Gablofen: adverse event reports filed with FDA

3,068

reports as suspect product

0% of all reports · about 206 a year

93

reports, 12 months to June 2026

112 in the 12 months before

50.2%

marked serious by the reporter

77.9% across the class

3.8%

record death among outcomes, as reported

117 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 Gablofen reports recording the termmedian drug in gamma-aminobutyric acid-ergic agonist

1. Muscle spasticity24.8%761
2. Withdrawal syndrome13.4%410
3. Device issuea problem with the device12.2%375
4. Drug ineffectivethe medicine did not work as expected9.4%289
5. Drug withdrawal syndromesymptoms on stopping a medicine8.8%269
6. Overdosea dose above the recommended amount5.5%168
7. Implant site infection5.3%164
8. Infectionan infection, type not specified5.3%162
9. Device failurethe device failed5%153
10. Hypertonia5%153
11. Pruritusitching4.9%150
12. Device malfunctionthe device did not work properly4.8%148
13. Muscle spasmsmuscle cramps4.7%143
14. Painpain, site not specified4%123
15. Implant site extravasation4%122
16. Pyrexiafever3.4%104
17. Cerebrospinal fluid leakage3.2%99
18. Muscle tightness2.6%80
19. Underdoseless than the intended dose2.5%78
20. Device dislocationthe device moved out of position2.5%77
21. Headachehead pain2.5%77
22. Hypotonia2.5%77
23. Falla fall2.3%72
24. Device infusion issuea problem with infusion by the device2.3%70
25. Musculoskeletal stiffnessstiffness in muscles or joints2.2%69
26. Device occlusionthe device blocked2.1%64
27. Agitationrestlessness2.1%63
28. Device breakagethe device broke2%62
29. Urinary tract infectionbladder or urinary infection2%61
30. Device kink1.9%58

Top 30 of 362 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 3 drugs in the gamma-aminobutyric acid-ergic 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 35,901 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. 99.8% 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 3,068 reports.

Drugs most often listed in the same reports

Other products listed in reports where Gablofen 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 gamma-aminobutyric acid-ergic 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 Gablofen as a suspect or interacting product; reports listing it only as a concomitant medication (19) 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.