Alendronate (alendronate sodium tablet) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Alendronate sodium tablet
Class: Bisphosphonate
Also reported as: Alendronate 70mg, Alendronate Tablet, Alendronate 70

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 February 2005 to June 2026, FDA received 4,045 adverse event reports that name Alendronate. In these reports the drug is a suspect or interacting product.

In the same period, 14,657 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 213 reports in the 12 months to June 2026 and 239 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, 213 (under 0.1%) name Alendronate. Reports for male patients were 9.7% of the reports that name Alendronate and 34.6% 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 Alendronate 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 38 reports that name Alendronate.
In January to March 2026, FDA received 37.
In April to June 2025, FDA received 45.

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 605 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 4,001 of the 4,045 reports (98.9%).

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 605 terms.

Reaction terms in the reports that name Alendronate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,045 reports
Arthralgiajoint pain	529	13.1%
Painpain, site not specified	459	11.3%
Drug ineffectivethe medicine did not work as expected	417	10.3%
Fatiguetiredness	372	9.2%
Osteonecrosis of jawdeath of jaw bone tissue	339	8.4%
Dyspnoeashortness of breath	337	8.3%
Pain in extremitypain in an arm or leg	333	8.2%
Abdominal discomfortstomach discomfort	319	7.9%
Rashskin rash	303	7.5%
Diarrhoealoose or frequent stools	298	7.4%
Nauseafeeling sick	292	7.2%
Off label useused for a purpose or in a way not on the label	291	7.2%
Femur fracture	287	7.1%
Condition aggravatedthe condition being treated got worse	283	7%
Joint swellinga swollen joint	280	6.9%
Alopeciahair loss	278	6.9%
Headachehead pain	278	6.9%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	275	6.8%
Hypersensitivityan allergic-type reaction	269	6.7%
Infusion related reactiona reaction during or soon after an infusion	267	6.6%
Atypical femur fracture	261	6.5%
Malaisegeneral feeling of being unwell	259	6.4%
Peripheral swellingswelling of the arms or legs	259	6.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	258	6.4%
Falla fall	258	6.4%
Arthropathy	256	6.3%
Drug intolerancethe medicine was not tolerated	247	6.1%
Systemic lupus erythematosuslupus, an autoimmune disease	244	6%
Pemphigus	233	5.8%
Swelling	233	5.8%
Glossodynia	230	5.7%
Impaired healingslow healing	228	5.6%
Synovitis	228	5.6%
Pericarditisinflammation of the sac around the heart	225	5.6%
Hand deformity	224	5.5%
Hepatic enzyme increasedraised liver enzymes	221	5.5%
Pruritusitching	220	5.4%
Dizzinesslight-headedness or unsteadiness	218	5.4%
Hypertensionhigh blood pressure	218	5.4%
Gastrointestinal disorder	216	5.3%
Abdominal pain upperupper stomach pain	211	5.2%
Anti-cyclic citrullinated peptide antibody positive	205	5.1%
Contraindicated product administered	205	5.1%
Therapeutic product effect decreased	204	5%
Musculoskeletal stiffnessstiffness in muscles or joints	200	4.9%
Wound	199	4.9%
Duodenal ulcer perforation	197	4.9%
Infectionan infection, type not specified	192	4.7%
Product use issuea problem in how the product was used	192	4.7%
Blistera blister	189	4.7%

Download all 605 terms of Alendronate (CSV)

The counts add to more than 4,045 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 Alendronate sodium with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Alendronate sodium	Generic name	18,082
Alendronate (this page)	Brand name	4,045
Fosamax	Brand name	34,844

Sum of the separately reported names: 56,971. 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 Alendronate, 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	0	0	0	0	0	0	0	0	0
2005	8	7	1	1	6	0	0	2	1
2006	0	0	0	0	0	0	0	0	0
2008	5	5	0	0	3	0	0	2	0
2009	14	13	2	0	1	2	0	9	1
2010	21	18	0	2	2	4	0	15	3
2011	13	12	0	2	3	0	0	9	1
2012	41	40	2	1	14	5	0	30	1
2013	144	138	1	7	60	25	0	95	6
2014	201	185	7	0	59	26	1	140	16
2015	271	259	4	14	71	23	0	198	12
2016	257	207	6	3	70	18	0	145	50
2017	283	206	17	4	69	14	0	156	77
2018	360	257	8	1	72	22	1	209	103
2019	455	351	9	6	123	22	5	265	104
2020	381	285	12	8	135	31	4	190	96
2021	380	307	3	10	113	38	0	245	73
2022	272	197	11	24	77	54	1	174	75
2023	241	175	29	29	78	38	15	157	66
2024	280	219	82	67	135	79	38	191	61
2025	290	227	78	66	103	72	35	200	63
2026	128	112	39	34	65	38	21	96	16

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 Alendronate, 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 Alendronate, by the year in which FDA received them
Year	Reports
2005	8
2008	5
2009	15
2010	12
2011	30
2012	59
2013	150
2014	204
2015	277
2016	270
2017	309
2018	390
2019	477
2020	394
2021	392
2022	234
2023	247
2024	266
2025	231
2026	75

Reports that name Alendronate, 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 Alendronate
Age	Reports	Share
Under 2	7	0.2%
2 to 11	6	0.1%
12 to 17	14	0.3%
18 to 44	253	6.3%
45 to 64	764	18.9%
65 to 74	616	15.2%
75 and over	723	17.9%
Age not given	1,662	41.1%

Sex of the patient in the reports that name Alendronate
Sex	Reports	Share
Female	2,438	60.3%
Male	392	9.7%
Unknown or not given	1,215	30%

Type of reporter in the reports that name Alendronate
Reporter	Reports	Share
Physician	857	21.2%
Pharmacist	233	5.8%
Other health professional	1,533	37.9%
Lawyer	41	1%
Consumer or non-health professional	1,237	30.6%
Not given	144	3.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 40.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Alendronate record
Indication as recorded (MedDRA)	Reports	Share
Osteoporosis	1,421	35.1%
Rheumatoid arthritis	267	6.6%
Osteopenia	115	2.8%
Osteoporosis prophylaxis	84	2.1%
Bone disorder	74	1.8%
Osteoporosis postmenopausal	71	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,045 reports.

Drugs in the same reports

Other drugs that the reports of Alendronate name, in any role, in order of name
Drug	Reports that name the two
Enbrel	408
Folic acid	477
Fosamax	442
Humira	383
Hydroxychloroquine	366
Leflunomide	371
Methotrexate	524
Orencia	375
Prednisone	710
Sulfasalazine	420

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

Alendronate sodium same ingredient
Fosamax same ingredient
Actonel same class
Atelvia same class
Alemtuzumab next in the A to Z list
Alectinib next in the A to Z list
Alendronate Sodium Cholecalciferol next in the A to Z list
Alecensa next in the A to Z list
Alendronic Acid next in the A to Z list
Aldurazyme next in the A to Z list
Alendronic Acid Tablets next in the A to Z list
Aldomet 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 AlendronateThe 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. Alendronate: adverse event reports that FDA received. https://reportedreactions.com/drug/alendronate/ 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 Alendronate as a suspect or interacting product. The 14,657 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 Alendronate 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 Alendronate?

No. It is a count of what people reported to FDA: 4,045 reports from February 2005 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 (37.9%), consumer or non-health professional (30.6%) and physician (21.2%). 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.

To the top of the page