ALENDRONATE SODIUM TABLET

N/A

Manufactured by Marlex Pharmaceuticals, Inc.

45,629 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ALENDRONATE SODIUM TABLET

ALENDRONATE SODIUM TABLET is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Marlex Pharmaceuticals, Inc.. The most commonly reported adverse reactions for ALENDRONATE SODIUM TABLET include FATIGUE, DRUG INEFFECTIVE, PAIN, ARTHRALGIA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALENDRONATE SODIUM TABLET.

Top Adverse Reactions

FATIGUE1,348 reports
DRUG INEFFECTIVE1,248 reports
PAIN1,215 reports
ARTHRALGIA1,212 reports
OFF LABEL USE1,152 reports
FALL1,151 reports
DIARRHOEA1,123 reports
NAUSEA1,087 reports
DYSPNOEA1,047 reports
HEADACHE928 reports
PAIN IN EXTREMITY768 reports
PNEUMONIA768 reports
DIZZINESS765 reports
ASTHENIA719 reports
MALAISE697 reports
RASH689 reports
CONDITION AGGRAVATED625 reports
VOMITING619 reports
DEATH616 reports
PERIPHERAL SWELLING581 reports
PRURITUS569 reports
COUGH557 reports
PYREXIA530 reports
WEIGHT DECREASED520 reports
ALOPECIA514 reports
RHEUMATOID ARTHRITIS511 reports
ABDOMINAL DISCOMFORT487 reports
NASOPHARYNGITIS478 reports
BACK PAIN472 reports
GAIT DISTURBANCE469 reports
HYPERTENSION461 reports
JOINT SWELLING459 reports
WEIGHT INCREASED456 reports
INSOMNIA451 reports
DECREASED APPETITE450 reports
INFUSION RELATED REACTION434 reports
ABDOMINAL PAIN UPPER432 reports
ANXIETY412 reports
HYPERSENSITIVITY406 reports
CONFUSIONAL STATE405 reports
CONSTIPATION400 reports
URINARY TRACT INFECTION397 reports
INFECTION395 reports
ABDOMINAL PAIN392 reports
DRUG HYPERSENSITIVITY385 reports
OSTEOPOROSIS375 reports
CONTUSION365 reports
BLOOD PRESSURE INCREASED361 reports
OSTEONECROSIS OF JAW358 reports
PRODUCT DOSE OMISSION ISSUE357 reports
MUSCULAR WEAKNESS354 reports
ARTHROPATHY352 reports
SWELLING349 reports
DEPRESSION347 reports
FEMUR FRACTURE337 reports
HYPOAESTHESIA333 reports
MUSCULOSKELETAL STIFFNESS318 reports
DRUG INTOLERANCE316 reports
SINUSITIS309 reports
CHRONIC KIDNEY DISEASE307 reports
HEPATIC ENZYME INCREASED307 reports
PRODUCT USE ISSUE307 reports
ASTHMA305 reports
ACUTE KIDNEY INJURY300 reports
MUSCLE SPASMS299 reports
MYALGIA299 reports
MOBILITY DECREASED296 reports
GENERAL PHYSICAL HEALTH DETERIORATION294 reports
CHEST PAIN293 reports
GASTROINTESTINAL DISORDER284 reports
SOMNOLENCE283 reports
SYSTEMIC LUPUS ERYTHEMATOSUS283 reports
PRODUCT USE IN UNAPPROVED INDICATION282 reports
INTENTIONAL PRODUCT USE ISSUE276 reports
ATYPICAL FEMUR FRACTURE274 reports
IMPAIRED HEALING274 reports
MEMORY IMPAIRMENT271 reports
WOUND265 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES263 reports
BLISTER260 reports
SYNOVITIS260 reports
OSTEOARTHRITIS258 reports
LOWER RESPIRATORY TRACT INFECTION255 reports
DYSPEPSIA254 reports
GASTROOESOPHAGEAL REFLUX DISEASE254 reports
GLOSSODYNIA254 reports
DRUG DOSE OMISSION253 reports
INFLUENZA253 reports
STOMATITIS253 reports
PEMPHIGUS249 reports
WHEEZING249 reports
PERICARDITIS248 reports
ARTHRITIS245 reports
THERAPEUTIC PRODUCT EFFECT DECREASED245 reports
DISCOMFORT244 reports
URTICARIA243 reports
HAND DEFORMITY241 reports
RENAL FAILURE241 reports
INFLAMMATION240 reports
ILL DEFINED DISORDER237 reports

Report Outcomes

Out of 17,743 classified reports for ALENDRONATE SODIUM TABLET:

Serious 71.1%Non-Serious 28.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female12,251 (78.4%)
Male3,324 (21.3%)
Unknown47 (0.3%)

Reports by Age

Age 68434 reports
Age 70425 reports
Age 72409 reports
Age 67395 reports
Age 69395 reports
Age 66389 reports
Age 71381 reports
Age 73380 reports
Age 74367 reports
Age 64352 reports
Age 65352 reports
Age 75345 reports
Age 62331 reports
Age 63322 reports
Age 59309 reports
Age 78309 reports
Age 76308 reports
Age 77307 reports
Age 61302 reports
Age 79299 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ALENDRONATE SODIUM TABLET?

This profile reflects 45,629 FDA FAERS reports that mention ALENDRONATE SODIUM TABLET. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALENDRONATE SODIUM TABLET?

Frequently reported terms in FAERS include FATIGUE, DRUG INEFFECTIVE, PAIN, ARTHRALGIA, OFF LABEL USE, FALL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALENDRONATE SODIUM TABLET?

Labeling and FAERS entries often list Marlex Pharmaceuticals, Inc. in connection with ALENDRONATE SODIUM TABLET. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.