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Actonel Side Effects

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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#9693244
Atypical Femur Fracture, Injury, Bone Disorder
This is a report of a 71-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: NA, who was treated with Actonel (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Atypical Femur Fracture, Injury, Bone Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Atypical Femur Fracture side effect.
Actonel Side Effect Report#9681402
Fall, Femur Fracture, Fracture Displacement, Pain In Extremity, Bone Disorder, Pathological Fracture, Stress Fracture
This report suggests a potential Actonel Fall side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from KR was diagnosed with the following symptoms/conditions: osteoporosis and used Actonel (dosage: 35 Mg, 1/week) starting NS. After starting Actonel the patient began experiencing various side effects, including: Fall, Femur Fracture, Fracture Displacement, Pain In Extremity, Bone Disorder, Pathological Fracture, Stress FractureAdditional drugs used concurrently: NA. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Actonel Side Effect Report#9679174
Femur Fracture, Stress Fracture, Pathological Fracture, Pain In Extremity
This Femur Fracture problem was reported by a health professional from KR. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS 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: Femur Fracture, Stress Fracture, Pathological Fracture, Pain In ExtremityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Femur Fracture, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9679111
Femur Fracture, Pain In Extremity, Stress Fracture, Pathological Fracture, Fall, Bone Disorder
This Femur Fracture side effect was reported by a health professional from KR. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Actonel (risedronate Sodium) Tablet, 35mg (drug dosage: 35 Mg Once Weekly, Oral), which was initiated on NS. Concurrently used drugs: NA..After starting to take Actonel (risedronate Sodium) Tablet, 35mg the consumer reported adverse symptoms, such as: Femur Fracture, Pain In Extremity, Stress Fracture, Pathological Fracture, Fall, Bone DisorderThese side effects may potentially be related to Actonel (risedronate Sodium) Tablet, 35mg.
Actonel Side Effect Report#9669305
Osteomyelitis, Pain In Jaw, Secretion Discharge
This is a report of a 75-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Actonel (dosage: NA, start time: 2006), combined with: NA. and developed a serious reaction and side effect(s): Osteomyelitis, Pain In Jaw, Secretion Discharge after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Osteomyelitis side effect.
Actonel Side Effect Report#9669296
Osteomyelitis, Swelling Face, Trismus, Abscess Jaw, Exposed Bone In Jaw, Dental Fistula, Stomatitis
This report suggests a potential Actonel Osteomyelitis side effect(s) that can have serious consequences. A 88-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: osteoporosis and used Actonel (dosage: NA) starting NS. After starting Actonel the patient began experiencing various side effects, including: Osteomyelitis, Swelling Face, Trismus, Abscess Jaw, Exposed Bone In Jaw, Dental Fistula, StomatitisAdditional drugs used concurrently: NA. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteomyelitis, may still occur.
Actonel Side Effect Report#9669277
Headache, Malaise, Nausea, Diarrhoea
This Headache problem was reported by a health professional from JP. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
Sep 01, 2013 this consumer started treatment with Actonel (dosage: Once Monthly). The following drugs were being taken at the same time:
  • Micardis (telmisartan)
  • Norvasc (amlodipine Besilate)
  • Tofranil (imipramine Hydrochloride)
When using Actonel, the patient experienced the following unwanted symptoms/side effects: Headache, Malaise, Nausea, DiarrhoeaThe 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 Headache, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9669224
Pancreatitis Acute, Necrosis, Biliary Cyst
This Pancreatitis Acute side effect was reported by a health professional from FR. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: osteoporosis,hypertension.The patient was prescribed Actonel (risedronate Sodium) Tablet, 35mg (drug dosage: Once Weekly), which was initiated on 2009. Concurrently used drugs:
  • Esidrex
.After starting to take Actonel (risedronate Sodium) Tablet, 35mg the consumer reported adverse symptoms, such as: Pancreatitis Acute, Necrosis, Biliary CystThese side effects may potentially be related to Actonel (risedronate Sodium) Tablet, 35mg. The patient was hospitalized.
Actonel Side Effect Report#9667207
Gastritis Atrophic, Abdominal Pain Upper, Diverticulitis
This is a report of a 62-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: mineral supplementation, who was treated with Actonel (dosage: 150mg Once Monthly, Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Gastritis Atrophic, Abdominal Pain Upper, Diverticulitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Gastritis Atrophic side effect. The patient was hospitalized.
Actonel Side Effect Report#9665804
Myalgia, Bone Pain
This report suggests a potential Actonel Myalgia side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoporosis and used Actonel (dosage: 1 Dose) starting NS. After starting Actonel the patient began experiencing various side effects, including: Myalgia, Bone PainAdditional drugs used concurrently: NA. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myalgia, may still occur.
Actonel Side Effect Report#9656524
Myocardial Infarction, Chondropathy, Thrombosis, Weight Decreased
This Myocardial Infarction problem was reported by a consumer or non-health professional from CA. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 04, 2010 this consumer started treatment with Actonel (risedronate Sodium) Tablet, Unkmg (dosage: NA). The following drugs were being taken at the same time:
  • Actemra (tocilizumab) 200 Mg Vial Genentech (600 Mg Every Four Weeks)
  • Rituxan (1000 Mg Day 1 And Day 15)
  • Diphenydramine Hcl (diphenydramine Hydrochloride)
  • Acetaminophen (paracetamol)
  • Methylprednisolone (methylprednisolone)
  • Prednisone (prednisone)
  • Calcium (calcium)
  • Vitamin D /00318501/ (colecalciferol)
When using Actonel (risedronate Sodium) Tablet, Unkmg, the patient experienced the following unwanted symptoms/side effects: Myocardial Infarction, Chondropathy, Thrombosis, Weight DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9652016
Plasmacytoma, Chest Pain, Swelling, Malaise
This Plasmacytoma side effect was reported by a consumer or non-health professional from CA. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Actonel (drug dosage: NA), which was initiated on 2008. Concurrently used drugs:
  • Fosamax
  • Risedronate Sodium
  • Glucosamine (glucosamine)
  • Vitamin D/00318501/colecalciferol
  • Inderal La (propanolol Hydrochloride)
  • Maxalt/01406501/(rizatriptan)
.After starting to take Actonel the consumer reported adverse symptoms, such as: Plasmacytoma, Chest Pain, Swelling, MalaiseThese side effects may potentially be related to Actonel.
Actonel Side Effect Report#9648514
Atypical Femur Fracture, Bone Disorder, Stress Fracture, Low Turnover Osteopathy, Pain In Extremity, Pathological Fracture, Osteoporosis, Fall, Dyspepsia
This is a report of a 65-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis,osteoporosis prophylaxis, who was treated with Actonel (dosage: 35 Mg Once Weekly, Oral, start time:
May 08, 2009), combined with: NA. and developed a serious reaction and side effect(s): Atypical Femur Fracture, Bone Disorder, Stress Fracture, Low Turnover Osteopathy, Pain In Extremity, Pathological Fracture, Osteoporosis, Fall, Dyspepsia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Atypical Femur Fracture side effect. The patient was hospitalized.
Actonel Side Effect Report#9648513
Atypical Femur Fracture, Myalgia, Arthralgia, Fall, Femur Fracture, Fracture Displacement, Comminuted Fracture, Stress Fracture, Bone Disorder
This report suggests a potential Actonel Atypical 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: osteoporosis,osteoporosis prophylaxis and used Actonel (dosage: 35 Mg Once Weekly, Oral) starting
Jan 16, 2009. After starting Actonel the patient began experiencing various side effects, including: Atypical Femur Fracture, Myalgia, Arthralgia, Fall, Femur Fracture, Fracture Displacement, Comminuted Fracture, Stress Fracture, Bone DisorderAdditional drugs used concurrently: NA.The patient was hospitalized. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atypical Femur Fracture, may still occur.
Actonel Side Effect Report#9648437
Femur Fracture, Fall, Fracture Displacement, Fracture Delayed Union, Pathological Fracture, Bone Disorder, Stress Fracture, Pain, Low Turnover Osteopathy
This Femur Fracture problem was reported by a consumer or non-health professional from US. A 88-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis,osteoporosis prophylaxis. On
Jan 11, 2006 this consumer started treatment with Actonel (dosage: 150 Mg Once Monthly, Oral). The following drugs were being taken at the same time: NA. When using Actonel, the patient experienced the following unwanted symptoms/side effects: Femur Fracture, Fall, Fracture Displacement, Fracture Delayed Union, Pathological Fracture, Bone Disorder, Stress Fracture, Pain, Low Turnover OsteopathyThe 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 Femur Fracture, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9648421
Atypical Femur Fracture, Fall, Stress Fracture, Bone Disorder, Low Turnover Osteopathy
This Atypical Femur Fracture side effect was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Actonel (drug dosage: NA), which was initiated on
Sep 09, 2008. Concurrently used drugs:
  • Boniva
  • Mobic (meloxicam)
  • Celebrex (celecoxib)
  • Advair (fluticasone Propionate, Salmeterol Xinafoate)
  • Mucinex
  • Alrex (loteprednol Etabonate)
  • Lexapro (escitalopram Oxalate)
  • Detrol La (tolterodine L-tartrate)
.After starting to take Actonel the consumer reported adverse symptoms, such as: Atypical Femur Fracture, Fall, Stress Fracture, Bone Disorder, Low Turnover OsteopathyThese side effects may potentially be related to Actonel. The patient was hospitalized.
Actonel Side Effect Report#9643035
Pathological Fracture, Femur Fracture, Fall
This is a report of a 60-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: osteopetrosis, who was treated with Actonel (risedronate Sodium)tablet, 150mg (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pathological Fracture, Femur Fracture, Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel (risedronate Sodium)tablet, 150mg treatment in female patients, resulting in Pathological Fracture side effect. The patient was hospitalized.
Actonel Side Effect Report#9642035
Myocardial Infarction, Cardiomegaly, Cardiac Disorder, Heart Rate Increased, Asthenia, Influenza Like Illness, Dysphonia, Pain, Chest Discomfort
This report suggests a potential Actonel Myocardial Infarction side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Actonel (dosage: NA) starting
Aug 02, 2013. After starting Actonel the patient began experiencing various side effects, including: Myocardial Infarction, Cardiomegaly, Cardiac Disorder, Heart Rate Increased, Asthenia, Influenza Like Illness, Dysphonia, Pain, Chest DiscomfortAdditional drugs used concurrently: NA. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Actonel Side Effect Report#9636493
Periprosthetic Fracture, Pain In Extremity, Rash, Malaise, Skeletal Injury, Low Turnover Osteopathy, Femur Fracture, Fracture Displacement, Pathological Fracture
This Periprosthetic Fracture problem was reported by a health professional from US. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
Mar 23, 2007 this consumer started treatment with Actonel (dosage: NA). The following drugs were being taken at the same time:
  • Fosamax
  • Prempro (estrogens Conjugated, Medroxyprogesterone Acetate)
  • Estradiol (estradiol) (gel)
  • Aleve (naproxen Sodium)
  • Phenergan /00033001/promethazine)
  • Glucosamine (glucosamine)
  • Chondroitin (chondroitin)
  • Fish Oil (fish Oil)
When using Actonel, the patient experienced the following unwanted symptoms/side effects: Periprosthetic Fracture, Pain In Extremity, Rash, Malaise, Skeletal Injury, Low Turnover Osteopathy, Femur Fracture, Fracture Displacement, Pathological FractureThe 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 Periprosthetic Fracture, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9633245
Femur Fracture, Pathological Fracture
This Femur Fracture side effect was reported by a consumer or non-health professional from US. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: bone disorder.The patient was prescribed Actonel (drug dosage: 1 Tablet), which was initiated on
Aug 11, 2013. Concurrently used drugs: NA..After starting to take Actonel the consumer reported adverse symptoms, such as: Femur Fracture, Pathological FractureThese side effects may potentially be related to Actonel. The patient was hospitalized.
Actonel Side Effect Report#9631088
Myocardial Infarction, Type 2 Diabetes Mellitus, Angina Pectoris, Vertigo
This is a report of a 70-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Actonel (risedronate Sodium) Tablet, 150 Mg (dosage: Once, start time:
Mar 01, 2010), combined with:
  • Spren
  • Plavix
  • Duride
  • Metoprolol
  • Somac
  • Progout
  • Metformin
  • Nitrolingual-spray
and developed a serious reaction and side effect(s): Myocardial Infarction, Type 2 Diabetes Mellitus, Angina Pectoris, Vertigo after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel (risedronate Sodium) Tablet, 150 Mg treatment in male patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.
Actonel Side Effect Report#9631086
Conjunctivitis, Eye Disorder, Melanocytic Naevus, Oral Pain, Oral Mucosal Exfoliation, Scab, Erythema
This report suggests a potential Actonel Conjunctivitis side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Actonel (dosage: One Dose Only) starting
Aug 04, 2013. After starting Actonel the patient began experiencing various side effects, including: Conjunctivitis, Eye Disorder, Melanocytic Naevus, Oral Pain, Oral Mucosal Exfoliation, Scab, ErythemaAdditional drugs used concurrently:
  • Alendronic Acid (alendronic Acid)
  • Adcal
  • Bendroflumethiazide
  • Glucosamine Sulphate
  • Paracetamol
  • Prednisolone
Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Conjunctivitis, may still occur.
Actonel Side Effect Report#9630932
Femur Fracture, Fracture Displacement, Pathological Fracture, Device Failure, Oedema Peripheral, Fracture Nonunion, Pain In Extremity
This Femur Fracture problem was reported by a consumer or non-health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 28, 2011 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: Femur Fracture, Fracture Displacement, Pathological Fracture, Device Failure, Oedema Peripheral, Fracture Nonunion, Pain In ExtremityThe 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 Femur Fracture, may become evident only after a product is in use by the general population.
Actonel Side Effect Report#9630746
Stress Fracture, Pain In Extremity, Muscular Weakness, Fracture Nonunion, Femur Fracture, Lumbar Spinal Stenosis, Fall, Dyspepsia, Osteoarthritis
This Stress Fracture side effect was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Actonel (drug dosage: NA), which was initiated on 200204. Concurrently used drugs:
  • Fosamax (alendronate Sodium)
  • Alendronate (alendronate Sodium)
  • Lorazepam (lorazepam)
  • Prevacid (lansoprazole)
  • Advair (fluticasone Propionate, Salmeterol Xinafoate)
  • Combivent (ipratropium Bromide, Salbutamol Sulfate)
  • Allegra
  • Singulair
.After starting to take Actonel the consumer reported adverse symptoms, such as: Stress Fracture, Pain In Extremity, Muscular Weakness, Fracture Nonunion, Femur Fracture, Lumbar Spinal Stenosis, Fall, Dyspepsia, OsteoarthritisThese side effects may potentially be related to Actonel.
Actonel Side Effect Report#9630715
Femur Fracture, Arthralgia, Fracture Displacement, Pathological Fracture, Fall, Pelvic Pain, Myositis, Exostosis
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Actonel (dosage: NA, start time: 200805), combined with: NA. and developed a serious reaction and side effect(s): Femur Fracture, Arthralgia, Fracture Displacement, Pathological Fracture, Fall, Pelvic Pain, Myositis, Exostosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actonel treatment in female patients, resulting in Femur Fracture side effect. The patient was hospitalized.


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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.

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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.

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    Discuss Actonel Side Effects

    Did You Have a Actonel Side Effect?

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    How Effective is Actonel for You?

    Exceeded Expectations
    Effective
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    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

    Latest Actonel clinical trials