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Actonel Side Effects

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.

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.

Actonel Side Effects Reported to FDA

The following 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.


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.
Femur Fracture, Fracture Displacement, Pathological Fracture, Bone Pain, Nausea, Vomiting, Dyspepsia
on Oct 15, 2013 Female from US , 70 years of age, was diagnosed with and was treated with Actonel. Directly after, patient experienced the unwanted or unexpected Actonel side effects: femur fracture, fracture displacement, pathological fracture, bone pain, nausea, vomiting, dyspepsia. Actonel dosage: N/A.
Associated medications used:
  • Fosamax Plus D (Once Weekly)
  • Fosamax
  • Tamoxifen
  • Miacalcin (calcitonin, Salmon)
  • Forteo (teriparatide)
  • Mevacor (lovastatin)
  • Vasotec /00574902/ (enalapril Maleate)
  • Motrin (ibuprofen)
Patient was hospitalized.

Atypical Femur Fracture, Bone Disorder, Fall, Osteoporosis
Patient was taking Actonel. Patient felt the following Actonel side effects: atypical femur fracture, bone disorder, fall, osteoporosis on Dec 04, 2013 from JP Additional patient health information: Female , 83 years of age, was diagnosed with and. Actonel dosage: Once Weekly. Patient was hospitalized.

Femur Fracture, Bone Disorder, Atypical Femur Fracture, Fall
Adverse event was reported on Dec 04, 2013 by a Female taking Actonel (Dosage: 17.5 Mg Once Weekly, Oral) was diagnosed with and. Location: JP , 74 years of age, After Actonel was administered, patient encountered several Actonel side effects: femur fracture, bone disorder, atypical femur fracture, fall. Patient was hospitalized.

Fall, Atypical Femur Fracture, Fracture Displacement, Comminuted Fracture, Pain In Extremity
on Oct 10, 2013 Female from US , 56 years of age, weighting 161.8 lb, was treated with Actonel. Directly after, patient experienced the unwanted or unexpected Actonel side effects: fall, atypical femur fracture, fracture displacement, comminuted fracture, pain in extremity. Actonel dosage: N/A.
Associated medications used:
  • Prednisone (prednisone)
  • Leflunomide (leflunomide)
  • Rituxan (rituximab)
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Potassium Chloride (potassium Chloride)
  • Aspirin (acetylsalicylic Acid)
  • Soma (carisoprodol)
  • Gabapentin (gabapentin)
Patient was hospitalized.


Femur Fracture, Comminuted Fracture, Fracture Displacement, Pain In Extremity, Fall
on Oct 10, 2013 Female from US , 59 years of age, weighting 145.5 lb, was treated with Actonel (risedronate Sodium) Tablet, 150 Mg. Patient felt the following Actonel side effects: femur fracture, comminuted fracture, fracture displacement, pain in extremity, fall. Actonel (risedronate Sodium) Tablet, 150 Mg dosage: N/A.
Multiple prescriptions taken:
  • Actonel (risedronate Sodium) Tablet, 35 Mg
  • Prednisone (prednisone)
  • Hydroxychloroquine (hydroxychloroquine)
  • Nadolol (nadolol)
  • Gabapentin (gabapentin)
  • Trazodone (trazodone)
  • Alprazolam (alprazolam)
  • Lunesta (eszopiclone)
Patient was hospitalized.

Eructation
Patient was taking Actonel. After Actonel was administered, patient encountered several Actonel side effects: eructation on Oct 11, 2013 from US Additional patient health information: Female , 58 years of age, weighting 170.0 lb, was diagnosed with and. Actonel dosage: N/A.

Fracture Displacement, Periprosthetic Fracture, Pathological Fracture, Fracture Nonunion
Adverse event was reported on Oct 09, 2013 by a Female taking Actonel (risedronate Sodium) Tablet, 35mg (Dosage: 35 Mg Once Weekly, Oral) was diagnosed with and. Location: US , 69 years of age, weighting 200.4 lb, Directly after, patient experienced the unwanted or unexpected Actonel side effects: fracture displacement, periprosthetic fracture, pathological fracture, fracture nonunion.
Associated medications used:
  • Levothyroxin (levothyroxine Sodium)
  • Metformin Er (metformin Hydrochloride)
  • Aspirin (acetylsalicylic Acid)
  • Hydrochlorothiazide (hyrochlorothiazide)
  • Diltiazem
  • Valsartan (valsartan)
  • Byetta (exenatide)
  • Celebrex (celecoxib)
Patient was hospitalized.

