What the label lists and what reports show
Acetaminophen and tramadol side effects
Acetaminophen and tramadol's FDA label: “The most common incidence of treatment-emergent adverse events (≥3.0%) in patients from clinical trials were constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.” FAERS holds 908 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 nausea (86 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the acetaminophen and tramadol FDA label on DailyMed (effective November 17, 2025, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common incidence of treatment-emergent adverse events (≥3.0%) in patients from clinical trials were constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN label published by Asclemed USA, Inc. of October 30, 2020; the label quoted above does not print one.
| Body System Preferred Term | Tramadol Hydrochloride and Acetaminophen (N=142) (%) Gastrointestinal System Disorders |
|---|---|
| Constipation | 6 |
| Diarrhea | 3 |
| Nausea | 3 |
| Dry Mouth | 2 |
| Somnolence | 6 |
| Anorexia | 3 |
| Insomnia | 2 |
| Dizziness | 3 |
| Sweating Increased | 4 |
| Pruritus | 2 |
| Prostatic Disorder | 2 |
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 discussed, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see Warnings and Precautions (5.6) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.9) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Opioid-Induced Hyperalgesia and Allodynia [See Warnings and Precautions (5.8) ] Serotonin Syndrome [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Suicide [see Warnings and Precautions (5.12) ] Adrenal Insufficiency [see Warnings and Precautions (5.14) ] Severe Hypotension [see Warnings and Precautions (5.15) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.18) ] Hypersensitivity Reactions [see Warnings and Precautions (5.19) ] Withdrawal [see Warnings and Precautions (5.21) ] The most common incidence of treatment-emergent adverse events (≥3.0%) in patients from clinical trials were constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.
Source: FDA drug label, Aurobindo Pharma Limited, effective November 17, 2025 (SPL set 6c2894df-eeeb-4b22-ab32-8ce1601bfdfa), via openFDA; the full label on DailyMed
What do FAERS reports show?
908 reports list acetaminophen and tramadol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 128 are coded as a death and 392 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 19 reactions below, 11 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 tramadol: 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