FDA Adverse Events Reports (FAERS) Summary for MS CONTIN

These tables and charts are based on 59,798 total reports for MS CONTIN (MORPHINE SULFATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 59,387 pharmaceutical company-submitted and non-U.S. FAERS reports and 411 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 411 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch MS CONTIN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with MS CONTIN (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG DEPENDENCE	27081
2	OVERDOSE	18076
3	PAIN	14859
4	EMOTIONAL DISTRESS	14024
5	DEATH	13547
6	DRUG WITHDRAWAL SYNDROME	12080
7	TOXICITY TO VARIOUS AGENTS	9400
8	DRUG ABUSE	2217
9	DRUG WITHDRAWAL SYNDROME NEONATAL	2062
10	DEPRESSION	1780
11	ANXIETY	1704
12	NAUSEA	1211
13	FOETAL EXPOSURE DURING PREGNANCY	1169
14	LEARNING DISABILITY	1011
15	VOMITING	872
16	MENTAL DISORDER	855
17	DEVELOPMENTAL DELAY	849
18	FATIGUE	781
19	ACCIDENTAL OVERDOSE	743
20	DISABILITY	738
21	UNEVALUABLE EVENT	719
22	DIARRHEA	709
23	CONSTIPATION	707
24	INJURY	640
25	SHORTNESS OF BREATH	627
26	WITHDRAWAL SYNDROME	616
27	DRUG INEFFECTIVE	615
28	CARDIAC DISORDER	606
29	PNEUMONIA	543
30	INSOMNIA	521
31	HEADACHE	504
32	BACK PAIN	496
33	DROWSINESS	493
34	LACK OF STRENGTH AND ENERGY (ASTHENIA)	492
35	FALL	476
36	ROAD TRAFFIC ACCIDENT	452
37	SUICIDAL IDEATION	446
38	GENERAL PHYSICAL HEALTH DETERIORATION	445
39	FEVER	443
40	CONFUSIONAL STATE	435
41	AMNESIA	430
42	MATERNAL EXPOSURE DURING PREGNANCY	425
43	DIZZINESS	416
44	DECREASED APPETITE	404
45	MALAISE	404
46	DEPENDENCE	399
47	ABDOMINAL PAIN	390
48	WEIGHT DECREASED	389
49	DEHYDRATION	364
50	JOINT PAIN	357
51	INTENTIONAL PRODUCT MISUSE	353
52	ANEMIA	347
53	SUICIDE ATTEMPT	335
54	PAIN IN EXTREMITY	333
55	HOSPITALIZATION	330
56	OFF LABEL USE	308
57	CHEST PAIN	306
58	TOOTH LOSS	306
59	EXPOSURE DURING PREGNANCY	303
60	CANCER PROGRESSION	302
61	ILLNESS	292
62	SELF ESTEEM DECREASED	292
63	IMPAIRED WORK ABILITY	284
64	MEMORY IMPAIRMENT	282
65	RASH	282
66	HEPATITIS C	279
67	EXCESS SWEATING	277
68	HIGH BLOOD PRESSURE	275
69	SEPSIS	265
70	SWELLING OF LIMBS	259
71	TREMOR	259
72	DISEASE PROGRESSION	248
73	FEELING ABNORMAL	244
74	LOSS OF CONSCIOUSNESS	243
75	SEIZURE	239
76	POST-TRAUMATIC STRESS DISORDER	237
77	MUSCLE SPASMS	235
78	INFECTION	227
79	GAIT DISTURBANCE	224
80	LOW BLOOD PRESSURE	224
81	KIDNEY FAILURE	223
82	ABDOMINAL PAIN UPPER	221
83	URINARY TRACT INFECTION	219
84	CONDITION AGGRAVATED	210
85	HALLUCINATION	208
86	DISTURBANCE IN ATTENTION	207
87	COUGH	204
88	WEIGHT INCREASED	199
89	STROKE	196
90	ITCHING	190
91	DRUG TOLERANCE	189
92	NUMBNESS	189
93	HEART ATTACK (MYOCARDIAL INFARCTION)	187
94	DRUG DIVERSION	182
95	CONGENITAL ANOMALY	181
96	MENTAL IMPAIRMENT	179
97	RESPIRATORY FAILURE	179
98	SUBSTANCE USE DISORDER	174
99	PLEURAL EFFUSION	171
100	PULMONARY EMBOLISM	170

Latest Known Outcomes for Reactions Reported for MS CONTIN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	34765
2	Patient died	22734
3	Patient recovered	2720
4	Patient has not recovered/symtoms have not resolved	2695
5	Patient is recovering/symptoms resolving	964
6	Patient has recovered but has consequent health issues	104

Search all MedWatch and FAERS by keyword:

MS CONTIN Total Reports

Male	Female	Unknown	Total
20484	15794	23520	59,798

Top Countries Reporting

	Country	Number of Reports
1	United States	54555
2	Canada	1084
3	Japan	284
4	China	267
5	Australia	138
6	Belgium	51
7	Italy	43
8	EU	10
9	Netherlands	10
10	United Kingdom	7

Outcomes for Reports

Serious: 57476
Not Serious: 2322
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Analgesic therapy
Pain
Metastases to bone
Cancer pain

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 1993-11-08

MS CONTIN (MORPHINE SULFATE) Rx Drug:
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 the cases for MS CONTIN reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.