Levodopa adverse event reports that FDA received

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

Name type: Generic name
Class: Aromatic amino acid

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 2004 to June 2026, FDA received 1,420 adverse event reports that name Levodopa. In these reports the drug is a suspect or interacting product.

In the same period, 4,234 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 132 reports in the 12 months to June 2026 and 69 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, 132 (under 0.1%) name Levodopa. Reports from consumers or other non-health professionals were 15.8% of the reports that name Levodopa 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 Levodopa 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 53 reports that name Levodopa.
In January to March 2026, FDA received 41.
In April to June 2025, FDA received 24.

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 259 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 1,401 of the 1,420 reports (98.7%).

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 259 terms.

Reaction terms in the reports that name Levodopa, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,420 reports
Dyskinesiainvoluntary movements	178	12.5%
Drug ineffectivethe medicine did not work as expected	147	10.4%
Drug interactionan interaction between medicines	101	7.1%
Dopamine dysregulation syndrome	77	5.4%
Parkinson's disease	75	5.3%
Off label useused for a purpose or in a way not on the label	72	5.1%
Falla fall	69	4.9%
Hallucination, visual	67	4.7%
Tremorshaking	66	4.6%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	64	4.5%
On and off phenomenon	63	4.4%
Hallucinationseeing or hearing things that are not there	58	4.1%
Impulse-control disorder	57	4%
Condition aggravatedthe condition being treated got worse	53	3.7%
Anxiety	49	3.5%
Somnolencedrowsiness	49	3.5%
Fatiguetiredness	45	3.2%
Nauseafeeling sick	44	3.1%
Gait disturbancedifficulty walking	42	3%
Muscle rigidity	42	3%
Depressionlow mood	40	2.8%
Deliriumsudden confusion	38	2.7%
Dystoniainvoluntary muscle contractions	38	2.7%
Dizzinesslight-headedness or unsteadiness	36	2.5%
Hypotensionlow blood pressure	34	2.4%
Drug abusemisuse of a medicine	32	2.3%
Pathological gambling	32	2.3%
Dementia	31	2.2%
Drug ineffective for unapproved indication	29	2%
Hypersexuality	29	2%
Orthostatic hypotension	28	2%
Parkinson's disease psychosis	28	2%
Balance disorderproblems with balance	27	1.9%
General physical health deteriorationgeneral decline in health	27	1.9%
Memory impairmentmemory problems	27	1.9%
Painpain, site not specified	27	1.9%
White blood cell count increased	26	1.8%
Astheniaweakness or lack of energy	25	1.8%
Constipation	25	1.8%
Dyspnoeashortness of breath	25	1.8%
Ileusthe bowel stopped moving	25	1.8%
Therapeutic response shortened	25	1.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	25	1.8%
Abnormal behaviourunusual behaviour	24	1.7%
Drug withdrawal syndromesymptoms on stopping a medicine	24	1.7%
Vomitingbeing sick	24	1.7%
Withdrawal syndrome	24	1.7%
Abdominal painstomach or belly pain	23	1.6%
Coma	23	1.6%
Parkinsonism	23	1.6%

Download all 259 terms of Levodopa (CSV)

The counts add to more than 1,420 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 Levodopa with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Levodopa (this page)	Generic name	1,420
Inbrija	Brand name	5,838

Sum of the separately reported names: 7,258. 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 Levodopa, 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
2004	11	10	0	1	6	0	0	6	1
2005	8	7	2	0	3	0	0	3	1
2006	12	11	1	1	4	0	0	6	1
2007	17	17	0	2	6	0	0	11	0
2008	21	21	3	1	9	2	0	14	0
2009	26	25	4	0	8	3	0	17	1
2010	48	45	1	0	19	3	0	34	3
2011	27	27	0	1	10	0	0	18	0
2012	29	27	1	0	13	1	0	20	2
2013	51	48	1	0	13	3	1	35	3
2014	78	76	15	2	32	2	0	33	2
2015	76	72	11	0	27	4	0	55	4
2016	35	26	4	0	9	1	0	21	9
2017	77	71	10	18	38	0	1	58	6
2018	139	130	14	14	61	1	0	91	9
2019	146	133	23	20	74	4	0	88	13
2020	102	87	9	2	43	2	0	61	15
2021	94	84	12	0	34	0	0	66	10
2022	101	92	7	1	32	2	0	77	9
2023	72	64	4	1	24	3	0	55	8
2024	64	58	13	4	20	0	0	49	6
2025	82	77	3	3	35	4	0	59	5
2026	104	99	5	8	32	5	0	80	5

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 Levodopa, 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 Levodopa, by the year in which FDA received them
Year	Reports
2004	10
2005	9
2006	12
2007	16
2008	23
2009	28
2010	48
2011	26
2012	34
2013	51
2014	81
2015	86
2016	35
2017	85
2018	164
2019	133
2020	96
2021	94
2022	90
2023	68
2024	64
2025	73
2026	94

Reports that name Levodopa, 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 Levodopa
Age	Reports	Share
Under 2	1	0.1%
2 to 11	18	1.3%
12 to 17	9	0.6%
18 to 44	69	4.9%
45 to 64	355	25%
65 to 74	327	23%
75 and over	321	22.6%
Age not given	320	22.5%

Sex of the patient in the reports that name Levodopa
Sex	Reports	Share
Female	573	40.4%
Male	686	48.3%
Unknown or not given	161	11.3%

Type of reporter in the reports that name Levodopa
Reporter	Reports	Share
Physician	426	30%
Pharmacist	24	1.7%
Other health professional	660	46.5%
Lawyer	1	0.1%
Consumer or non-health professional	224	15.8%
Not given	85	6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 20.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Levodopa record
Indication as recorded (MedDRA)	Reports	Share
Parkinson's disease	537	37.8%
Parkinson's disease	110	7.7%
Parkinsonism	47	3.3%
Restless legs syndrome	29	2%
Dystonia	19	1.3%
Premedication	11	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,420 reports.

Drugs in the same reports

Other drugs that the reports of Levodopa name, in any role, in order of name
Drug	Reports that name the two
Amantadine	170
Carbidopa levodopa	71
Clonazepam	109
Clozapine	81
Entacapone	206
Gabapentin	85
Pramipexole	273
Quetiapine	82
Ropinirole	172
Sertraline	72

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

Inbrija same ingredient
Rytary same class
Duopa same class
Sinemet same class
Crexont same class
Levocetirizine Hydrochloride next in the A to Z list
Levodopa/Carbidopa next in the A to Z list
Levocetirizine dihydrochloride next in the A to Z list
Levofloxacin next in the A to Z list
Levocetirizine next in the A to Z list
Levofloxacin 500 Mg next in the A to Z list
Levocarnitine 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 LevodopaThe 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. Levodopa: adverse event reports that FDA received. https://reportedreactions.com/drug/levodopa/ 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 Levodopa as a suspect or interacting product. The 4,234 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 Levodopa 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 Levodopa?

No. It is a count of what people reported to FDA: 1,420 reports from April 2004 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?

Other health professional (46.5%), physician (30%) and consumer or non-health professional (15.8%). 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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