What the label lists and what reports show
Tramadol side effects
Tramadol's FDA label: “Most common adverse reactions (≥10% and ≥2 x placebo rate): Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.” FAERS holds 37,421 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 (7,827 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the tramadol FDA label on DailyMed (effective March 5, 2026, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10% and ≥2 x placebo rate): Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.
Table 1: Incidence (%) of patients with adverse reaction rates ≥ 5% from two 12-week placebo-controlled studies in patients with moderate to moderately severe chronic pain by dose (N=1811).
| Reaction | 100 mg (N=403) n (%) | 200 mg (N=400) n (%) | 300 mg (N=400) n (%) | 400 mg (N=202) n (%) | (N=406) n (%) |
|---|---|---|---|---|---|
| Dizziness (not vertigo) | 64 (16) | 81 (20) | 90 (23) | 57 (28) | 28 (7) |
| Nausea | 61 (15) | 90 (23) | 102 (26) | 53 (26) | 32 (8) |
| Constipation | 49 (12) | 68 (17) | 85 (21) | 60 (30) | 17 (4) |
| Headache | 49 (12) | 62 (16) | 46 (12) | 32 (16) | 43 (11) |
| Somnolence | 33 (8) | 45 (11) | 29 (7) | 41 (20) | 7 (2) |
| Flushing | 31 (8) | 40 (10) | 35 (9) | 32 (16) | 18 (4) |
| Pruritus | 25 (6) | 34 (9) | 30 (8) | 24 (12) | 4 (1) |
| Vomiting | 20 (5) | 29 (7) | 34 (9) | 19 (9) | 11 ( 3) |
| Insomnia | 26 (7) | 32 (8) | 36 (9) | 22 (11) | 13 (3) |
| Dry Mouth | 20 (5) | 29 (7) | 39 (10) | 18 (9) | 6 (2) |
| Diarrhea | 15 (4) | 27 (7) | 37 (9) | 10 (5) | 17 (4) |
| Asthenia | 14 (4) | 24 (6) | 26 (7) | 13 (6) | 7 (2) |
| Postural hypotension | 7 (2) | 17 (4) | 8 (2) | 11 (5) | 9 (2) |
| Sweating increased | 6 (2) | 8 (2) | 15 (4) | 13 (6) | 1 (0) |
| Anorexia | 3 (1) | 7 (2) | 21 (5) | 12 (6) | 1 (0) |
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 or otherwise important adverse reactions are 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 )] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.3 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions ( 5.6 )] Opioid-Induced Hyperalgesia and Allodynia [See Warnings and Precautions ( 5.8 )] Serotonin Syndrome [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] Suicide [see Warnings and Precautions ( 5.11 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.13 )] Severe Hypotension [see Warnings and Precautions ( 5.14 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.16 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.17 )] Withdrawal [see Warnings and Precautions ( 5.18 )] Most common adverse reactions (≥10% and ≥2 x placebo rate): Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth.
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective March 5, 2026 (SPL set 46bb9ae6-3ee8-463c-badb-c7a45a89b84b), via openFDA; the full label on DailyMed
What do FAERS reports show?
37,421 reports list tramadol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,344 are coded as a death and 11,704 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 2023 (9,950, against a median of 2,308 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 10 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?
- 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