Pathological Fracture, Fracture Displacement, Femur Fracture, Pain In Extremity, Osteonecrosis Of Jaw, Gingival Pain, Device Issue, Gingival Ulceration, Primary Sequestrum
on Oct 09, 2013 Female from US , 73 years of age, was treated with Actonel. Patient felt the following Actonel side effects: pathological fracture, fracture displacement, femur fracture, pain in extremity, osteonecrosis of jaw, gingival pain, device issue, gingival ulceration, primary sequestrum. Actonel dosage: N/A.
Multiple prescriptions taken:
  • Alendronate (70 Mg Once Weekly, Oral)
  • Prednisone (prednisone)
  • Aspirin (acetylsalicylic Acid)
  • Fosamax D (70 Mg Once Weekly, Oral)
  • Atenolol (atenolol)
  • Amlodipine (amlodipine)
  • Ramipril (ramipril)
  • Lipitor (atorvastatin Calcium)
Patient was hospitalized.

Back Pain, Constipation, Abdominal Distension, Spinal Pain, Musculoskeletal Pain, Faeces Discoloured
on Oct 08, 2013 Female from US , 50 years of age, weighting 129.0 lb, was diagnosed with and was treated with Actonel. After Actonel was administered, patient encountered several Actonel side effects: back pain, constipation, abdominal distension, spinal pain, musculoskeletal pain, faeces discoloured. Actonel dosage: 1 Monthly.

Femur Fracture, Fall, Pain In Extremity, Osteopenia, Deep Vein Thrombosis, Post Procedural Complication, Liver Function Test Abnormal
Patient was taking Actonel (risedronate Sodium) Tablet, 35mg. Directly after, patient experienced the unwanted or unexpected Actonel side effects: femur fracture, fall, pain in extremity, osteopenia, deep vein thrombosis, post procedural complication, liver function test abnormal on Oct 07, 2013 from US Additional patient health information: Female , 62 years of age, weighting 154.3 lb, was diagnosed with and. Actonel (risedronate Sodium) Tablet, 35mg dosage: 35 Mg Once Weekly, Oral.
Associated medications used:
  • Boniva (ibandronate Sodium) (150 Mg Once Monthly, Oral)
  • Tylenol (paracetamol)
  • Propoxyphene Hydrochloride W/paracetamol (dextropropoxyphene Hydrochloride, Paracetamol)
  • Tizanidine (tizanidine)
  • Allegra
  • Buspirone (buspirone)
  • Ambien (zolpidem Tartrate)
  • Chlorhexidine Gluconate (chlorhexidine Gluconate)
Patient was hospitalized.

Stress Fracture, Fall, Pain In Extremity, Bone Disorder, Femur Fracture, Osteochondroma, Osteoarthritis
Adverse event was reported on Oct 07, 2013 by a Female taking Actonel (Dosage: N/A) . Location: US , 70 years of age, weighting 119.9 lb, Patient felt the following Actonel side effects: stress fracture, fall, pain in extremity, bone disorder, femur fracture, osteochondroma, osteoarthritis.
Multiple prescriptions taken:
  • Fosamax
  • Alendronate (alendronate Sodium)
  • Singulair
  • Spiriva(tiotropium Bromide)
  • Brovana(arformoterol Tartrate)


Atypical Femur Fracture, Comminuted Fracture, Fracture Displacement, Muscle Spasms, Fall
on Oct 07, 2013 Female from US , 72 years of age, was treated with Actonel (risedronate Sodium) Tablet, 150mg. After Actonel was administered, patient encountered several Actonel side effects: atypical femur fracture, comminuted fracture, fracture displacement, muscle spasms, fall. Actonel (risedronate Sodium) Tablet, 150mg dosage: 150 Mg Once Monthly, Oral.
Multiple concurrent drugs taken:
  • Actonel (risedronate Sodium) Tablet, 35mg (35 Mg Once Weekly, Oral)
Patient was hospitalized.

Femur Fracture, Fall, Pain In Extremity, Stress Fracture, Fracture Displacement, Osteoarthritis, Exostosis
on Jan 30, 2014 Female from US , 78 years of age, weighting 175.0 lb, was treated with Actonel. Directly after, patient experienced the unwanted or unexpected Actonel side effects: femur fracture, fall, pain in extremity, stress fracture, fracture displacement, osteoarthritis, exostosis. Actonel dosage: N/A.
Associated medications used:
  • Fosamax
  • Amlodipine (amlodipine)
  • Fluoxetine (fluoxetine)
  • Leflunomide (leflunomide)
  • Calcium (calcium)
  • Vitamin D /00318501/colcalciferol)
  • Prednisone
  • Alendronate
Patient was hospitalized.

