Sublocade: adverse event reports filed with FDA

5,028

reports as suspect product

0% of all reports · about 610 a year

434

reports, 12 months to June 2026

537 in the 12 months before

20.3%

marked serious by the reporter

60.2% across the class

1.5%

record death among outcomes, as reported

76 reports · not verified by FDA

Reports by month, five years

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

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Sublocade reports recording the termmedian drug in partial opioid agonist

1. Drug withdrawal syndromesymptoms on stopping a medicine21.4%1,077
2. Injection site painpain where the injection was given15.3%770
3. Drug dependencedependence on a medicine7.6%381
4. Inappropriate schedule of product administrationthe product was taken at the wrong times6.2%312
5. Injection site erythemaredness where the injection was given5.4%274
6. Drug abusemisuse of a medicine4.8%240
7. Nauseafeeling sick4.3%216
8. Wrong technique in product usage processthe product was used in the wrong way3.4%173
9. Euphoric mood3.2%160
10. Injection site infection3%151
11. Injection site extravasation2.8%141
12. Fatiguetiredness2.6%133
13. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.6%132
14. Off label useused for a purpose or in a way not on the label2.5%127
15. Vomitingbeing sick2.5%127
16. Anxietyanxiety2.3%116
17. Hyperhidrosisexcessive sweating2.2%110
18. Headachehead pain2.2%109
19. Injection site swellingswelling where the injection was given2.2%109
20. Injection site pruritusitching where the injection was given2.1%105
21. Somnolencedrowsiness2.1%105
22. Oedema peripheralswelling of the legs, ankles or hands2%99
23. Drug delivery system removal1.9%97
24. Drug screen negative1.9%97
25. Product administered at inappropriate site1.9%94
26. Injection site induration1.8%91
27. Injection site necrosisdeath of tissue where the injection was given1.8%88
28. Insomniadifficulty sleeping1.8%88
29. Painpain, site not specified1.7%83
30. Constipationconstipation1.6%81

Top 30 of 372 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 8 drugs in the partial 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

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 94,902 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 96.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,028 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sublocade 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

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 partial opioid agonist class

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.

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 Sublocade as a suspect or interacting product; reports listing it only as a concomitant medication (101) 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.