FDA Adverse Events Reports (FAERS) Summary for MORPHINE SULFATE

These tables and charts are based on 84,157 total reports for MORPHINE SULFATE (MORPHINE SULFATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 83,166 pharmaceutical company-submitted and non-U.S. FAERS reports and 991 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 991 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch MORPHINE SULFATE summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with MORPHINE SULFATE (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG DEPENDENCE	20559
2	OVERDOSE	12591
3	PAIN	11484
4	DRUG HYPERSENSITIVITY	10494
5	EMOTIONAL DISTRESS	6943
6	DEATH	5854
7	NAUSEA	5072
8	DEPENDENCE	4922
9	DRUG INEFFECTIVE	4894
10	DRUG WITHDRAWAL SYNDROME	4790
11	VOMITING	3680
12	FATIGUE	3608
13	ANXIETY	3258
14	TOXICITY TO VARIOUS AGENTS	3211
15	HEADACHE	3193
16	DRUG ABUSE	3012
17	OFF LABEL USE	2993
18	CONSTIPATION	2901
19	DIARRHEA	2599
20	DEPRESSION	2546
21	SHORTNESS OF BREATH	2527
22	FALL	2151
23	PNEUMONIA	2145
24	MALAISE	2107
25	FEVER	2099
26	RASH	2059
27	DROWSINESS	1861
28	JOINT PAIN	1840
29	LACK OF STRENGTH AND ENERGY (ASTHENIA)	1812
30	DIZZINESS	1801
31	WEIGHT DECREASED	1730
32	LOW BLOOD PRESSURE	1694
33	CONFUSIONAL STATE	1685
34	ITCHING	1682
35	BACK PAIN	1653
36	ABDOMINAL PAIN	1591
37	FOETAL EXPOSURE DURING PREGNANCY	1558
38	DECREASED APPETITE	1524
39	INSOMNIA	1520
40	DRUG INTOLERANCE	1487
41	HIGH BLOOD PRESSURE	1461
42	HYPERSENSITIVITY	1445
43	RHEUMATOID ARTHRITIS	1419
44	EXCESS SWEATING	1398
45	DRUG WITHDRAWAL SYNDROME NEONATAL	1368
46	PAIN IN EXTREMITY	1333
47	CONDITION AGGRAVATED	1322
48	ILL-DEFINED DISORDER	1319
49	JOINT SWELLING	1306
50	GENERAL PHYSICAL HEALTH DETERIORATION	1263
51	DEVELOPMENTAL DELAY	1251
52	LEARNING DISABILITY	1245
53	INFUSION RELATED REACTION	1196
54	DRUG INTERACTION	1144
55	MOBILITY DECREASED	1106
56	INJURY	1097
57	WITHDRAWAL SYNDROME	1079
58	SEDATION	1068
59	MENTAL DISORDER	1063
60	ANEMIA	1047
61	CARDIAC DISORDER	1040
62	INFECTION	1036
63	GAIT DISTURBANCE	1033
64	PRODUCT USE IN UNAPPROVED INDICATION	1024
65	DEPRESSED LEVEL OF CONSCIOUSNESS	1015
66	DISABILITY	1007
67	ABDOMINAL DISCOMFORT	1004
68	CHEST PAIN	984
69	SWELLING OF LIMBS	983
70	ASTHMA	940
71	MUSCULOSKELETAL STIFFNESS	933
72	COUGH	929
73	PRODUCT USE ISSUE	921
74	HIVES	921
75	NUMBNESS	917
76	LOSS OF CONSCIOUSNESS	914
77	COMMON COLD	908
78	ARTHRITIS	888
79	BALANCE DISORDER	886
80	WEIGHT INCREASED	882
81	ABDOMINAL PAIN UPPER	881
82	MATERNAL EXPOSURE DURING PREGNANCY	879
83	SUBSTANCE ABUSE	865
84	SKIN REDNESS	851
85	ELEVATED LIVER ENZYMES	840
86	FEELING ABNORMAL	837
87	TREMOR	836
88	UNEVALUABLE EVENT	821
89	DIFFICULTY SWALLOWING	808
90	UPPER RESPIRATORY TRACT INFECTION	806
91	PSORIASIS	805
92	COGNITIVE DISORDER	804
93	AMNESIA	796
94	ACUTE KIDNEY INJURY	788
95	MEMORY IMPAIRMENT	787
96	ROAD TRAFFIC ACCIDENT	777
97	LOWER LIMBS SWELLING	776
98	COMPLETED SUICIDE	774
99	HALLUCINATION	764
100	MACULAR DEGENERATION	759

Latest Known Outcomes for Reactions Reported for MORPHINE SULFATE

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	54335
2	Patient died	12322
3	Patient recovered	10525
4	Patient has not recovered/symtoms have not resolved	8964
5	Patient is recovering/symptoms resolving	3750
6	Patient has recovered but has consequent health issues	503

Search all MedWatch and FAERS by keyword:

MORPHINE SULFATE Total Reports

Male	Female	Unknown	Total
35166	41757	7234	84,157

Top Countries Reporting

	Country	Number of Reports
1	United States	54151
2	Canada	8773
3	United Kingdom	4327
4	France	2372
5	Germany	695
6	EU	688
7	Australia	474
8	Spain	338
9	Italy	280
10	China	257

Outcomes for Reports

Serious: 66835
Not Serious: 17307
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
Pain
LUNG CONGESTION
Analgesic therapy
Breakthrough pain

Top Companies Reporting

PURDUE
PFIZER
STRIDES
ALKEM

Safety-Related FDA Updates

FDA Approval Date: 2006-10-27

MORPHINE SULFATE (MORPHINE SULFATE) Rx Drug:
Shared FDA Risk Evaluation and Mitigation Strategy REMS

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

Have experience (good or bad) with MORPHINE SULFATE? Rate MORPHINE SULFATE at Ask a Patient.

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

Have experience (good or bad) with KADIAN? Rate KADIAN at Ask a Patient.

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

Have experience (good or bad) with EMBEDA? Rate EMBEDA at Ask a Patient.

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

Have experience (good or bad) with MORPHABOND? Rate MORPHABOND at Ask a Patient.

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

Have experience (good or bad) with ARYMO ER? Rate ARYMO ER at Ask a Patient.

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

Have experience (good or bad) with DURAMORPH PF? Rate DURAMORPH PF at Ask a Patient.

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 MORPHINE SULFATE 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.