PatientsVille.com Logo

PatientsVille

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.
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 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). The consumer presented with:
  • Atypical Femur Fracture
  • Injury
  • Bone Disorder
which developed 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.

Fall, Femur Fracture, Fracture Displacement, Pain In Extremity, Bone Disorder, Pathological Fracture, Stress Fracture
This report suggests a potential Actonel Fall, Femur Fracture, Fracture Displacement, Pain In Extremity, Bone Disorder, Pathological Fracture, Stress Fracture 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. Soon after starting Actonel the patient began experiencing various side effects, including:
  • Fall
  • Femur Fracture
  • Fracture Displacement
  • Pain In Extremity
  • Bone Disorder
  • Pathological Fracture
  • Stress Fracture
Drugs used concurrently: NA. Although Actonel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as fall, may still occur.

Femur Fracture, Stress Fracture, Pathological Fracture, Pain In Extremity
This Femur Fracture, Stress Fracture, Pathological Fracture, Pain In Extremity 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 commencing Actonel, the patient experienced the following unwanted symptoms/side effects:
  • Femur Fracture
  • Stress Fracture
  • Pathological Fracture
  • Pain In Extremity
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.

Femur Fracture, Pain In Extremity, Stress Fracture, Pathological Fracture, Fall, Bone Disorder
This is a report of a 53-year-old female patient (weight: NA) from KR. The patient developed the following symptoms/conditions: osteoporosis and was treated with Actonel (risedronate Sodium) Tablet, 35mg (dosage: 35 Mg Once Weekly, Oral) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Femur Fracture
  • Pain In Extremity
  • Stress Fracture
  • Pathological Fracture
  • Fall
  • Bone Disorder
This opens a possibility that Actonel (risedronate Sodium) Tablet, 35mg treatment could cause the above reactions, including femur fracture, and some female subjects may be more susceptible.


Osteomyelitis, Pain In Jaw, Secretion Discharge
A 75-year-old female patient (weight: NA) from JP with the following symptoms/conditions: osteoporosis started Actonel treatment (dosage: NA) on 2006. Soon after starting Actonel treatment, the subject experienced various side effects, including:
  • Osteomyelitis
  • Pain In Jaw
  • Secretion Discharge
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Actonel.

Osteomyelitis, Swelling Face, Trismus, Abscess Jaw, Exposed Bone In Jaw, Dental Fistula, Stomatitis
A 88-year-old female patient from JP (weight: NA) experienced symptoms, such as: osteoporosis and was treated with Actonel(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Osteomyelitis
  • Swelling Face
  • Trismus
  • Abscess Jaw
  • Exposed Bone In Jaw
  • Dental Fistula
  • Stomatitis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Actonel efficacy: NA.

Headache, Malaise, Nausea, Diarrhoea
In this report, Actonel was administered for the following condition: osteoporosis.A 66-year-old female consumer from JP (weight: NA) started Actonel treatment (dosage: Once Monthly) on Sep 01, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Headache
  • Malaise
  • Nausea
  • Diarrhoea
A possible interaction with other drugs could have contributed to this reaction:
  • Micardis (telmisartan)
  • Norvasc (amlodipine Besilate)
  • Tofranil (imipramine Hydrochloride)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Actonel treatment could be related to the listed above side effect(s).

Pancreatitis Acute, Necrosis, Biliary Cyst
This is a report of the following Actonel (risedronate Sodium) Tablet, 35mg side effect(s):
  • Pancreatitis Acute
  • Necrosis
  • Biliary Cyst
A 69-year-old male patient from FR (weight: NA) presented with the following condition: osteoporosis,hypertension and received a treatment with Actonel (risedronate Sodium) Tablet, 35mg (dosage: Once Weekly) starting: 2009.The following concurrently used drugs could have generated interactions:
  • Esidrex
The patient was hospitalized.This report suggests that a Actonel (risedronate Sodium) Tablet, 35mg treatment could be associated with the listed above side effect(s).

Gastritis Atrophic, Abdominal Pain Upper, Diverticulitis
This Actonel report was submitted by a 62-year-old female consumer from BR (weight: NA). The patient was diagnosed with: mineral supplementation and Actonel was administered (dosage: 150mg Once Monthly, Oral) starting: NS. The consumer developed a set of symptoms:
  • Gastritis Atrophic
  • Abdominal Pain Upper
  • Diverticulitis
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Actonel treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Myalgia, Bone Pain
This is a report of a possible correlation between Actonel use and the following symptoms/side effect(s):
  • Myalgia
  • Bone Pain
which could contribute to an assessment of Actonel risk profile.A female consumer from US (weight: NA) was suffering from osteoporosis and was treated with Actonel (dosage: 1 Dose) starting NS.Other concurrent medications: NA.

