Drugs › Human alpha-1 proteinase inhibitor
Generic name
Alpha.1-proteinase inhibitor human: adverse event reports filed with FDA
590 reports list it as a suspect or interacting product, 2015–2026. Class: Human alpha-1 proteinase inhibitor.
- 590
- reports as suspect product
- 0% of all reports · about 55 a year
- 172
- reports, 12 months to June 2026
- 139 in the 12 months before
- 90.2%
- marked serious by the reporter
- 60.1% across the class
- 17.5%
- record death among outcomes, as reported
- 103 reports · not verified by FDA
Between November 2015 and June 2026, 590 adverse event reports received by FDA list alpha.1-proteinase inhibitor human, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (7) are left out of every figure here.
In the 12 months to June 2026, 172 reports listed it, up 24% from 139 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 55 reports a year and 0% of the 20,646,523 reports in the database, and 14.2% of the reports for the human alpha-1 proteinase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are pneumonia (27.5%), dyspnoea (25.4%) and product dose omission issue (23.7%). A report can list several reactions, so shares add to more than 100%; 350 different terms appear across these reports. Pneumonia is recorded in 27.5% of these reports, a larger share than in the median human alpha-1 proteinase inhibitor drug (15.2%).
90.2% of the reports are marked serious by the reporter (60.1% across the class); 17.5% record death among the outcomes and 51.5% record hospitalisation, as reported. 67.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (26.1%). 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
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 Alpha.1-proteinase inhibitor human reports recording the termmedian drug in human alpha-1 proteinase inhibitor
- Pneumonialung infection27.5%162
- Dyspnoeashortness of breath25.4%150
- Product dose omission issuea dose was missed23.7%140
- Covid-19COVID-19 infection15.9%94
- Coughcough15.1%89
- Deaththe patient died; cause not stated by this term13.4%79
- Falla fall13.4%79
- Fatiguetiredness11%65
- Respiratory tract infectiona respiratory infection10.7%63
- Productive cougha cough with phlegm10.3%61
- Sinusitissinus infection9.8%58
- Painpain, site not specified9.5%56
- Inappropriate schedule of product administrationthe product was taken at the wrong times9.2%54
- Insurance issue9.2%54
- Nasopharyngitisa cold8.5%50
- Upper respiratory tract infectiona cold or similar infection7.8%46
- Bronchitischest infection7.5%44
- Malaisegeneral feeling of being unwell7.5%44
- Product use issuea problem in how the product was used7.3%43
- Headachehead pain7.1%42
- Illness7.1%42
- Nauseafeeling sick6.6%39
- Urinary tract infectionbladder or urinary infection6.6%39
- Dizzinesslight-headedness or unsteadiness6.4%38
- Arthralgiajoint pain6.1%36
- Back painback pain6.1%36
- Influenzaflu6.1%36
- Weight decreasedweight loss5.9%35
- Pyrexiafever5.6%33
- Diarrhoealoose or frequent stools5.4%32
Top 30 of 350 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 90.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Alpha-1 antitrypsin deficiency | 499 | 84.6% |
| Graft versus host disease | 8 | 1.4% |
| Emphysema | 7 | 1.2% |
| Chronic obstructive pulmonary disease | 5 | 0.8% |
| Graft versus host disease in gastrointestinal tract | 5 | 0.8% |
| Immune system disorder | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 590 reports.
In context
| Measure | Alpha.1-proteinase inhibitor human | Human alpha-1 proteinase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 590 | 4,163 | 20,646,523 |
| Share of that pool | — | 14.2% | 0% |
| Reports, latest 12 months | 172 | — | 1,332,454 |
| Marked serious | 90.2% | 60.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 175 | 113 | 91 |
| Hospitalisation recorded, per 1,000 reports | 515 | 319 | 213 |
| Consumer-filed share | 67.3% | 65.4% | 45.8% |
| Top term, share of reports | Pneumonia 27.5% | median 15.2% | 1.5% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Glassia | brand | 2,273 | 267 | 74.7% |
| Prolastin-C Liquid | brand | 1,300 | 192 | 20.8% |
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 Alpha.1-proteinase inhibitor human reports
How many adverse event reports has FDA received for Alpha.1-proteinase inhibitor human?
590 reports list Alpha.1-proteinase inhibitor human as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 172 of them arrived in the latest 12 months. Another 7 list it only as a concomitant medication.
What reactions are recorded in Alpha.1-proteinase inhibitor human reports?
pneumonia (27.5%), dyspnoea (25.4%), product dose omission issue (23.7%), covid-19 (15.9%) and cough (15.1%). 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 Alpha.1-proteinase inhibitor human was responsible.
How serious are the reports?
90.2% are marked serious by the reporter. Among the outcomes recorded, 17.5% of reports include death and 51.5% 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?
consumer or non-health professional (67.3%), other health professional (21.5%) and physician (9.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Alpha.1-proteinase inhibitor human rising?
172 reports in the 12 months to June 2026, up 24% from 139 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 Alpha.1-proteinase inhibitor human 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 Alpha.1-proteinase inhibitor human?
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 Alpha.1-proteinase inhibitor human as a suspect or interacting product; reports listing it only as a concomitant medication (7) 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.