Inbrija: adverse event reports filed with FDA

5,838

reports as suspect product

0% of all reports · about 668 a year

314

reports, 12 months to June 2026

150 in the 12 months before

17.6%

marked serious by the reporter

64.8% across the class

8.6%

record death among outcomes, as reported

501 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 Inbrija reports recording the termmedian drug in aromatic amino acid

1. Coughcough38%2,216
2. Drug ineffectivethe medicine did not work as expected16.4%958
3. Parkinson's disease12.6%734
4. Device issuea problem with the device10.2%595
5. Product residue present9.6%559
6. Device difficult to usethe device was hard to use8.3%487
7. Device use issue7.7%449
8. Condition aggravatedthe condition being treated got worse7.5%437
9. Deaththe patient died; cause not stated by this term6.6%387
10. Therapeutic product effect variable5.1%296
11. Dyskinesiainvoluntary movements5.1%295
12. Wrong technique in device usage process4.6%271
13. Device occlusionthe device blocked4%232
14. Dyspnoeashortness of breath3.9%229
15. Chokingchoking3.9%228
16. Tremorshaking3.8%223
17. Sputum discoloured3.8%219
18. Wrong technique in product usage processthe product was used in the wrong way3.6%213
19. Intentional underdose3.4%201
20. Throat irritationan irritated throat3.4%200
21. Inappropriate schedule of product administrationthe product was taken at the wrong times3.4%197
22. Falla fall3.3%193
23. Hallucinationseeing or hearing things that are not there3.2%187
24. Dizzinesslight-headedness or unsteadiness3.2%184
25. Incorrect dose administered by devicethe device gave the wrong dose2.8%166
26. Incorrect dose administeredthe wrong dose was given2.6%154
27. Fatiguetiredness2.6%153
28. Ill-defined disordera condition that was not clearly described2.6%152
29. Nauseafeeling sick2.6%149
30. Adverse eventan unwanted medical event, type not specified2.4%138

Top 30 of 481 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 7 drugs in the aromatic amino acid 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 52,862 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. 99.1% 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 5,838 reports.

Drugs most often listed in the same reports

Other products listed in reports where Inbrija 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 aromatic amino acid 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 Inbrija as a suspect or interacting product; reports listing it only as a concomitant medication (686) 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.