MORPHINE SULFATE FDA MedWatch Direct Reports Summary

These tables and charts are created from 991 voluntary U.S. reports for MORPHINE SULFATE (MORPHINE SULFATE) 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 MORPHINE SULFATE Report.

Top Adverse Effects Associated with MORPHINE SULFATE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DEATH	176
2	NAUSEA	59
3	DISEASE PROGRESSION	52
4	DRUG INEFFECTIVE	46
5	PAIN	42
6	VOMITING	40
7	FATIGUE	38
8	DIARRHEA	37
9	HOSPICE CARE	33
10	PRODUCT SUBSTITUTION ISSUE	30
11	HEADACHE	29
12	HOSPITALIZATION	29
13	DIZZINESS	28
14	RASH	28
15	SHORTNESS OF BREATH	26
16	THERAPY CESSATION	24
17	ABDOMINAL PAIN	22
18	PRODUCT DISPENSING ERROR	20
19	THERAPY INTERRUPTED	20
20	CONSTIPATION	19
21	PRODUCT QUALITY ISSUE	19
22	PNEUMONIA	18
23	LACK OF STRENGTH AND ENERGY (ASTHENIA)	17
24	BACK PAIN	17
25	DROWSINESS	16

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MORPHINE SULFATE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
373	494	124	991

Medwatch Reporter Type	Count
Consumer	254
Physician	76
Pharmacist	240
Other Health Professional	220

Top Indications

Product used for unknown indication
Pain
LUNG CONGESTION
Analgesic therapy
Breakthrough pain

Type of Outcome Reported
Serious: 657
Not Serious: 334
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: 990
Concomitant Drugs: 767
Note: A single MedWatch report can list more than one drug. This summary includes MORPHINE SULFATE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

MORPHINE SULFATE (MORPHINE SULFATE) Rx Drug:
REMS

Shared FDA Risk Evaluation and Mitigation Strategy

MORPHINE SULFATE (MORPHINE SULFATE) Rx Drug:
FDA Safety-related Labeling Changes

KADIAN (MORPHINE SULFATE) Rx Drug:
FDA Safety-related Labeling Changes

EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

MORPHABOND (MORPHINE SULFATE) Rx Drug:
FDA Safety-related Labeling Changes

ARYMO ER (MORPHINE SULFATE) Discontinued Drug:
FDA Safety-related Labeling Changes

DURAMORPH PF (MORPHINE SULFATE) Rx Drug:
FDA Safety-related Labeling Changes

MS CONTIN (MORPHINE SULFATE) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with MS CONTIN? Rate MS CONTIN 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.