Glassia (.alpha.1-proteinase inhibitor human) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Glassia
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: .alpha.1-proteinase inhibitor human
Class: Human alpha-1 proteinase inhibitor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From April 2011 to June 2026, FDA received 2,273 adverse event reports that name Glassia. In these reports the drug is a suspect or interacting product.

In the same period, 60 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 267 reports in the 12 months to June 2026 and 332 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 267 (under 0.1%) name Glassia. Reports from consumers or other non-health professionals were 64.8% of the reports that name Glassia and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Glassia is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 26 reports that name Glassia.
In January to March 2026, FDA received 100.
In April to June 2025, FDA received 74.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 278 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,267 of the 2,273 reports (99.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 278 terms.

Reaction terms in the reports that name Glassia, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,273 reports
Dyspnoeashortness of breath	347	15.3%
Pneumonialung infection	346	15.2%
Product dose omission issuea dose was missed	266	11.7%
Inappropriate schedule of product administrationthe product was taken at the wrong times	250	11%
Deaththe patient died; cause not stated by this term	214	9.4%
Fatiguetiredness	211	9.3%
Headachehead pain	204	9%
Cough	175	7.7%
Blood pressure increaseda raised blood pressure reading	150	6.6%
Covid-19COVID-19 infection	141	6.2%
Malaisegeneral feeling of being unwell	140	6.2%
Insurance issue	135	5.9%
Nasopharyngitisa cold	134	5.9%
Falla fall	130	5.7%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	128	5.6%
Oxygen saturation decreased	121	5.3%
Bronchitischest infection	114	5%
Weight decreasedweight loss	113	5%
Productive cougha cough with phlegm	104	4.6%
Sinusitissinus infection	104	4.6%
Nauseafeeling sick	102	4.5%
Painpain, site not specified	94	4.1%
Product use issuea problem in how the product was used	88	3.9%
Respiratory tract infectiona respiratory infection	88	3.9%
Diarrhoealoose or frequent stools	84	3.7%
Dizzinesslight-headedness or unsteadiness	83	3.7%
Pyrexiafever	83	3.7%
Illness	82	3.6%
Incorrect dose administeredthe wrong dose was given	81	3.6%
Influenzaflu	80	3.5%
Poor venous access	78	3.4%
Vomitingbeing sick	73	3.2%
Astheniaweakness or lack of energy	71	3.1%
Weight increasedweight gain	69	3%
Arthralgiajoint pain	66	2.9%
Back pain	66	2.9%
Chest discomfort	65	2.9%
Blood pressure fluctuation	62	2.7%
Heart rate increaseda fast heart rate reading	62	2.7%
Contusiona bruise	61	2.7%
Urinary tract infectionbladder or urinary infection	59	2.6%
Extra dose administered	57	2.5%
Infectionan infection, type not specified	55	2.4%
Lower respiratory tract infectiona chest infection	55	2.4%
Upper respiratory tract infectiona cold or similar infection	54	2.4%
Pain in extremitypain in an arm or leg	51	2.2%
Blood pressure decreaseda low blood pressure reading	50	2.2%
Chest pain	50	2.2%
Lung disordera lung problem, type not specified	49	2.2%
Oxygen saturation abnormal	47	2.1%

Download all 278 terms of Glassia (CSV)

The counts add to more than 2,273 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of .alpha.1-proteinase inhibitor human with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
.alpha.1-proteinase inhibitor human	Generic name	590
Glassia (this page)	Brand name	2,273

Sum of the separately reported names: 2,863. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Glassia, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2011	6	5	1	0	4	0	0	2	1
2012	22	20	9	0	9	0	0	4	2
2013	66	64	7	5	39	3	0	21	2
2014	83	79	6	4	49	3	0	29	4
2015	80	78	26	2	33	0	0	35	2
2016	150	91	20	0	56	0	0	28	59
2017	248	165	15	0	88	0	0	84	83
2018	29	10	2	0	3	0	0	6	19
2019	57	50	10	1	23	0	0	24	7
2020	211	44	5	1	21	0	0	28	167
2021	199	156	28	0	80	0	0	85	43
2022	125	100	29	3	54	0	0	82	25
2023	137	99	36	2	39	2	0	82	38
2024	173	129	42	2	57	1	0	112	44
2025	409	343	49	3	184	1	0	294	66
2026	278	264	26	1	132	0	1	227	14

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Glassia, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Glassia, by the year in which FDA received them
Year	Reports
2011	8
2012	25
2013	63
2014	82
2015	79
2016	153
2017	251
2018	30
2019	84
2020	319
2021	121
2022	187
2023	180
2024	266
2025	299
2026	126

Reports that name Glassia, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Glassia
Age	Reports	Share
Under 2	0	0%
2 to 11	1	under 0.1%
12 to 17	1	under 0.1%
18 to 44	78	3.4%
45 to 64	431	19%
65 to 74	295	13%
75 and over	130	5.7%
Age not given	1,337	58.8%

Sex of the patient in the reports that name Glassia
Sex	Reports	Share
Female	809	35.6%
Male	641	28.2%
Unknown or not given	823	36.2%

Type of reporter in the reports that name Glassia
Reporter	Reports	Share
Physician	146	6.4%
Pharmacist	101	4.4%
Other health professional	521	22.9%
Lawyer	0	0%
Consumer or non-health professional	1,473	64.8%
Not given	32	1.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 89.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Glassia record
Indication as recorded (MedDRA)	Reports	Share
Alpha-1 antitrypsin deficiency	1,225	53.9%
Alpha-1 anti-trypsin deficiency	530	23.3%
Graft versus host disease	13	0.6%
Prophylaxis	13	0.6%
Supplementation therapy	13	0.6%
Emphysema	11	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,273 reports.

Drugs in the same reports

Other drugs that the reports of Glassia name, in any role, in order of name
Drug	Reports that name the two
Albuterol sulfate	337
Diphenhydramine	460
Epinephrine	559
Ergocalciferol	234
Lidocaine	302
Oxygen	410
Prednisone	262
Sodium chloride	550
Symbicort	236
Tiotropium bromide	300

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

.alpha.1-proteinase inhibitor human same ingredient
Prolastin-C Liquid same class
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Glactiv next in the A to Z list
Glatiramer next in the A to Z list
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Ginkgo next in the A to Z list
Glatiramer acetate next in the A to Z list
Gimoti next in the A to Z list
Glatiramer Acetate 40mg/Ml Mylan next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for GlassiaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Glassia: adverse event reports that FDA received. https://reportedreactions.com/drug/glassia/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Glassia as a suspect or interacting product. The 60 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Glassia was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Glassia?

No. It is a count of what people reported to FDA: 2,273 reports from April 2011 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (64.8%), other health professional (22.9%) and physician (6.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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