Drug · FAERS side-effect profile with label screen

Tramadol side effects: what 37,420 FDA adverse event reports show

Tramadol Hydrochloride · 1,201 reaction terms · 280,537 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Tramadol Hydrochloride (Tramadol Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

37,420 reports · 90% serious · 7,344 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Tramadol hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limita.

FDA label, Indications and Usage

What it is

Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use.

FDA label, Description section

Boxed warning

SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of tramadol hydrochloride extended-release tablets exposes patients and othe.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Lab value / disease marker 9Not in label — unassessed 26

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,161 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic enzyme	78	717.5 512.5–1,004.5ROR 719.0 · calibrated p 6e-15 ✓	290.3 EB05 240.1 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=78 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
C-reactive protein	319	305.1 266.2–349.7ROR 307.8 · calibrated p 9e-12 ✓	194.6 EB05 177.3 · IC025 +7.1 3/3 methods agree	Lab value / disease marker	serious n=319 · ♀ 100% (drug 61%) · 98% clinician	not reported in cached trials
Hypocholesterolaemia	97	258.6 203.3–329.1ROR 259.3 · calibrated p 7e-11 ✓	170.6 EB05 143.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=97 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
Facet joint syndrome	868	213.5 197.5–230.7ROR 218.5 · calibrated p 2e-10 ✓	153.7 EB05 145.3 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=868 · ♀ 100% (drug 61%) · 96% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	173	196.5 165.2–233.6ROR 197.4 · calibrated p 6e-10 ✓	142.9 EB05 125.9 · IC025 +6.4 3/3 methods agree	Lab value / disease marker	serious n=173 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
Rheumatic fever	1,035	174.3 162.7–186.8ROR 179.3 · calibrated p 1e-9 ✓	132.4 EB05 125.8 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=1,035 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Lupus vulgaris	276	169.5 148.1–193.8ROR 170.7 · calibrated p 2e-9 ✓	128.7 EB05 116.5 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=276 · ♀ 100% (drug 61%) · 95% clinician	not reported in cached trials
Ejection fraction	127	155.8 128.0–189.6ROR 156.3 · calibrated p 4e-9 ✓	119.6 EB05 103.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=127 · ♀ 100% (drug 61%)	not reported in cached trials
Deep vein thrombosis postoperative	414	150.1 134.7–167.3ROR 151.8 · calibrated p 5e-9 ✓	117.6 EB05 108.4 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=414 · ♀ 100% (drug 61%) · 95% clinician	not reported in cached trials
Analgesic drug level above therapeutic	31	150.1 100.9–223.2ROR 150.2 · calibrated p 2e-8 ✓	110.3 EB05 81.4 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=31 · ♀ 0% (drug 61%)	not reported in cached trials
Swollen joint count increased	654	148.9 136.6–162.2ROR 151.5 · calibrated p 4e-9 ✓	117.1 EB05 109.7 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=654 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Swollen joint count	49	139.4 101.9–190.7ROR 139.6 · calibrated p 2e-8 ✓	106.9 EB05 84.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
Sensitisation	150	136.6 114.3–163.3ROR 137.2 · calibrated p 1e-8 ✓	108.2 EB05 94.5 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=150 · ♀ 100% (drug 61%)	not reported in cached trials
Amaurosis fugax	192	122.7 104.9–143.4ROR 123.3 · calibrated p 3e-8 ✓	99.6 EB05 88.3 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=192 · 94% clinician	not reported in cached trials
Peripheral venous disease	669	112.8 103.9–122.5ROR 114.9 · calibrated p 4e-8 ✓	93.6 EB05 87.8 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious n=669 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Duodenal ulcer perforation	1,111	100.0 93.8–106.5ROR 103.0 · calibrated p 9e-8 ✓	84.7 EB05 80.6 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 54.0 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Retinitis	242	95.0 82.9–108.8ROR 95.6 · calibrated p 2e-7 ✓	80.7 EB05 72.5 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=242 · ♀ 100% (drug 61%) · 95% clinician	not reported in cached trials
Dislocation of vertebra	320	94.1 83.7–106.0ROR 95.0 · calibrated p 2e-7 ✓	80.2 EB05 73.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=320 · ♀ 100% (drug 61%) · 94% clinician	not reported in cached trials
Adjustment disorder with depressed mood	288	93.4 82.5–105.8ROR 94.1 · calibrated p 2e-7 ✓	79.6 EB05 72.2 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=288 · ♀ 100% (drug 61%) · 96% clinician	not reported in cached trials
