Pharmacologic class (EPC) · 7 drug pages

Aromatic amino acid: adverse event reports filed with FDA

52,862 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

52,862
reports across the class: 0.3% of all reports; 4,759
reports, 12 months to June 2026: 5,254 in the 12 months before; 64.8%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Aromatic amino acid is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 52,862 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

4,759 reports arrived in the 12 months to June 2026, close to the 5,254 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 64.8% of the class's reports are marked serious, 17.2% record death among the outcomes and 33.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are fall (10.4%), dyskinesia (9.3%) and death (8.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Carbidopa levodopa	generic	20,219	3,602	92.4%	Death
RytaryCarbidopa and levodopa	brand	9,999	75	24.1%	Tremor
DuopaCarbidopa and levodopa	brand	8,483	383	75.9%	Fall
InbrijaLevodopa	brand	5,838	314	17.6%	Cough
SinemetCarbidopa and levodopa	brand	4,492	125	66.2%	Drug ineffective
Carbidopa and levodopa	generic	2,411	128	58.5%	Drug ineffective
Levodopa	generic	1,420	132	92%	Dyskinesia

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Falla fall10.4%5,480
Dyskinesiainvoluntary movements9.3%4,915
Deaththe patient died; cause not stated by this term8.3%4,376
Drug ineffectivethe medicine did not work as expected7.9%4,179
Tremorshaking7%3,705
Parkinson's disease6.1%3,243
Hallucinationseeing or hearing things that are not there5.8%3,057
Device issuea problem with the device5.1%2,721
On and off phenomenon5.1%2,695
Coughcough4.8%2,554
Gait disturbancedifficulty walking4.4%2,352
General physical health deteriorationgeneral decline in health3.8%2,019
Weight decreasedweight loss3.8%2,009
Fatiguetiredness3.7%1,974
Dizzinesslight-headedness or unsteadiness3.7%1,949
Device dislocationthe device moved out of position3.6%1,905
Astheniaweakness or lack of energy3.5%1,831
Malaisegeneral feeling of being unwell3.4%1,801
Nauseafeeling sick3.4%1,786
Freezing phenomenon3.3%1,758
Confusional stateconfusion3.1%1,656
Urinary tract infectionbladder or urinary infection3.1%1,633
Mobility decreasedreduced ability to move about3%1,588
Somnolencedrowsiness2.9%1,529
Stoma site discharge2.9%1,507

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death17.2%9,117

Life-threatening1.3%686

Hospitalisation (initial or prolonged)33.3%17,591

Disability1.3%676

Congenital anomaly0%16

Other serious30.6%16,158

Not serious35.2%18,612

Patient age

Under 20%12

2 to 110.1%66

12 to 170.1%59

18 to 440.9%494

45 to 6410.9%5,776

65 to 7422.2%11,744

75 and over24.8%13,107

Age not given40.9%21,604

Who reported

Physician9.7%5,132

Pharmacist2.2%1,188

Other health professional17.6%9,301

Lawyer0%24

Consumer or non-health professional69.7%36,854

Not given0.7%363

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Aromatic amino acid reports

Which drugs are in the Aromatic amino acid class on this site?

Carbidopa levodopa, Rytary, Duopa, Inbrija, Sinemet and Carbidopa and levodopa and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

52,862 reports through June 2026, 4,759 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

fall (10.4%), dyskinesia (9.3%), death (8.3%), drug ineffective (7.9%) and tremor (7%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.