment-emergent adverse events (incidence ≥ 5%) are constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.
Table 2: Adverse Reactions Reported in ≥2% of Patients during the Open-Label Titration Period and Double-Blind Treatment Period: Patients Who Were Not Opioid Tolerant and Opioid-Experienced Patients
| MedDRA Preferred Term | (N=905) (%) | Placebo (N=292) (%) | HYSINGLA ER (N=296) (%) |
|---|---|---|---|
| Nausea | 16 | 5 | 8 |
| Constipation | 9 | 2 | 3 |
| Vomiting | 7 | 3 | 6 |
| Dizziness | 7 | 2 | 3 |
| Headache | 7 | 2 | 2 |
| Somnolence | 5 | 1 | 1 |
| Fatigue | 4 | 1 | 1 |
| Pruritus | 3 | <1 | 0 |
| Tinnitus | 2 | 1 | 2 |
| Insomnia | 2 | 2 | 3 |
| Decreased appetite | 1 | 1 | 2 |
| Influenza | 1 | 1 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13 , 5.14) ] Seizures [see Warnings and Precautions (5.15) ] Withdrawal [see Warnings and Precautions (5.16) ] Most common treatment-emergent adverse events (incidence ≥ 5%) are constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Knoa Pharma LLC at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Knoa Pharma LLC, effective May 29, 2026 (SPL set b7d23ac2-e776-9f62-3290-c64c2d6eb353), via openFDA; the full label on DailyMed
What do FAERS reports show?
43,191 reports list hydrocodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 21,422 are coded as a death and 4,422 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 2018 (21,042, against a median of 918 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, 9 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?
- 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