MedDRA preferred term · a build-up of lactic acid in the blood

Lactic acidosis: adverse event reports recording this term

31,601 reports to FDA record it, 2004–2026; 0.2% of the database.

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.

31,601
reports recording the term: 0.2% of all reports; 2,742
reports, 12 months to June 2026: 2,379 in the 12 months before; 99.6%
marked serious by the reporter: 57.4% across all reports; 22.2%
record death among outcomes, as reported: 9.1% across all reports

31,601 reports in FDA's adverse event database record the MedDRA term "Lactic acidosis" (in plain words, a build-up of lactic acid in the blood): 0.2% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

2,742 reports recorded it in the 12 months to June 2026, up 15% from 2,379 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 99.6% are marked serious, 22.2% include death among the outcomes and 72.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Metformin, Metformin hydrochloride and Metformin hcl. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. 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

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Metformin	Biguanide	12,812	19.3%
Metformin hydrochloride	Biguanide	4,697	19.4%
Metformin hcl	Biguanide	1,660	14.7%
Linezolid	Oxazolidinone antibacterial	899	5%
Amlodipine	Calcium channel blocker	715	1.4%
Furosemide	Loop diuretic	706	1.4%
Glucophage	—	627	9.9%
Metformine	—	568	31.8%
Ramipril	Angiotensin converting enzyme inhibitor	510	1.4%
Janumet	Biguanide	494	4.7%
Ibuprofen	Nonsteroidal anti-inflammatory drug	471	0.6%
Acetaminophen	Nonsteroidal anti-inflammatory drug	371	0.4%
Hydrochlorothiazide	Thiazide diuretic	368	1.6%
Gliclazide	—	352	6.4%
Metgluco	—	339	18.3%
Kardegic	—	328	3.5%
Lisinopril	Angiotensin converting enzyme inhibitor	326	0.7%
Dapagliflozin	Sodium-Glucose cotransporter 2 inhibitor	324	1.5%
Bisoprolol	beta-Adrenergic blocker	316	1.4%
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	287	0.8%
Perindopril	—	273	3.3%
Albuterol	beta2-Adrenergic agonist	255	1.4%
Prednisone	Corticosteroid	248	0.1%
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	248	0.8%
Spironolactone	Aldosterone antagonist	247	1.2%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.2% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Biguanide	19,730	16.9%	4.7%
Nonsteroidal anti-inflammatory drug	1,670	0.3%	0%
Angiotensin converting enzyme inhibitor	1,109	1.1%	0.5%
Oxazolidinone antibacterial	1,004	4.3%	2%
Sodium-Glucose cotransporter 2 inhibitor	984	0.9%	1.2%
Angiotensin 2 receptor blocker	911	0.4%	0.3%
beta-Adrenergic blocker	893	0.6%	0.2%
Loop diuretic	867	1.3%	0.9%
Corticosteroid	810	0.1%	0%
Calcium channel blocker	786	1%	0.4%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.5%165

2 to 110.8%260

12 to 173.1%973

18 to 4411.1%3,522

45 to 6426.3%8,309

65 to 7422%6,952

75 and over19.9%6,273

Age not given16.3%5,147

Patient sex

Female45.8%14,470

Male41.2%13,013

Not given13%4,118

Grey bar: all 20,646,523 reports in the database. 30.9% of these reports give the United States as the country.

Questions about "Lactic acidosis"

What does "Lactic acidosis" mean in an adverse event report?

In plain language: a build-up of lactic acid in the blood. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record lactic acidosis?

31,601 reports through June 2026 (0.2% of all reports), 2,742 of them in the latest 12 months.

Which drugs appear most often in these reports?

Metformin (12,812), Metformin hydrochloride (4,697), Metformin hcl (1,660), Linezolid (899) and Amlodipine (715). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

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."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.