Glassia: adverse event reports filed with FDA

2,273

reports as suspect product

0% of all reports · about 149 a year

267

reports, 12 months to June 2026

332 in the 12 months before

74.7%

marked serious by the reporter

60.1% across the class

13.7%

record death among outcomes, as reported

311 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 Glassia reports recording the termmedian drug in human alpha-1 proteinase inhibitor

1. Dyspnoeashortness of breath15.3%347
2. Pneumonialung infection15.2%346
3. Product dose omission issuea dose was missed11.7%266
4. Inappropriate schedule of product administrationthe product was taken at the wrong times11%250
5. Deaththe patient died; cause not stated by this term9.4%214
6. Fatiguetiredness9.3%211
7. Headachehead pain9%204
8. Coughcough7.7%175
9. Blood pressure increaseda raised blood pressure reading6.6%150
10. Covid-19COVID-19 infection6.2%141
11. Malaisegeneral feeling of being unwell6.2%140
12. Insurance issue5.9%135
13. Nasopharyngitisa cold5.9%134
14. Falla fall5.7%130
15. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease5.6%128
16. Oxygen saturation decreased5.3%121
17. Bronchitischest infection5%114
18. Weight decreasedweight loss5%113
19. Productive cougha cough with phlegm4.6%104
20. Sinusitissinus infection4.6%104
21. Nauseafeeling sick4.5%102
22. Painpain, site not specified4.1%94
23. Product use issuea problem in how the product was used3.9%88
24. Respiratory tract infectiona respiratory infection3.9%88
25. Diarrhoealoose or frequent stools3.7%84
26. Dizzinesslight-headedness or unsteadiness3.7%83
27. Pyrexiafever3.7%83
28. Illness3.6%82
29. Incorrect dose administeredthe wrong dose was given3.6%81
30. Influenzaflu3.5%80

Top 30 of 512 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 human alpha-1 proteinase inhibitor 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 4,163 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. 89.8% 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 2,273 reports.

Drugs most often listed in the same reports

Other products listed in reports where Glassia 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 human alpha-1 proteinase inhibitor 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 Glassia as a suspect or interacting product; reports listing it only as a concomitant medication (60) 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.