Reported Reactions

Drugs › Opioid agonist

Brand name · Morphine sulfate

MS Contin: adverse event reports filed with FDA

52,128 reports list it as a suspect or interacting product, 2004–2026. Class: Opioid agonist. Also reported as Ms Contin Tablets.

52,128
reports as suspect product
0.3% of all reports · about 2,317 a year
55
reports, 12 months to June 2026
42 in the 12 months before
98.7%
marked serious by the reporter
91.7% across the class
42.4%
record death among outcomes, as reported
22,110 reports · not verified by FDA

Between January 2004 and June 2026, 52,128 adverse event reports received by FDA list the brand name MS Contin (morphine sulfate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (7,300) are left out of every figure here.

In the 12 months to June 2026, 55 reports listed it, up 31% from 42 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 2,317 reports a year and 0.3% of the 20,646,523 reports in the database, and 5.4% of the reports for the opioid agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded drug dependence (51.8%), overdose (34.5%) and pain (27.4%). A report can list several reactions, so shares add to more than 100%; 1,161 different terms appear across these reports. Drug dependence is recorded in 51.8% of these reports, a larger share than in the median opioid agonist drug (5.6%).

98.7% of the reports are marked serious by the reporter (91.7% across the class); 42.4% record death among the outcomes and 7.2% record hospitalisation, as reported. 76.8% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (1.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

02,7005,399Jul 2021: 48Aug 2021: 410Sep 2021: 62Oct 2021: 25Nov 2021: 1,930Dec 2021: 3,4282022Jan 2022: 5,399Feb 2022: 510Mar 2022: 354Apr 2022: 12May 2022: 481Jun 2022: 221Jul 2022: 30Aug 2022: 24Sep 2022: 4Oct 2022: 757Nov 2022: 19Dec 2022: 1002023Jan 2023: 3Feb 2023: 13Mar 2023: 3Apr 2023: 9May 2023: 2Jun 2023: 6Jul 2023: 2Aug 2023: 17Sep 2023: 0Oct 2023: 64Nov 2023: 33Dec 2023: 142024Jan 2024: 16Feb 2024: 3Mar 2024: 4Apr 2024: 7May 2024: 3Jun 2024: 7Jul 2024: 2Aug 2024: 1Sep 2024: 4Oct 2024: 3Nov 2024: 0Dec 2024: 42025Jan 2025: 5Feb 2025: 4Mar 2025: 5Apr 2025: 5May 2025: 3Jun 2025: 6Jul 2025: 5Aug 2025: 2Sep 2025: 1Oct 2025: 5Nov 2025: 2Dec 2025: 52026Jan 2026: 5Feb 2026: 9Mar 2026: 7Apr 2026: 6May 2026: 6Jun 2026: 2

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

010,58321,1662004: 14320042005: 1092006: 602007: 5920072008: 452009: 402010: 7820102011: 672012: 962013: 22820132014: 2102015: 1442016: 13720162017: 1,7572018: 21,1662019: 11620192020: 4,7292021: 14,7302022: 7,91120222023: 1662024: 542025: 4820252026: 35

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of MS Contin reports recording the termmedian drug in opioid agonist

  1. Drug dependencedependence on a medicine51.8%27,006
  2. Overdosea dose above the recommended amount34.5%17,997
  3. Painpain, site not specified27.4%14,263
  4. Emotional distressemotional distress26.8%13,958
  5. Deaththe patient died; cause not stated by this term25%13,019
  6. Drug withdrawal syndromesymptoms on stopping a medicine23%12,012
  7. Toxicity to various agentspoisoning or toxic effect of one or more substances18%9,378
  8. Drug abusemisuse of a medicine4.2%2,201
  9. Depressionlow mood3%1,566
  10. Anxietyanxiety2.8%1,446
  11. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.2%1,159
  12. Developmental delayslower development in a child1.6%842
  13. Disability1.4%714
  14. Accidental overdosean accidental overdose1.4%713
  15. Unevaluable eventthe event could not be assessed1.3%683
  16. Injurya physical injury1.1%565
  17. Maternal exposure during pregnancythe mother took the medicine during pregnancy0.8%420
  18. Constipationconstipation0.8%414
  19. Road traffic accidenta road accident0.8%409
  20. Suicidal ideationthoughts of suicide0.8%393
  21. Dependence0.7%382
  22. Nauseafeeling sick0.7%370
  23. Amnesiamemory loss0.7%367
  24. Vomitingbeing sick0.7%350
  25. Intentional product misusedeliberate use not as intended0.7%343