Myocardial Infarction, Chondropathy, Thrombosis, Weight Decreased
A 54-year-old female patient from CA (weight: NA) presented with the following symptoms: NA and after a treatment with Actonel (risedronate Sodium) Tablet, Unkmg (dosage: NA) experienced the following side effect(s):
  • Myocardial Infarction
  • Chondropathy
  • Thrombosis
  • Weight Decreased
The treatment was started on Nov 04, 2010. Actonel (risedronate Sodium) Tablet, Unkmg was used in combination with the following drugs:
  • 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)
This report could alert potential Actonel (risedronate Sodium) Tablet, Unkmg consumers.

Plasmacytoma, Chest Pain, Swelling, Malaise
In this report, a 63-year-old female patient from CA (weight: NA) was affected by a possible Actonel side effect.The patient was diagnosed with NA. After a treatment with Actonel (dosage: NA, start date: 2008), the patient experienced the following side effect(s):
  • Plasmacytoma
  • Chest Pain
  • Swelling
  • Malaise
The following simultaneously used drugs could have led to this reaction:
  • Fosamax
  • Risedronate Sodium
  • Glucosamine (glucosamine)
  • Vitamin D/00318501/colecalciferol
  • Inderal La (propanolol Hydrochloride)
  • Maxalt/01406501/(rizatriptan)
The findings here stress that side effects should be taken into consideration when evaluating a Actonel treatment.

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 from US (weight: NA), who used Actonel (dosage: 35 Mg Once Weekly, Oral) for a treatment of osteoporosis,osteoporosis prophylaxis. After starting a treatment on May 08, 2009, the patient experienced the following side effect(s):
  • Atypical Femur Fracture
  • Bone Disorder
  • Stress Fracture
  • Low Turnover Osteopathy
  • Pain In Extremity
  • Pathological Fracture
  • Osteoporosis
  • Fall
  • Dyspepsia
The following drugs could possibly have interacted with the Actonel treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Actonel treatment could be related to side effect(s), such as Atypical Femur Fracture, Bone Disorder, Stress Fracture, Low Turnover Osteopathy, Pain In Extremity, Pathological Fracture, Osteoporosis, Fall, Dyspepsia.

Atypical Femur Fracture, Myalgia, Arthralgia, Fall, Fracture Displacement, Comminuted Fracture, Stress Fracture, Bone Disorder
This atypical femur fracture side effect was reported by a health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis,osteoporosis prophylaxis. The patient was prescribed Actonel (dosage: 35 Mg Once Weekly, Oral), which was started on Jan 16, 2009. Concurrently used drugs: NA. When starting to take Actonel the consumer reported the following symptoms:
  • Atypical Femur Fracture
  • Myalgia
  • Arthralgia
  • Fall
  • Fracture Displacement
  • Comminuted Fracture
  • Stress Fracture
  • Bone Disorder
The patient was hospitalized. These side effects may potentially be related to Actonel.

Femur Fracture, Fall, Fracture Displacement, Fracture Delayed Union, Pathological Fracture, Bone Disorder, Stress Fracture, Pain, Low Turnover Osteopathy
This is a Actonel side effect report of a 88-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: osteoporosis,osteoporosis prophylaxis, who was treated with Actonel (dosage:150 Mg Once Monthly, Oral, start time: Jan 11, 2006), combined with: NA., and developed a serious reaction and a femur fracture side effect. The patient presented with:
  • Femur Fracture
  • Fall
  • Fracture Displacement
  • Fracture Delayed Union
  • Pathological Fracture
  • Bone Disorder
  • Stress Fracture
  • Pain
  • Low Turnover Osteopathy
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Actonel treatment in female patients suffering from osteoporosis,osteoporosis prophylaxis, resulting in femur fracture.

Atypical Femur Fracture, Fall, Stress Fracture, Bone Disorder, Low Turnover Osteopathy
This report suggests a potential Actonel atypical femur fracture side effect(s) that can have serious consequences. A 58-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): osteoporosis and used Actonel (dosage: NA) starting Sep 09, 2008. Soon after starting Actonel the patient began experiencing various side effects, including:
  • Atypical Femur Fracture
  • Fall
  • Stress Fracture
  • Bone Disorder
  • Low Turnover Osteopathy
Drugs used concurrently:
  • Boniva
  • Mobic (meloxicam)
  • Celebrex (celecoxib)
  • Advair (fluticasone Propionate, Salmeterol Xinafoate)
  • Mucinex
  • Alrex (loteprednol Etabonate)
  • Lexapro (escitalopram Oxalate)
  • Detrol La (tolterodine L-tartrate)
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.

Pathological Fracture, Femur Fracture, Fall
This pathological fracture problem was reported by a consumer or non-health professional from CA. A 60-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): osteopetrosis.On NS a consumer started treatment with Actonel (risedronate Sodium)tablet, 150mg (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Actonel (risedronate Sodium)tablet, 150mg, the patient experienced the following unwanted symptoms /side effects:
  • Pathological Fracture
  • Femur Fracture
  • Fall
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as pathological fracture, may become evident only after a product is in use by the general population.

