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What the label lists and what reports show

Hydrocodone and ibuprofen side effects

Hydrocodone and ibuprofen's FDA label lists its adverse reactions in its own words. FAERS holds 467 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 dependence (269 reports).

  • Generic listed
  • Boxed warning
  • DEA Schedule II

Check it at the source: the hydrocodone and ibuprofen FDA label on DailyMed (effective November 21, 2025, Amneal Pharmaceuticals of New York LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions are described below and elsewhere in the labeling including the WARNINGS section. Addiction, Abuse, and Misuse Life-Threatening Respiratory Depression Neonatal Opioid Withdrawal Syndrome Interactions with Cytochrome P450 3A4 Inhibitors and Inducers Interactions with Benzodiazepines or Other CNS Depressants Adrenal Insufficiency Severe Hypotension Seizures Withdrawal Cardiovascular Thrombotic Events Gastrointestinal Bleeding, Ulceration, and Perforation Hepatotoxicity Hypertension Heart Failure and Edema Renal Toxicity and Hyperkalemia Anaphylactic Reactions Exacerbation of Asthma Related to Aspirin Sensitivity Serious Skin Reactions Premature Closure of Fetal Ductus Arteriosus Hematologic Toxicity Aseptic Meningitis Opioid-Induced Hyperalgesia and Allodynia (see WARNINGS ) Clinical Trials Experience Because clinical trials are conducted under widely …

Source: FDA drug label, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025 (SPL set abc33718-4e88-43ea-9ffa-2b04ffc812ef), via openFDA; the full label on DailyMed

What do FAERS reports show?

467 reports list hydrocodone and ibuprofen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 82 are coded as a death and 37 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 17 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.

The 25 most reported reactions

  • Dependence (named in the label)269
  • Overdose (a use or a product term, not a reaction)166
  • Death (an outcome recorded in the report)44
  • Drug Dependence33
  • Ill-Defined Disorder33
  • Depression29
  • Pain (a use or a product term, not a reaction)23
  • Drug Ineffective (a use or a product term, not a reaction)19
  • Withdrawal Syndrome19
  • Product Prescribing Issue (a use or a product term, not a reaction)18
  • Anxiety (named in the label)17
  • Nausea (named in the label)16
  • Vomiting (named in the label)12
  • Drug Diversion10
  • Drug Withdrawal Syndrome10
  • Post-Traumatic Stress Disorder10
  • Pruritus (named in the label)10
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)9
  • Completed Suicide (an outcome recorded in the report)8
  • Drug Abuse (named in the label)8
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)8
  • Hallucination8
  • Headache (named in the label)8
  • Dizziness (named in the label)7
  • Mental Disorder (named in the label)7

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Hydrocodone and ibuprofen: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions