PatientsVille.com Logo

Actonel Side Effects

PatientsVille

Common Actonel Side Effects


The most commonly reported Actonel side effects (click to view or check a box to report):

Arthralgia (459)
Femur Fracture (299)
Pain In Extremity (276)
Fall (267)
Bone Pain (225)
Myalgia (207)
Pain (201)
Back Pain (196)
Stress Fracture (154)
Diarrhoea (151)
Nausea (140)
Headache (139)
Bone Disorder (134)
Chest Pain (128)
Gait Disturbance (124)
Abdominal Pain Upper (120)
Osteonecrosis (111)
Fatigue (109)
Chills (108)
Dizziness (101)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Actonel Side Effects Reported to FDA



Actonel Side Effect Report#9999123
Headache, Migraine, Migraine With Aura
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Actonel 35mg Warner Chilcott (dosage: NA, start time:
Jan 25, 2014), combined with: NA. and developed a serious reaction and side effect(s): Headache, Migraine, Migraine With Aura after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel 35mg Warner Chilcott treatment in female patients, resulting in Headache side effect.
Actonel Side Effect Report#9988741
Femur Fracture, Comminuted Fracture, Fracture Displacement, Injury, Stress Fracture, Pain In Extremity
This report suggests a potential Actonel Femur Fracture side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Actonel (dosage: NA) starting
Nov 18, 2003. After starting Actonel the patient began experiencing various side effects, including: Femur Fracture, Comminuted Fracture, Fracture Displacement, Injury, Stress Fracture, Pain In ExtremityAdditional drugs used concurrently:
  • Fosamax (alendronate Sodium)
  • Benicar (olmesartan Medoxomil)
  • Lipitor (atorvastatin Calcium)
  • Meloxicam (meloxicam)
  • Prevacid (lansoprazole)
  • Omeprazole (omeprazole)
  • Ambien (zolpidem Tartrate)
  • Alprazolam (alprazolam)
The patient was hospitalized. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Femur Fracture, may still occur.
Actonel Side Effect Report#9988710
Stress Fracture, Pain In Extremity, Osteoporosis, Condition Aggravated
This Stress Fracture problem was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteopenia. On 2007 this consumer started treatment with Actonel (risedronate Sodium) Tablet, 35 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin (acetylsalicylic Acid)
  • Cyanocobalmin (cyanocobalmin)
  • Glucosamine (glucosamine)
  • Multivitamin /01229101/vitamin Nos)
  • Calcium With Vitamin D /00944201/calcium Carbonate, Colecalciferol)
When using Actonel (risedronate Sodium) Tablet, 35 Mg, the patient experienced the following unwanted symptoms/side effects: Stress Fracture, Pain In Extremity, Osteoporosis, Condition AggravatedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stress Fracture, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9932308
Femur Fracture, Arthropathy
This Femur Fracture side effect was reported by a consumer or non-health professional from JP. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Actonel (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Corticosteroid Nos
.After starting to take Actonel the consumer reported adverse symptoms, such as: Femur Fracture, ArthropathyThese side effects may potentially be related to Actonel.
Actonel Side Effect Report#9915712
Pelvic Fracture, Fracture Delayed Union, Gait Disturbance, Groin Pain
This is a report of a 74-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteopenia, who was treated with Actonel (dosage: NA, start time:
Apr 13, 2013), combined with:
  • Lisinopril
  • Atorvastatin
  • Levothyroxine
  • Caltrate D
  • Centrum Silver
  • 81 Mg Aspirin
and developed a serious reaction and side effect(s): Pelvic Fracture, Fracture Delayed Union, Gait Disturbance, Groin Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Pelvic Fracture side effect.
Actonel Side Effect Report#9913564
Femur Fracture, Fall, Fracture Displacement, Bone Disorder, Low Turnover Osteopathy, Stress Fracture, Hyperparathyroidism
This report suggests a potential Actonel Femur Fracture side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Actonel (dosage: NA) starting
Dec 27, 2006. After starting Actonel the patient began experiencing various side effects, including: Femur Fracture, Fall, Fracture Displacement, Bone Disorder, Low Turnover Osteopathy, Stress Fracture, HyperparathyroidismAdditional drugs used concurrently: NA.The patient was hospitalized. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Femur Fracture, may still occur.
Actonel Side Effect Report#9869848
Salmonella Sepsis, Aortic Aneurysm
This Salmonella Sepsis problem was reported by a health professional from AU. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 19, 2013 this consumer started treatment with Actonel (dosage: NA). The following drugs were being taken at the same time:
  • Caltrate
  • Cartia (acetylsalicylic Acid)
  • Coplavix
  • Crestor (rosuvastatin Calcium)
  • Fish Oil (fish Oil) (1 Does From Daily)
  • Humira (1 Times/2 Week)
  • Metoprolol (metoprolol)
  • Panamax
When using Actonel, the patient experienced the following unwanted symptoms/side effects: Salmonella Sepsis, Aortic AneurysmAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Salmonella Sepsis, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9869750
Stress Fracture, Femur Fracture, Arthralgia, Pathological Fracture, Skeletal Injury, Low Turnover Osteopathy, Pain
This Stress Fracture side effect was reported by a consumer or non-health professional from US. A 83-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Actonel (risedronate Sodium) Tablet, 150mg (drug dosage: NA), which was initiated on
Jul 15, 2010. Concurrently used drugs:
  • Fosamax (alendronate Sodium)
  • Boniva (ibandronate Sodium)
  • Reclast
  • Fosamax D
  • Alendronate Sodium (alendronate Sodium) (alendronate Sodium)
  • Ibandronate Sodium
.After starting to take Actonel (risedronate Sodium) Tablet, 150mg the consumer reported adverse symptoms, such as: Stress Fracture, Femur Fracture, Arthralgia, Pathological Fracture, Skeletal Injury, Low Turnover Osteopathy, PainThese side effects may potentially be related to Actonel (risedronate Sodium) Tablet, 150mg. The patient was hospitalized.
Actonel Side Effect Report#9857055
Atrial Fibrillation, Bronchopneumopathy, Pleurisy
This is a report of a 91-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Actonel (risedronate Sodium) Tablet, 35mg (dosage: 35 Mg, Once Weekly, Oral, start time: 200810), combined with: NA. and developed a serious reaction and side effect(s): Atrial Fibrillation, Bronchopneumopathy, Pleurisy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel (risedronate Sodium) Tablet, 35mg treatment in female patients, resulting in Atrial Fibrillation side effect. The patient was hospitalized.
Actonel Side Effect Report#9821278
Femur Fracture, Pain In Extremity
This report suggests a potential Actonel Femur Fracture side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteopenia,osteoporosis and used Actonel (dosage: 1 Tablet) starting NS. After starting Actonel the patient began experiencing various side effects, including: Femur Fracture, Pain In ExtremityAdditional drugs used concurrently: NA.The patient was hospitalized. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Femur Fracture, may still occur.
Actonel Side Effect Report#9820899
Asthenia, Dizziness, Dizziness, Nausea, Diarrhoea, Abdominal Pain Upper
This Asthenia problem was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
Jan 10, 2014 this consumer started treatment with Actonel (dosage: Taken By Mouth). The following drugs were being taken at the same time: NA. When using Actonel, the patient experienced the following unwanted symptoms/side effects: Asthenia, Dizziness, Dizziness, Nausea, Diarrhoea, Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Asthenia, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9812980
Lung Disorder, Eosinophilia, C-reactive Protein Increased, Cough, Dyspnoea, Lung Disorder
This Lung Disorder side effect was reported by a consumer or non-health professional from US. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Actonel (drug dosage: NA), which was initiated on
Jan 04, 2013. Concurrently used drugs:
  • Previscan (fluidione), 20mg
  • Femara (letrozole)
  • Arixtra (fondaparinux Sodium)
.After starting to take Actonel the consumer reported adverse symptoms, such as: Lung Disorder, Eosinophilia, C-reactive Protein Increased, Cough, Dyspnoea, Lung DisorderThese side effects may potentially be related to Actonel.
Actonel Side Effect Report#9808323
Rectal Haemorrhage, Abdominal Pain, Vomiting, Diarrhoea
This is a report of a 56-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Actonel (risedronate Sodium) Tablet, 150 Mg (dosage: 150 Mg Once Monthly, Oral, start time: 201310), combined with:
  • Prilosec /00661201/ {omeprazole}
  • Vitamin D /00318501/ {colecalciferol}
  • Estradiol {estradiol}
  • Iron {iron}
and developed a serious reaction and side effect(s): Rectal Haemorrhage, Abdominal Pain, Vomiting, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel (risedronate Sodium) Tablet, 150 Mg treatment in female patients, resulting in Rectal Haemorrhage side effect. The patient was hospitalized.
Actonel Side Effect Report#9807926
Atypical Pneumonia, Palpitations, Cardiomegaly
This report suggests a potential Actonel Atypical Pneumonia side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: osteoporosis and used Actonel (dosage: Once Monthly) starting 201305. After starting Actonel the patient began experiencing various side effects, including: Atypical Pneumonia, Palpitations, CardiomegalyAdditional drugs used concurrently:
  • Warfarin Potassium (warfarin Potassium)
The patient was hospitalized. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atypical Pneumonia, may still occur.
Actonel Side Effect Report#9789952
Movement Disorder, Blepharospasm
This Movement Disorder problem was reported by a health professional from ES. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
Apr 01, 2000 this consumer started treatment with Actonel (dosage: 35 Mg Once Weekly, Oral). The following drugs were being taken at the same time: NA. When using Actonel, the patient experienced the following unwanted symptoms/side effects: Movement Disorder, BlepharospasmAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Movement Disorder, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9789945
Atypical Fracture, Pain In Extremity, Pain In Extremity
This Atypical Fracture side effect was reported by a physician from JP. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Actonel (drug dosage: NA), which was initiated on
Mar 15, 2011. Concurrently used drugs: NA..After starting to take Actonel the consumer reported adverse symptoms, such as: Atypical Fracture, Pain In Extremity, Pain In ExtremityThese side effects may potentially be related to Actonel.
Actonel Side Effect Report#9785885
Constipation, Muscular Weakness, Myalgia, Rash Macular, Skin Lesion, Vomiting, Blood Potassium Decreased, Decreased Appetite, Body Temperature Increased
This is a report of a 57-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Actonel (dosage: 150 Mg Once Monthly, Oral, start time:
Nov 08, 2013), combined with:
  • Oscal D/00944201/calcium Carbonate, Colecalciferol)
and developed a serious reaction and side effect(s): Constipation, Muscular Weakness, Myalgia, Rash Macular, Skin Lesion, Vomiting, Blood Potassium Decreased, Decreased Appetite, Body Temperature Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Constipation side effect. The patient was hospitalized.
Actonel Side Effect Report#9783626
Chills, Body Temperature Increased, Vomiting