Myocardial Infarction, Cardiomegaly, Cardiac Disorder, Heart Rate Increased, Asthenia, Influenza Like Illness, Dysphonia, Pain, Chest Discomfort
This is a Actonel side effect report of a 77-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Actonel (dosage: NA) starting Aug 02, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Myocardial Infarction
  • Cardiomegaly
  • Cardiac Disorder
  • Heart Rate Increased
  • Asthenia
  • Influenza Like Illness
  • Dysphonia
  • Pain
  • Chest Discomfort
This opens a possibility that Actonel could cause myocardial infarction and that some female patients may be more susceptible.

Periprosthetic Fracture, Pain In Extremity, Rash, Malaise, Skeletal Injury, Low Turnover Osteopathy, Femur Fracture, Fracture Displacement, Pathological Fracture
A 48-year-old female patient (weight: NA) from US with the following symptoms: osteoporosis started Actonel treatment (dosage: NA) on Mar 23, 2007. Soon after starting Actonel treatment, the consumer experienced several side effects, including:
  • Periprosthetic Fracture
  • Pain In Extremity
  • Rash
  • Malaise
  • Skeletal Injury
  • Low Turnover Osteopathy
  • Femur Fracture
  • Fracture Displacement
  • Pathological Fracture
. Concurrently used drugs:
  • Fosamax
  • Prempro (estrogens Conjugated, Medroxyprogesterone Acetate)
  • Estradiol (estradiol) (gel)
  • Aleve (naproxen Sodium)
  • Phenergan /00033001/promethazine)
  • Glucosamine (glucosamine)
  • Chondroitin (chondroitin)
  • Fish Oil (fish Oil)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Actonel side effects, such as periprosthetic fracture.

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 (dosage: 1 Tablet), which was started on Aug 11, 2013. Concurrently used drugs: NA..When starting to take Actonel the consumer reported symptoms, such as:
  • Femur Fracture
  • Pathological Fracture
These side effects may potentially be related to Actonel. The patient was hospitalized.

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 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). The consumer presented with:
  • Myocardial Infarction
  • Type 2 Diabetes Mellitus
  • Angina Pectoris
  • Vertigo
which developed 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.

Conjunctivitis, Eye Disorder, Melanocytic Naevus, Oral Pain, Oral Mucosal Exfoliation, Scab, Erythema
This report suggests a potential Actonel Conjunctivitis, Eye Disorder, Melanocytic Naevus, Oral Pain, Oral Mucosal Exfoliation, Scab, Erythema 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. Soon after starting Actonel the patient began experiencing various side effects, including:
  • Conjunctivitis
  • Eye Disorder
  • Melanocytic Naevus
  • Oral Pain
  • Oral Mucosal Exfoliation
  • Scab
  • Erythema
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.

Femur Fracture, Fracture Displacement, Pathological Fracture, Device Failure, Oedema Peripheral, Fracture Nonunion, Pain In Extremity
This Femur Fracture, Fracture Displacement, Pathological Fracture, Device Failure, Oedema Peripheral, Fracture Nonunion, Pain In Extremity 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 commencing Actonel, the patient experienced the following unwanted symptoms/side effects:
  • Femur Fracture
  • Fracture Displacement
  • Pathological Fracture
  • Device Failure
  • Oedema Peripheral
  • Fracture Nonunion
  • Pain In Extremity
The 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.

Stress Fracture, Pain In Extremity, Muscular Weakness, Fracture Nonunion, Femur Fracture, Lumbar Spinal Stenosis, Fall, Dyspepsia, Osteoarthritis
This is a report of a 60-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: osteoporosis and was treated with Actonel (dosage: NA) starting 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
Soon after that, the consumer experienced the following side effects:
  • Stress Fracture
  • Pain In Extremity
  • Muscular Weakness
  • Fracture Nonunion
  • Femur Fracture
  • Lumbar Spinal Stenosis
  • Fall
  • Dyspepsia
  • Osteoarthritis
This opens a possibility that Actonel treatment could cause the above reactions, including stress fracture, and some female subjects may be more susceptible.

Femur Fracture, Arthralgia, Fracture Displacement, Pathological Fracture, Fall, Pelvic Pain, Myositis, Exostosis
A 63-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Actonel treatment (dosage: NA) on 200805. Soon after starting Actonel treatment, the subject experienced various side effects, including:
  • Femur Fracture
  • Arthralgia
  • Fracture Displacement
  • Pathological Fracture
  • Fall
  • Pelvic Pain
  • Myositis
  • Exostosis
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Actonel.

  2 of 109 



Top 10 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

Top 10 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

Keep Track of Side Effects

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

    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.


    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

    Latest Actonel clinical trials