Pathological Fracture, Femur Fracture, Fracture Nonunion, Device Breakage, Complication Of Device Removal, Osteopetrosis, Pain In Extremity, Low Turnover Osteopathy, Atypical Femur Fracture
Patient was taking Actonel. Patient felt the following Actonel side effects: pathological fracture, femur fracture, fracture nonunion, device breakage, complication of device removal, osteopetrosis, pain in extremity, low turnover osteopathy, atypical femur fracture on Jan 15, 2014 from US Additional patient health information: Female , 52 years of age, weighting 201.9 lb, was diagnosed with and. Actonel dosage: 35 Mg Once Weekly, Oral.
Multiple prescriptions taken:
  • Risedronate Sodium
  • Fosamax (35 Mg Once Weekly, Oral)
  • Fosamax D
  • Alendronate Sodium (alendronate Sodium) (alendronate Sodium)
  • Boniva (150 Mg Once Monthly, Oral)
  • Ibandronate Sodium
  • Deltasone (prednisone)
  • Plaquenil (hydroxychloroquine Phosphate)
Patient was hospitalized.

Atypical Femur Fracture, Fall, Arthralgia
Adverse event was reported on Sep 19, 2013 by a Female taking Actonel (risedronate Sodium) Tablet (Dosage: N/A) . Location: US , 72 years of age, weighting 114.0 lb, After Actonel was administered, patient encountered several Actonel side effects: atypical femur fracture, fall, arthralgia.
Multiple concurrent drugs taken:
  • Fosamax (alendronate Sodium)
  • Prempro (estrogens Conjugated, Medroxyprogesterone Acetate)
  • Premarin (estrogens Conjugated)
  • Vioxx (rofecoxib)
  • Multivitamin /00831701/)
  • Vitamin D / 00318501/(colecalciferol)
  • Calcium (calcium)
Patient was hospitalized.

Femur Fracture, Comminuted Fracture, Fracture Displacement, Stress Fracture, Fall
on Sep 19, 2013 Female from US , 77 years of age, was diagnosed with and was treated with Actonel. Directly after, patient experienced the unwanted or unexpected Actonel side effects: femur fracture, comminuted fracture, fracture displacement, stress fracture, fall. Actonel dosage: 35mg Once Weekly, Oral.
Associated medications used:
  • Alendronate (70mg Once Weekly, Oral)
  • Premarin
  • Lisinopril Hydrochlorthiazid (hydrochlorothiazide, Lisinopril)
  • Metoprolol (metoprolol)
  • Vitamin E (tocopherol)
  • Simvastatin (simvastatin)
  • Lipitor (atorvastatin Calcium)
  • Astelin (azelastine Hydrochloride)
Patient was hospitalized.

Femur Fracture, Fall, Pain In Extremity, Fracture Displacement, Comminuted Fracture, Osteonecrosis, Spinal Osteoarthritis, Arthropathy, Scoliosis
on Sep 19, 2013 Female from US , 77 years of age, was treated with Actonel. Patient felt the following Actonel side effects: femur fracture, fall, pain in extremity, fracture displacement, comminuted fracture, osteonecrosis, spinal osteoarthritis, arthropathy, scoliosis. Actonel dosage: N/A.
Multiple prescriptions taken:
  • Fosamax
  • Levothyroxine(levothyroxine)
  • Atenolol(atenolol)
  • Tenoretic (atenolol, Chlortalidone)
  • Prinivil (lisinopril Dihyrdate)
  • Prinzide(hydrochlorothiazide, Lisinopril Dihydrate)
  • Aspirin(acetylsalicylic Acid)
  • Simvastatin (simvastatin)
Patient was hospitalized.

Gastrointestinal Disorder
Patient was taking Actonel. After Actonel was administered, patient encountered several Actonel side effects: gastrointestinal disorder on Sep 17, 2013 from AU Additional patient health information: Female , 92 years of age, . Actonel dosage: N/A.

Femur Fracture, Stress Fracture, Fracture Nonunion, Fracture Displacement, Joint Crepitation, Device Breakage, Bone Density Decreased, Condition Aggravated, Arthralgia
Adverse event was reported on Sep 17, 2013 by a Female taking Actonel (Dosage: 35 Mg Once Weekly, Oral) was diagnosed with and. Location: US , 55 years of age, weighting 164.2 lb, Directly after, patient experienced the unwanted or unexpected Actonel side effects: femur fracture, stress fracture, fracture nonunion, fracture displacement, joint crepitation, device breakage, bone density decreased, condition aggravated, arthralgia.
Associated medications used:
  • Fosamax
  • Activella (estradiol, Norethisterone Acetate)
  • Aciphex (rabeprazole Sodium)
  • Detrol (tolterodine L-tartrate)
  • Calcium (calcium)
Patient was hospitalized.