This report suggests a potential Actonel (risedronate Sodium) Tablet, 150mg Chills side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: NA and used Actonel (risedronate Sodium) Tablet, 150mg (dosage: NA) starting
Jul 05, 2012. After starting Actonel (risedronate Sodium) Tablet, 150mg the patient began experiencing various side effects, including: Chills, Body Temperature Increased, VomitingAdditional drugs used concurrently:
  • Vitamin D
  • Caltrate /00751519/ (calcium Carbonate
  • Prolia (denosumab)
The patient was hospitalized. Although Actonel (risedronate Sodium) Tablet, 150mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chills, may still occur.
Actonel Side Effect Report#9761254
Miliaria, Convulsion, Miliaria
This Miliaria problem was reported by a consumer or non-health professional from AU. A 75-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 08, 2011 this consumer started treatment with Actonel (dosage: 150 Mg Once Monthly, Oral). The following drugs were being taken at the same time:
  • Warfarin ( Warfarin)
When using Actonel, the patient experienced the following unwanted symptoms/side effects: Miliaria, Convulsion, MiliariaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Miliaria, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9761203
Depressed Level Of Consciousness, Confusional State, Suicide Attempt, Depressed Level Of Consciousness
This Depressed Level Of Consciousness side effect was reported by a health professional from IT. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: suicide attempt.The patient was prescribed Actonel (risedronate Sodium) Tablet, Unkmg (drug dosage: 3 Dose Forms Total, Oral), which was initiated on
Nov 08, 2013. Concurrently used drugs:
  • Patrol (paracetamol, Tramadol Hydochloride) 325/37.5mg? (7 Dose Froms Total, Oral)
  • Palexia (9 Dose Forms Total, Oral)
  • Acetamol /00020001/ (paracetamol) 500 Mg (4 Dose Forms Total, Oral)
  • Gabapentin (gabapentin) (14 Dose Forms Total, Oral)
  • Homeopathic Preparation
  • Homeopathic Preparation
.After starting to take Actonel (risedronate Sodium) Tablet, Unkmg the consumer reported adverse symptoms, such as: Depressed Level Of Consciousness, Confusional State, Suicide Attempt, Depressed Level Of ConsciousnessThese side effects may potentially be related to Actonel (risedronate Sodium) Tablet, Unkmg. The patient was hospitalized.
Actonel Side Effect Report#9747777
Femur Fracture, Fall, Balance Disorder
This is a report of a 58-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: NA, who was treated with Actonel (risedronate Sodium) Tablet (dosage: NA, start time:
Feb 03, 2010), combined with:
  • Rituxan
  • Methotrexate (methotrexate)
  • Celebrex (celecoxib)
  • Folic Acid (folic Acid)
  • Pantoprazole (pantoprazole)
  • Calcium (calcium)
  • Multivitamin
  • Vitamin D
and developed a serious reaction and side effect(s): Femur Fracture, Fall, Balance Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel (risedronate Sodium) Tablet treatment in female patients, resulting in Femur Fracture side effect.
Actonel Side Effect Report#9747768
Hemiparesis, Sensory Disturbance, Oedema Peripheral, Gingivitis, Emotional Distress, Suicidal Ideation, Insomnia, Nightmare, Motor Dysfunction
This report suggests a potential Actonel Hemiparesis side effect(s) that can have serious consequences. A female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: osteoporosis and used Actonel (dosage: 2 Cd/month) starting
Oct 01, 2013. After starting Actonel the patient began experiencing various side effects, including: Hemiparesis, Sensory Disturbance, Oedema Peripheral, Gingivitis, Emotional Distress, Suicidal Ideation, Insomnia, Nightmare, Motor DysfunctionAdditional drugs used concurrently: NA. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hemiparesis, may still occur.
Actonel Side Effect Report#9702703
Hepatic Function Abnormal, Renal Impairment, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Aspartate Aminotransferase Increased, Gamma-glutamyltransferase Increased, Alanine Aminotransferase Increased, Blood Urea Increased, Blood Creatinine Increased
This Hepatic Function Abnormal problem was reported by a health professional from JP. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteitis deformans. On
Sep 29, 2012 this consumer started treatment with Actonel (dosage: NA). The following drugs were being taken at the same time: NA. When using Actonel, the patient experienced the following unwanted symptoms/side effects: Hepatic Function Abnormal, Renal Impairment, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Aspartate Aminotransferase Increased, Gamma-glutamyltransferase Increased, Alanine Aminotransferase Increased, Blood Urea Increased, Blood Creatinine IncreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Function Abnormal, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9693971
Atypical Femur Fracture, Bone Disorder, Pain In Extremity, Pathological Fracture
This Atypical Femur Fracture side effect was reported by a health professional from JP. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Actonel (risedronate Sodium) Tablet, Unkmg (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Actonel (risedronate Sodium) Tablet, Unkmg the consumer reported adverse symptoms, such as: Atypical Femur Fracture, Bone Disorder, Pain In Extremity, Pathological FractureThese side effects may potentially be related to Actonel (risedronate Sodium) Tablet, Unkmg. The patient was hospitalized.
Actonel Side Effect Report#9693855
Low Turnover Osteopathy, Atypical Femur Fracture, Fall
This is a report of a 74-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: spinal compression fracture, who was treated with Actonel (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Low Turnover Osteopathy, Atypical Femur Fracture, Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Low Turnover Osteopathy side effect. The patient was hospitalized.


