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Fosamax Adverse Events Reported to the FDA Over Time

How are Fosamax adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Fosamax, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Fosamax is flagged as the suspect drug causing the adverse event.

Most Common Fosamax Adverse Events Reported to the FDA

What are the most common Fosamax adverse events reported to the FDA?

Femur Fracture
10523 (4.44%)
Osteonecrosis
5377 (2.27%)
Fall
4277 (1.81%)
Low Turnover Osteopathy
3761 (1.59%)
Anxiety
2390 (1.01%)
Osteomyelitis
2271 (.96%)
Impaired Healing
2208 (.93%)
Arthralgia
2166 (.91%)
Tooth Disorder
2062 (.87%)
Depression
2060 (.87%)
Osteoarthritis
2027 (.86%)
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Hypertension
1935 (.82%)
Osteoporosis
1930 (.81%)
Pain In Extremity
1923 (.81%)
Stress Fracture
1892 (.8%)
Pain
1743 (.74%)
Bone Disorder
1664 (.7%)
Back Pain
1592 (.67%)
Gastrooesophageal Reflux Disease
1475 (.62%)
Anaemia
1360 (.57%)
Dental Caries
1328 (.56%)
Arthropathy
1301 (.55%)
Jaw Disorder
1292 (.55%)
Nausea
1163 (.49%)
Hyperlipidaemia
1127 (.48%)
Bone Density Decreased
1117 (.47%)
Oral Infection
1116 (.47%)
Oedema Peripheral
1070 (.45%)
Death
1055 (.45%)
Fatigue
1023 (.43%)
Chest Pain
1005 (.42%)
Headache
994 (.42%)
Dizziness
985 (.42%)
Blood Cholesterol Increased
954 (.4%)
Diarrhoea
954 (.4%)
Exostosis
903 (.38%)
Constipation
902 (.38%)
Adverse Drug Reaction
886 (.37%)
Foot Fracture
849 (.36%)
Insomnia
848 (.36%)
Urinary Tract Infection
842 (.36%)
Adverse Event
824 (.35%)
Myalgia
823 (.35%)
Infection
813 (.34%)
Hip Fracture
812 (.34%)
Arthritis
809 (.34%)
Tooth Fracture
806 (.34%)
Dyspnoea
791 (.33%)
Gait Disturbance
791 (.33%)
Intervertebral Disc Degeneration
774 (.33%)
Spinal Osteoarthritis
772 (.33%)
Cataract
769 (.32%)
Drug Hypersensitivity
767 (.32%)
Vitamin D Deficiency
755 (.32%)
Pain In Jaw
747 (.32%)
Abscess
736 (.31%)
Chronic Obstructive Pulmonary Disea...
730 (.31%)
Weight Decreased
723 (.31%)
Muscle Spasms
715 (.3%)
Vomiting
692 (.29%)
Oral Disorder
682 (.29%)
Pneumonia
667 (.28%)
Osteopenia
664 (.28%)
Drug Ineffective
662 (.28%)
Cellulitis
655 (.28%)
Bronchitis
654 (.28%)
Device Failure
648 (.27%)
Bursitis
634 (.27%)
Sinusitis
631 (.27%)
Cough
629 (.27%)
Tooth Loss
625 (.26%)
Fracture Nonunion
623 (.26%)
Fracture
617 (.26%)
Temporomandibular Joint Syndrome
617 (.26%)
Asthenia
595 (.25%)
Dysphagia
577 (.24%)
Hypercholesterolaemia
571 (.24%)
Gingival Disorder
569 (.24%)
Dyspepsia
551 (.23%)
Injury
551 (.23%)
Rotator Cuff Syndrome
550 (.23%)
Asthma
548 (.23%)
Toothache
546 (.23%)
Rash
539 (.23%)
Hypothyroidism
536 (.23%)
Haemorrhoids
525 (.22%)
Intervertebral Disc Protrusion
513 (.22%)
Tooth Abscess
502 (.21%)
Rib Fracture
501 (.21%)
Atrial Fibrillation
500 (.21%)
Resorption Bone Increased
493 (.21%)
Gastrointestinal Disorder
492 (.21%)
Gingival Bleeding
488 (.21%)
Hypoaesthesia
484 (.2%)
Carpal Tunnel Syndrome
481 (.2%)
Cerebrovascular Accident
481 (.2%)
Musculoskeletal Pain
481 (.2%)
Muscular Weakness
473 (.2%)
Hypokalaemia
472 (.2%)
Contusion
469 (.2%)
Syncope
469 (.2%)

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This graph shows the top adverse events submitted to the FDA for Fosamax, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Fosamax is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Fosamax

What are the most common Fosamax adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Fosamax, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Fosamax is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Fosamax According to Those Reporting Adverse Events

Why are people taking Fosamax, according to those reporting adverse events to the FDA?

Osteoporosis
25981
Osteopenia
8200
Osteoporosis Prophylaxis
1874
Drug Use For Unknown Indication
1104
Product Used For Unknown Indication
946
Prophylaxis
517
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Bone Density Decreased
455
Bone Disorder
384
Osteoporosis Postmenopausal
243
Osteoarthritis
237
Rheumatoid Arthritis
165
Osteitis Deformans
119
Bone Loss
113
Arthritis
82
Resorption Bone Increased
75
Menopause
60
Hip Fracture
56
Fracture
53
Stress Fracture
52
Osteoporotic Fracture
49
Multiple Myeloma
47
Spinal Compression Fracture
47
Spinal Fracture
47
Breast Cancer
40
Calcium Deficiency
39
Bone Density Abnormal
37
Postmenopause
33
Systemic Lupus Erythematosus
32
Senile Osteoporosis
31
Ill-defined Disorder
29
Osteogenesis Imperfecta
26
Scoliosis
24
Osteonecrosis
22
Hypercalcaemia
19
Jaw Fracture
17
Foot Fracture
17
Wrist Fracture
16
Compression Fracture
16
Hysterectomy
16
Premature Menopause
15
Pain
15
Fibromyalgia
15
Osteosclerosis
14
Back Pain
14
Fractured Sacrum
14
Metastases To Bone
12
Vitamin D Deficiency
12
Osteopetrosis
12
Lower Limb Fracture
12
Hypertension
11
Hip Arthroplasty
11

Drug Labels

LabelLabelerEffective
FosamaxPhysicians Total Care, Inc.05-MAR-10
Fosamax Plus DPhysicians Total Care, Inc.20-DEC-11
Fosamax Plus DMerck Sharp & Dohme Corp.29-FEB-12
FosamaxMerck Sharp & Dohme Corp.27-JUN-12
Fosamax Plus DMerck Sharp & Dohme Corp.19-APR-13
FosamaxMerck Sharp & Dohme Corp.19-APR-13

Fosamax Case Reports

What Fosamax safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Fosamax. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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