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FOSAMAX PLUS D

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Fosamax Plus D Adverse Events Reported to the FDA Over Time

How are Fosamax Plus D adverse event reports trending over time?

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

Most Common Fosamax Plus D Adverse Events Reported to the FDA

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

Femur Fracture
920 (3.35%)
Fall
549 (2%)
Osteonecrosis
344 (1.25%)
Low Turnover Osteopathy
308 (1.12%)
Arthralgia
294 (1.07%)
Tooth Disorder
292 (1.06%)
Impaired Healing
273 (1%)
Pain In Extremity
270 (.98%)
Anxiety
238 (.87%)
Osteoarthritis
231 (.84%)
Back Pain
229 (.84%)
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Hypertension
226 (.82%)
Depression
222 (.81%)
Bone Disorder
205 (.75%)
Pain
202 (.74%)
Stress Fracture
195 (.71%)
Osteomyelitis
191 (.7%)
Osteoporosis
190 (.69%)
Dental Caries
168 (.61%)
Arthropathy
160 (.58%)
Anaemia
156 (.57%)
Gastrooesophageal Reflux Disease
154 (.56%)
Bone Density Decreased
149 (.54%)
Nausea
143 (.52%)
Oedema Peripheral
141 (.51%)
Headache
140 (.51%)
Oral Infection
140 (.51%)
Hyperlipidaemia
138 (.5%)
Myalgia
131 (.48%)
Dizziness
129 (.47%)
Dyspnoea
129 (.47%)
Exostosis
128 (.47%)
Intervertebral Disc Degeneration
122 (.44%)
Chest Pain
121 (.44%)
Fatigue
119 (.43%)
Tooth Fracture
119 (.43%)
Adverse Drug Reaction
118 (.43%)
Vitamin D Deficiency
117 (.43%)
Jaw Disorder
115 (.42%)
Abscess
114 (.42%)
Infection
114 (.42%)
Drug Hypersensitivity
113 (.41%)
Muscle Spasms
111 (.4%)
Arthritis
108 (.39%)
Blood Cholesterol Increased
108 (.39%)
Gait Disturbance
107 (.39%)
Foot Fracture
103 (.38%)
Spinal Osteoarthritis
100 (.36%)
Weight Decreased
100 (.36%)
Cough
98 (.36%)
Oral Disorder
98 (.36%)
Atrial Fibrillation
97 (.35%)
Device Failure
94 (.34%)
Toothache
92 (.34%)
Drug Ineffective
91 (.33%)
Vomiting
91 (.33%)
Cataract
90 (.33%)
Urinary Tract Infection
89 (.32%)
Fracture Nonunion
87 (.32%)
Adverse Event
86 (.31%)
Diarrhoea
86 (.31%)
Insomnia
83 (.3%)
Musculoskeletal Pain
82 (.3%)
Constipation
78 (.28%)
Palpitations
76 (.28%)
Cellulitis
74 (.27%)
Hypercholesterolaemia
73 (.27%)
Hip Fracture
72 (.26%)
Rheumatoid Arthritis
72 (.26%)
Asthenia
71 (.26%)
Dysphagia
71 (.26%)
Osteopenia
71 (.26%)
Paraesthesia
71 (.26%)
Hypoaesthesia
70 (.26%)
Pain In Jaw
70 (.26%)
Gastrointestinal Disorder
69 (.25%)
Rib Fracture
69 (.25%)
Chronic Obstructive Pulmonary Disea...
68 (.25%)
Pyrexia
68 (.25%)
Resorption Bone Increased
68 (.25%)
Bronchitis
67 (.24%)
Contusion
66 (.24%)
Bone Pain
65 (.24%)
Cerebrovascular Accident
65 (.24%)
Bursitis
64 (.23%)
Carpal Tunnel Syndrome
64 (.23%)
Muscular Weakness
64 (.23%)
Scoliosis
64 (.23%)
Fracture Delayed Union
63 (.23%)
Tooth Infection
63 (.23%)
Stomatitis
62 (.23%)
Tooth Loss
62 (.23%)
Neck Pain
61 (.22%)
Migraine
59 (.22%)
Malaise
58 (.21%)
Muscle Strain
56 (.2%)
Rotator Cuff Syndrome
55 (.2%)
Sinusitis
55 (.2%)
Haemoglobin Decreased
52 (.19%)
Haemorrhoids
52 (.19%)
Wrist Fracture
52 (.19%)

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This graph shows the top adverse events submitted to the FDA for Fosamax Plus D, 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 Plus D 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 Plus D

What are the most common Fosamax Plus D 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 Plus D, 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 Plus D 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 Plus D According to Those Reporting Adverse Events

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

Osteoporosis
2970
Osteopenia
1126
Product Used For Unknown Indication
236
Osteoporosis Prophylaxis
220
Drug Use For Unknown Indication
198
Prophylaxis
88
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Bone Density Decreased
52
Osteoarthritis
50
Osteoporosis Postmenopausal
46
Bone Disorder
29
Rheumatoid Arthritis
19
Systemic Lupus Erythematosus
18
Arthritis
11
Osteoporotic Fracture
11
Osteopetrosis
11
Spinal Fracture
10
Resorption Bone Increased
9
Bone Loss
9
Vitamin D Deficiency
8
Postmenopause
8
Menopause
6
Hysterectomy
6
Spinal Compression Fracture
6
Ill-defined Disorder
5
Hip Fracture
4
Spinal Column Stenosis
4
Breast Cancer
4
Hypertension
4
Temporal Arteritis
4
Osteonecrosis
3
Fracture
3
Osteogenesis Imperfecta
3
Femur Fracture
3
Bone Density Abnormal
2
Osteomalacia
2
Neuropathy Peripheral
2
Glaucoma
2
Rib Fracture
2
Bone Decalcification
2
Polymyalgia Rheumatica
2
Cardiovascular Event Prophylaxis
2
Bone Density Increased
2
Sarcoidosis
2
Arthralgia
2
Bone Pain
2
Bone Lesion
1
Cushings Syndrome
1
Osteolysis
1
Bone Scan
1
Compression Fracture
1
Crohns Disease
1

Drug Labels

LabelLabelerEffective
Fosamax Plus DPhysicians Total Care, Inc.20-DEC-11
Fosamax Plus DMerck Sharp & Dohme Corp.29-FEB-12
Fosamax Plus DMerck Sharp & Dohme Corp.19-APR-13

Fosamax Plus D Case Reports

What Fosamax Plus D 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 Plus D. 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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