Dependence	7,827	91.9 89.9–93.9ROR 116.0 · calibrated p 4e-8 ✓	78.9 EB05 77.5 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 50.7 · 100% consumer	not reported in cached trials
Seronegative arthritis	149	85.8 72.2–101.9ROR 86.1 · calibrated p 4e-7 ✓	73.7 EB05 64.3 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=149 · ♀ 100% (drug 61%) · 94% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	924	83.7 78.2–89.7ROR 85.8 · calibrated p 4e-7 ✓	72.7 EB05 68.9 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious PRR 46.6 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Grip strength	30	83.2 56.7–122.1ROR 83.3 · calibrated p 1e-6 ✓	69.4 EB05 50.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=30 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
Learning disorder	308	81.0 71.9–91.2ROR 81.7 · calibrated p 5e-7 ✓	70.5 EB05 64.1 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=308 · 100% consumer	not reported in cached trials
Subcutaneous drug absorption impaired	67	78.5 60.8–101.4ROR 78.7 · calibrated p 1e-6 ✓	67.6 EB05 55.1 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious n=67 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
C-reactive protein abnormal	786	78.3 72.7–84.4ROR 80.0 · calibrated p 6e-7 ✓	68.6 EB05 64.7 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=786 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Rheumatoid factor positive	697	77.0 71.2–83.3ROR 78.4 · calibrated p 7e-7 ✓	67.6 EB05 63.4 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=697 · ♀ 100% (drug 61%) · 98% clinician	not reported in cached trials
Onychomadesis	492	75.2 68.5–82.6ROR 76.2 · calibrated p 9e-7 ✓	66.2 EB05 61.4 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=492 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Folliculitis	1,223	75.2 70.9–79.8ROR 77.7 · calibrated p 7e-7 ✓	66.3 EB05 63.2 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 49.7 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Breast cancer stage iii	757	74.7 69.3–80.5ROR 76.2 · calibrated p 8e-7 ✓	65.8 EB05 62.0 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=757 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Nasal oedema	208	73.5 63.6–84.9ROR 73.9 · calibrated p 1e-6 ✓	64.6 EB05 57.6 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious n=207 · ♀ 100% (drug 61%) · 93% clinician	not reported in cached trials
Lip dry	986	69.3 64.9–73.9ROR 71.1 · calibrated p 1e-6 ✓	61.6 EB05 58.4 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=986 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Antidepressant drug level above therapeutic	28	68.1 46.0–100.8ROR 68.1 · calibrated p 4e-6 ✓	58.4 EB05 42.4 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=28 · ♀ 0% (drug 61%) · 100% clinician	not reported in cached trials
Muscle injury	884	67.6 63.1–72.4ROR 69.2 · calibrated p 2e-6 ✓	60.3 EB05 57.0 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.7 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Helicobacter infection	1,089	67.0 63.0–71.3ROR 69.0 · calibrated p 2e-6 ✓	59.8 EB05 56.9 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 40.3 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
X-ray abnormal	190	66.7 57.4–77.5ROR 67.0 · calibrated p 2e-6 ✓	59.3 EB05 52.5 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	serious n=190 · ♀ 100% (drug 61%) · 100% clinician	not reported in cached trials
Neutropenia neonatal	23	63.5 41.2–97.7ROR 63.5 · calibrated p 7e-6 ✓	54.6 EB05 38.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=23	not reported in cached trials
Physical deconditioning	252	62.7 55.0–71.3ROR 63.1 · calibrated p 3e-6 ✓	56.1 EB05 50.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=252	not reported in cached trials
Blepharospasm	607	60.7 55.9–66.0ROR 61.7 · calibrated p 4e-6 ✓	54.7 EB05 51.2 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=605 · ♀ 100% (drug 61%) · 97% clinician	not reported in cached trials
Speech disorder developmental	278	59.7 52.8–67.6ROR 60.2 · calibrated p 4e-6 ✓	53.8 EB05 48.7 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=278 · ♀ 37% (drug 61%) · 100% consumer	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Dependence / withdrawal	10,297	20.219.9–20.5	signal
Depression	2,228	4.54.3–4.6	signal
Liver injury	2,276	4.34.1–4.4	signal
Suicidality	1,557	3.63.4–3.7	signal
Interstitial lung disease	585	3.43.2–3.7	signal
Hyperglycaemia / diabetes	1,651	2.72.6–2.8	signal
Serious infection	3,514	2.62.5–2.6	signal
Rhabdomyolysis / myopathy	361	2.52.3–2.8	signal
Hyponatraemia	343	2.42.2–2.7	signal
Anaphylaxis / angioedema	491	2.22.0–2.4	signal
Seizure	724	2.11.9–2.2	raised
Fall / fracture	1,370	2.01.9–2.1	raised
Severe cutaneous reaction	246	1.91.6–2.1	raised
Gi bleeding	594	1.81.7–2.0	raised
Kidney injury	1,464	1.81.7–1.9	raised
Pancreatitis	244	1.71.5–1.9	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Tramadol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