Top 30 of 1,161 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 42 drugs in the opioid agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death42.4%22,110
Life-threatening0.3%152
Hospitalisation (initial or prolonged)7.2%3,766
Disability12.7%6,627
Congenital anomaly2.1%1,100
Other serious61.9%32,247
Not serious1.3%683

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 965,051 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20.2%101
2 to 110%15
12 to 170.1%35
18 to 441.1%592
45 to 641.7%868
65 to 740.6%297
75 and over0.4%198
Age not given96%50,022

Patient sex

Female22.8%11,882
Male32.6%16,980
Not given44.6%23,266

Who reported

Physician1.2%645
Pharmacist0.3%148
Other health professional1.1%583
Lawyer76.8%40,015
Consumer or non-health professional20.3%10,564
Not given0.3%173

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 96.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Pain23,65645.4%
Back pain2420.5%
Cancer pain1140.2%
Pain management1070.2%
Foetal exposure during pregnancy840.2%
Back injury770.1%

The indication field is filled in by the reporter and is often blank; shares are of all 52,128 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of MS Contin reports
OxyContin46,68689.6%
Oxycodone hydrochloride40,75578.2%
Dilaudid37,93172.8%
Butrans27,63353%
Hysingla ER25,78849.5%
Percocet24,30946.6%
Hydromorphone24,15646.3%
Opana23,45245%
Opana Er22,88243.9%
Percodan22,79843.7%

Other products listed in reports where MS Contin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasureMS ContinOpioid agonistAll reports
Reports as suspect product52,128965,05120,646,523
Share of that pool—5.4%0.3%
Reports, latest 12 months55—1,332,454
Marked serious98.7%91.7%57.4%
Death recorded among outcomes, per 1,000 reports42435791
Hospitalisation recorded, per 1,000 reports72126213
Consumer-filed share20.3%32.5%45.8%
Top term, share of reportsDrug dependence 51.8%median 5.6%0.8%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the opioid agonist class

DrugName typeReportsLatest 12 monthsMarked serious
OxyContinbrand146,26358494.6%
Oxycodone hydrochloridegeneric113,2202,59894.7%
Dilaudidbrand64,19117395.7%
Morphine sulfategeneric60,0921,57779.8%
Hydrocodone bitartrate and acetaminophengeneric59,05217096.2%
Percocetbrand57,79319895.4%
Fentanylgeneric53,6563,29286.2%
Oxycodonegeneric35,6712,85391.8%
Hysingla ERbrand30,703692.1%
Morphinegeneric28,4211,42190.5%
Nucyntabrand27,57512790.4%
Tramadol hydrochloridegeneric27,4471,95292.4%
Oxycodone and acetaminophengeneric24,91911294%
Norcobrand24,6614293.1%
Methadonegeneric24,29390994.7%

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Questions about MS Contin reports

How many adverse event reports has FDA received for MS Contin?

52,128 reports list MS Contin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 55 of them arrived in the latest 12 months. Another 7,300 list it only as a concomitant medication.

What reactions are recorded in MS Contin reports?

drug dependence (51.8%), overdose (34.5%), pain (27.4%), emotional distress (26.8%) and death (25%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that MS Contin was responsible.

How serious are the reports?

98.7% are marked serious by the reporter. Among the outcomes recorded, 42.4% of reports include death and 7.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

lawyer (76.8%), consumer or non-health professional (20.3%) and physician (1.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for MS Contin rising?

55 reports in the 12 months to June 2026, up 31% from 42 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that MS Contin was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of MS Contin?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists MS Contin as a suspect or interacting product; reports listing it only as a concomitant medication (7,300) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.