1 of 109 


The appearance of Actonel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Actonel Side Effects for Women?

Women Side EffectsReports
Arthralgia 436
Femur Fracture 290
Pain In Extremity 272
Fall 256
Bone Pain 221
Myalgia 200
Back Pain 191
Pain 190
Stress Fracture 151
Diarrhoea 140

What are common Actonel Side Effects for Men?

Men Side EffectsReports
Arthralgia 22
Dizziness 13
Diarrhoea 11
Dyspnoea 11
Fall 11
Pain 11
Pain In Jaw 9
Femur Fracture 8
Oedema Peripheral 8
Osteonecrosis 8

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Actonel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Actonel Side Effects

    Did You Have a Actonel Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Actonel for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Actonel Safety Alerts, Active Ingredients, Usage Information

    NDC0149-0470
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameACTONEL
    NameRISEDRONATE SODIUM
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19980327
    LabelerWarner Chilcott Pharmaceuticals Inc.
    Active Ingredient(s)RISEDRONATE SODIUM
    Strength(s)30
    Unit(s)mg/1
    Pharma ClassBisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]

    Actonel Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2712

    Actonel safety alerts: 2008 2007

    Reported deaths: 85

    Reported hospitalizations: 1116

    Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

    Audience: Pharmacists, other healthcare professionals

    [Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

    Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

    [January 07, 2008 - Drug Information page - FDA]

    Latest Actonel clinical trials