TRAMADOL HYDROCHLORIDE FDA MedWatch Direct Reports Summary

These tables and charts are created from 156 voluntary U.S. reports for TRAMADOL HYDROCHLORIDE (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 TRAMADOL HYDROCHLORIDE Report.

Top Adverse Effects Associated with TRAMADOL HYDROCHLORIDE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	NAUSEA	14
2	HEADACHE	13
3	DIZZINESS	11
4	FALL	10
5	MENTAL STATUS CHANGES	10
6	CONFUSIONAL STATE	9
7	DEATH	8
8	PAIN	8
9	VOMITING	8
10	DRUG INEFFECTIVE	7
11	PRODUCT SUBSTITUTION ISSUE	7
12	HOSPITALIZATION	6
13	ITCHING	6
14	SEIZURE	6
15	HIVES	6
16	ACUTE KIDNEY INJURY	5
17	JOINT PAIN	5
18	LACK OF STRENGTH AND ENERGY (ASTHENIA)	5
19	SHORTNESS OF BREATH	5
20	PALPITATIONS	5
21	RASH	5
22	ABDOMINAL PAIN UPPER	4
23	CONDITION AGGRAVATED	4
24	DECREASED APPETITE	4
25	DIARRHEA	4

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TRAMADOL HYDROCHLORIDE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
61	86		156

Medwatch Reporter Type	Count
Consumer	43
Physician	1
Pharmacist	43
Other Health Professional	29

Top Indications

Product used for unknown indication
Pain
Back pain
JOINT PAIN
Procedural pain

Type of Outcome Reported
Serious: 107
Not Serious: 49
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: 155
Concomitant Drugs: 94
Note: A single MedWatch report can list more than one drug. This summary includes TRAMADOL HYDROCHLORIDE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

TRAMADOL (TRAMADOL HYDROCHLORIDE) Rx Drug:
REMS

Shared FDA Risk Evaluation and Mitigation Strategy

ULTRAM (TRAMADOL HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

ULTRAM ER (TRAMADOL HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

CONZIP (TRAMADOL HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with CONZIP? Rate CONZIP 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.