Alendronic Acid adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Alendronic Acid /01220302/

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.

Reports on file

From September 2004 to June 2026, FDA received 9,665 adverse event reports that name Alendronic Acid. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 8,737 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,405 reports in the 12 months to June 2026 and 1,746 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Alendronic Acid 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 355 reports that name Alendronic Acid.
In January to March 2026, FDA received 279.
In April to June 2025, FDA received 333.

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 768 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 9,641 of the 9,665 reports (99.8%).

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 768 terms.

Reaction terms in the reports that name Alendronic Acid, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 9,665 reports
Fatiguetiredness	2,733	28.3%
Painpain, site not specified	2,521	26.1%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	2,508	25.9%
Glossodynia	2,507	25.9%
Rashskin rash	2,443	25.3%
Off label useused for a purpose or in a way not on the label	2,430	25.1%
Systemic lupus erythematosuslupus, an autoimmune disease	2,400	24.8%
Alopeciahair loss	2,378	24.6%
Abdominal discomfortstomach discomfort	2,373	24.6%
Arthralgiajoint pain	2,363	24.4%
Hand deformity	2,344	24.3%
Pemphigus	2,266	23.4%
Infusion related reactiona reaction during or soon after an infusion	2,224	23%
Swelling	2,216	22.9%
Wound	2,213	22.9%
Drug ineffectivethe medicine did not work as expected	2,210	22.9%
Joint swellinga swollen joint	2,196	22.7%
Arthropathy	2,164	22.4%
Synovitis	2,140	22.1%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	2,059	21.3%
Pericarditisinflammation of the sac around the heart	2,019	20.9%
Hypersensitivityan allergic-type reaction	1,997	20.7%
Helicobacter infection	1,981	20.5%
Duodenal ulcer perforation	1,980	20.5%
General physical health deteriorationgeneral decline in health	1,974	20.4%
Hepatic enzyme increasedraised liver enzymes	1,961	20.3%
Psoriatic arthropathy	1,942	20.1%
Condition aggravatedthe condition being treated got worse	1,896	19.6%
Drug intolerancethe medicine was not tolerated	1,893	19.6%
Headachehead pain	1,869	19.3%
Contraindicated product administered	1,859	19.2%
Hypertensionhigh blood pressure	1,834	19%
Impaired healingslow healing	1,826	18.9%
Folliculitis	1,815	18.8%
Anti-cyclic citrullinated peptide antibody positive	1,799	18.6%
Irritable bowel syndrome	1,757	18.2%
Vomitingbeing sick	1,757	18.2%
Diarrhoealoose or frequent stools	1,752	18.1%
Fibromyalgia	1,736	18%
Type 2 diabetes mellitustype 2 diabetes	1,719	17.8%
Hypoaesthesianumbness	1,703	17.6%
Musculoskeletal stiffnessstiffness in muscles or joints	1,702	17.6%
Malaisegeneral feeling of being unwell	1,691	17.5%
Blistera blister	1,685	17.4%
Dyspnoeashortness of breath	1,642	17%
Discomfort	1,638	16.9%
Peripheral swellingswelling of the arms or legs	1,637	16.9%
Blood cholesterol increasedraised cholesterol	1,615	16.7%
Weight increasedweight gain	1,611	16.7%
Liver injury	1,593	16.5%

Download all 768 terms of Alendronic Acid (CSV)

The counts add to more than 9,665 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.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Alendronic Acid, 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	1	1	0	0	0	1	0	0	0
2005	11	11	1	2	9	1	0	5	0
2006	6	6	0	0	5	0	0	1	0
2007	6	6	0	1	3	1	0	3	0
2008	63	63	11	10	24	6	0	34	0
2009	186	184	11	21	66	33	0	84	2
2010	179	178	7	18	37	20	13	111	1
2011	134	134	1	10	45	45	0	80	0
2012	185	184	8	2	41	29	2	145	1
2013	325	322	10	18	104	73	1	211	3
2014	348	347	10	18	97	71	25	231	1
2015	339	270	0	11	96	48	0	199	69
2016	378	321	5	9	84	21	3	246	57
2017	164	161	19	4	44	14	0	127	3
2018	255	254	2	16	81	32	0	192	1
2019	346	340	19	2	126	37	5	260	6
2020	273	271	5	4	113	30	5	206	2
2021	430	429	15	29	110	123	0	385	1
2022	688	687	137	106	204	206	1	617	1
2023	770	769	265	290	363	338	41	709	1
2024	1,536	1,536	960	1,018	1,068	1,101	320	1,476	0
2025	1,874	1,874	1,350	1,303	1,331	1,322	726	1,759	0
2026	1,168	1,166	870	776	818	792	593	1,090	2

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 Alendronic Acid, 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 Alendronic Acid, by the year in which FDA received them
Year	Reports
2004	1
2005	12
2006	5
2007	8
2008	62
2009	195
2010	181
2011	125
2012	215
2013	321
2014	350
2015	348
2016	423
2017	155
2018	305
2019	455
2020	349
2021	566
2022	732
2023	870
2024	1,749
2025	1,604
2026	634

Reports that name Alendronic Acid, 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 Alendronic Acid
Age	Reports	Share
Under 2	14	0.1%
2 to 11	2	under 0.1%
12 to 17	4	under 0.1%
18 to 44	2,884	29.8%
45 to 64	1,380	14.3%
65 to 74	1,125	11.6%
75 and over	1,468	15.2%
Age not given	2,788	28.8%

Sex of the patient in the reports that name Alendronic Acid
Sex	Reports	Share
Female	7,349	76%
Male	694	7.2%
Unknown or not given	1,622	16.8%

Type of reporter in the reports that name Alendronic Acid
Reporter	Reports	Share
Physician	1,486	15.4%
Pharmacist	427	4.4%
Other health professional	6,128	63.4%
Lawyer	70	0.7%
Consumer or non-health professional	1,317	13.6%
Not given	237	2.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Alendronic Acid record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	3,586	37.1%
Osteoporosis	1,728	17.9%
Osteoporosis prophylaxis	157	1.6%
Osteoporosis postmenopausal	101	1%
Osteopenia	100	1%
Foetal exposure during pregnancy	91	0.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 9,665 reports.

Drugs in the same reports

Other drugs that the reports of Alendronic Acid name, in any role, in order of name
Drug	Reports that name the two
Cimzia	3,746
Desoximetasone	3,767
Diclofenac sodium	3,986
Enbrel	3,694
Folic acid	4,233
Leflunomide	3,885
Methotrexate	4,377
Prednisone	4,453
Rituximab	4,203
Sulfasalazine	3,977

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

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Alendronic AcidThe 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. Alendronic Acid: adverse event reports that FDA received. https://reportedreactions.com/drug/alendronic-acid/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Alendronic Acid as a suspect or interacting product. The 8,737 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 Alendronic Acid 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 Alendronic Acid?

No. It is a count of what people reported to FDA: 9,665 reports from September 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 (63.4%), physician (15.4%) and consumer or non-health professional (13.6%). 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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