ULTRAM FDA MedWatch Direct Reports Summary
These tables and charts are created from 437 voluntary U.S. reports for ULTRAM (TRAMADOL HYDROCHLORIDE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS ULTRAM Report.
Top Adverse Effects Associated with ULTRAM (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 NAUSEA 40 2 SHORTNESS OF BREATH 34 3 PAIN 34 4 DIZZINESS 31 5 HEADACHE 29 6 DIARRHEA 26 7 FATIGUE 26 8 LACK OF STRENGTH AND ENERGY (ASTHENIA) 23 9 DRUG INEFFECTIVE 23 10 VOMITING 20 11 PRODUCT SUBSTITUTION ISSUE 18 12 RASH 16 13 JOINT PAIN 15 14 DEATH 14 15 LOW BLOOD SUGAR 14 16 CHILLS 13 17 CONFUSIONAL STATE 13 18 FALL 13 19 THERAPY CESSATION 13 20 HAEMORRHAGIC ANAEMIA 12 21 INSOMNIA 12 22 MUSCLE PAIN 12 23 ABDOMINAL PAIN 11 24 ACUTE KIDNEY INJURY 11 25 ANEMIA 11
ULTRAM Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 123 | 304 | 10 | 437 |
| Medwatch Reporter Type | Count |
| Consumer | 112 |
| Physician | 28 |
| Pharmacist | 139 |
| Other Health Professional | 65 |
| Top Indications | |
| Product used for unknown indication | |
Type of Outcome Reported
Serious: 349
Not Serious: 88
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 437
Concomitant Drugs: 402
Note: A single MedWatch report can list more than one drug. This summary includes ULTRAM identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
ULTRAM (TRAMADOL HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes
Have experience (good or bad) with ULTRAM? Rate ULTRAM at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.