Femur Fracture, Fall, Periprosthetic Fracture, Femoral Neck Fracture
on Sep 17, 2013 Female from US , 68 years of age, was treated with Actonel. Patient felt the following Actonel side effects: femur fracture, fall, periprosthetic fracture, femoral neck fracture. Actonel dosage: N/A. Patient was hospitalized.

Femur Fracture, Pathological Fracture, Muscular Weakness, Pain In Extremity, Fall, Fracture Displacement, Stress Fracture, Bone Disorder, Low Turnover Osteopathy
on Sep 24, 2013 Female from US , 61 years of age, weighting 119.9 lb, was diagnosed with and was treated with Actonel (risedronate Sodium) Tablet, 35mg. After Actonel was administered, patient encountered several Actonel side effects: femur fracture, pathological fracture, muscular weakness, pain in extremity, fall, fracture displacement, stress fracture, bone disorder, low turnover osteopathy. Actonel (risedronate Sodium) Tablet, 35mg dosage: 35 Mg Once Weekly, Po.
Multiple concurrent drugs taken:
  • Fosamax (alendronate Sodium) (70 Mg Once Weekly, Oral)
  • Alendronate Sodium (alendronate Sodium) (alendronate Sodium) (70 Mg Once Weekly, Oral)
  • Methotrexate (methotrexate)
  • Folic Acid (folic Acid)
  • Nabumetone (relafen)
  • Digoxin (digoxin)
  • Altace (ramipril)
  • Warfarin (warfarin)
Patient was hospitalized.

Fall, Femur Fracture, Osteoporotic Fracture, Fracture Displacement
Patient was taking Actonel (risedronate Sodium) Tablet, 5mg. Directly after, patient experienced the unwanted or unexpected Actonel side effects: fall, femur fracture, osteoporotic fracture, fracture displacement on Sep 17, 2013 from US Additional patient health information: Female , 79 years of age, weighting 131.4 lb, was diagnosed with and. Actonel (risedronate Sodium) Tablet, 5mg dosage: 5 Mg Once Daily, Oral.
Associated medications used:
  • Fosamax (alendronate Sodium) (10 Mg Once Daily, Oral)
  • Boniva (bandronate Sodium) (150 Mg Once Montly, Oral)
  • Evista (raloxifene Hydrochloride)
  • Aciphex (rabeprazole Sodium)
  • Pepcid / 00706001 (famotidine)
Patient was hospitalized.

Tremor, Mastitis
Adverse event was reported on Sep 13, 2013 by a Female taking Actonel (Dosage: N/A) was diagnosed with and. Location: US , 62 years of age, weighting 185.0 lb, Patient felt the following Actonel side effects: tremor, mastitis.
Multiple prescriptions taken:
  • Lipitor
  • Multivitamin
  • Glucosamine
  • Chondroitin
  • Vitamin C
  • Caltrata Calcium
  • Vitamin D


Pain, Dizziness, Asthenia, Nausea, Haematochezia, Haematemesis, Gastrointestinal Haemorrhage
on Sep 09, 2013 Male from US , 67 years of age, weighting 180.0 lb, was diagnosed with and was treated with Actonel. After Actonel was administered, patient encountered several Actonel side effects: pain, dizziness, asthenia, nausea, haematochezia, haematemesis, gastrointestinal haemorrhage. Actonel dosage: Took Only 1 Pill. Patient was hospitalized and became disabled.

Atypical Femur Fracture, Fall, Fracture Displacement, Muscular Weakness, Stress Fracture, Skeletal Injury, Low Turnover Osteopathy, Pain
on Oct 21, 2013 Female from US , 59 years of age, weighting 153.9 lb, was diagnosed with and was treated with Actonel. Directly after, patient experienced the unwanted or unexpected Actonel side effects: atypical femur fracture, fall, fracture displacement, muscular weakness, stress fracture, skeletal injury, low turnover osteopathy, pain. Actonel dosage: N/A. Patient was hospitalized.

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Note Your Observations

It is really important to keep of your 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


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    Discuss Actonel Side Effects

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    How Effective is Actonel for You?

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