NCT02528253 — A Phase 3 Study of Tanezumab for Chronic Low Back Pain (N=1832, PHASE3; 98 AE terms posted; arms: Placebo (Week 16); Safety Evaluation: Tanezumab 5 mg; Safety Evaluation: Tanezumab 10 mg; Tramadol)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dependence	7,827	91.9 89.9–93.9ROR 116.0 · calibrated p 4e-8 ✓	78.9 EB05 77.5 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 50.7 · 100% consumer	not reported in cached trials
Overdose	3,907	10.3 10.0–10.6ROR 11.4 · calibrated p 0.021 ✓	10.1 EB05 9.8 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 4.7 · serious PRR 8.1 · 76% consumer	not reported in cached trials
Vomiting	3,421	4.1 4.0–4.2ROR 4.4 · calibrated p 0.307	4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.7 · serious PRR 3.7 · ♀ 89% (drug 61%)	not reported in cached trials
Pain	3,085	2.8 2.7–2.9ROR 3.0 · calibrated p 0.632	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 3.3 · serious PRR 2.7 · ♀ 81% (drug 61%)	NCT02528253: 1/506 (0.2%) on Tramadol (serious AE)
Nausea	2,905	2.1 2.0–2.1ROR 2.2 · calibrated p 0.973	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.2 · serious PRR 2.3	NCT02528253: 1/602 (0.2%) on Tramadol (serious AE)
Drug ineffective (drug did not work)	2,710	1.2 1.1–1.2ROR 1.2 · calibrated p 0.417	1.2 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	age-adj. PRR 1.8 · serious PRR 1.7	not reported in cached trials
Dyspnoea (shortness of breath)	2,454	2.4 2.3–2.5ROR 2.5 · calibrated p 0.797	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.8 · serious PRR 2.1 · ♀ 88% (drug 61%)	not reported in cached trials
Headache	2,427	2.2 2.1–2.3ROR 2.3 · calibrated p 0.923	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.4 · serious PRR 2.7 · ♀ 89% (drug 61%)	NCT02528253: 50/602 (8.3%) on Tramadol; 13/215 (6.0%) control
Off label use (used outside approved label)	2,425	1.6 1.5–1.6ROR 1.6 · calibrated p 0.711	1.6 EB05 1.5 · IC025 +0.6	Reporting / coding artifact	age-adj. PRR 2.1 · serious PRR 1.8 · ♀ 82% (drug 61%)	not reported in cached trials
Fatigue (tiredness)	2,403	1.7 1.7–1.8ROR 1.8 · calibrated p 0.822	1.7 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 1.9 · ♀ 86% (drug 61%)	not reported in cached trials
Drug hypersensitivity	2,274	6.6 6.4–6.9ROR 7.0 · calibrated p 0.099	6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 8.2 · serious PRR 9.3 · ♀ 94% (drug 61%)	NCT02528253: 1/602 (0.2%) on Tramadol (serious AE)
Drug dependence	2,191	7.6 7.3–8.0ROR 8.0 · calibrated p 0.065	7.5 EB05 7.3 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 8.3 · serious PRR 4.9	not reported in cached trials
Dizziness	2,072	2.3 2.2–2.4ROR 2.4 · calibrated p 0.850	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.5 · serious PRR 2.5 · ♀ 87% (drug 61%)	NCT02528253: 44/602 (7.3%) on Tramadol; 4/215 (1.9%) control
Pneumonia (lung infection)	2,053	3.6 3.4–3.7ROR 3.7 · calibrated p 0.433	3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.3 · serious PRR 2.4 · ♀ 90% (drug 61%)	NCT02528253: 1/602 (0.2%) on Tramadol (serious AE)
Arthralgia (joint pain)	2,051	2.8 2.7–2.9ROR 2.9 · calibrated p 0.665	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.8 · serious PRR 3.1 · ♀ 89% (drug 61%)	NCT02528253: 65/602 (10.8%) on Tramadol; 22/215 (10.2%) control

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Hepatic enzyme — n=78, PRR 717.5
Hypocholesterolaemia — n=97, PRR 258.6
Facet joint syndrome — n=868, PRR 213.5
Rheumatic fever — n=1,035, PRR 174.3
Lupus vulgaris — n=276, PRR 169.5
Ejection fraction — n=127, PRR 155.8
Deep vein thrombosis postoperative — n=414, PRR 150.1
Swollen joint count — n=49, PRR 139.4
Sensitisation — n=150, PRR 136.6
Amaurosis fugax — n=192, PRR 122.7

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tramadol ↔ Seizures.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Tramadol?

In FDA FAERS, the most frequently co-reported reaction terms for Tramadol are dependence, vomiting, pain, nausea, dyspnoea, headache. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Tramadol have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of tramadol hydrochloride extended-release tablets exposes patients and othe.

Do FAERS signals prove that Tramadol causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 004de5a4-80f8-4040-a6ea-be5e99352a36, effective 20251120; matched on openfda.generic_name.exact:"TRAMADOL HYDROCHLORIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,201 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query TRAMADOL, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.