Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aclasta (Zoledronic-acid). If you are concerned about side effects, discuss the risks and benefits of Aclasta (Zoledronic-acid) with your doctor.

The following side effects have been reported by at least 1% of people taking Aclasta (Zoledronic-acid). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• Constipation
• decreased appetite
• Diarrhea
• dizziness
• excessive sweating
• Fever and chills
• flu-like symptoms (e.g., fever, chills, bone pain, or muscle and joint pain)
• general feeling of being unwell
• headache
• nasal congestion
• nausea
• rash
• skin reaction at the injection site (e.g., redness, swelling or pain)
• sore throat
• tiredness
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• broken bones not healing
• eye pain, redness, or inflammation
• fast or irregular heartbeat
• joint and bone pain, joint stiffness, muscle spasms
• persistent ear pain
• sensitivity of the eyes to light
• signs of osteonecrosis of the jaw (e.g., swelling or gum infections, bad breath, poor healing of the gums, feeling of numbness or heaviness in the jaw)
• shortness of breath, wheezing, or coughing (if allergic to Asa)
• signs of kidney failure (e.g., weakness, tiredness, loss of appetite, puffy eyes, hand and feet, decreased urine production or changed urine colour)
• signs of low blood calcium levels (e.g., muscle spasms, tingling or numbness of the fingers and mouth, twitching, or memory loss)
• skin rash
• thigh or groin pain
• weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Anaphylaxis (severe allergic reaction) (e.g., Hives; difficulty breathing; swelling of the mouth, lips, tongue, or throat)
• signs of Stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in the arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aclasta (Zoledronic-acid).

Each bottle of ready-to-use sterile solution for intravenous infusion contains zoledronic acid 5 mg/100 mL monohydrate 5.330 mg (equivalent to 5 mg zoledronic acid on an anhydrous basis). Nonmedicinal ingredients: mannitol, sodium citrate, and water for injection. The colourless plastic bottle is sealed with a rubber stopper which is held in place with an aluminum cap with flip component. The stopper is made of bromobutyl rubber coated with fluorocarbon polymer and contains no latex.

Do not use zoledronic acid if you:

• are allergic to zoledronic acid or any ingredient of Aclasta (Zoledronic-acid)
• are allergic to any other bisphosphonate medication (e.g., Alendronate, etidronate)
• are pregnant or breast-feeding
• have severely decreased kidney function
• have low blood calcium levels that have not been corrected

There may be an interaction between zoledronic acid and any of the following:

• aminoglycosides (e.g., gentamicin, tobramycin)
• Calcitonin
• diuretics (water pills; e.g., Hydrochlorothiazide, Furosemide)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• phosphate supplements
• medications that prevent blood vessel growth in tumours (e.g., Axitinib, Bevacizumab, Lenalidomide, Pazopanib, Regorafenib, Sorafenib, Sunitinib, thalidomide)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

ASA allergy: Although not reported with zoledronic acid, people who are allergic to acetylsalicylic acid (ASA) have had breathing problems after using other medications in the same family as zoledronic acid. Let your doctor know if you are allergic to ASA.

Atrial fibrillation: Aclasta (Zoledronic-acid) has been shown to increase the risk of atrial fibrillation (irregular heartbeat) in some clinical trials. Contact your doctor if you feel palpitations, a rapid and irregular heartbeat, dizziness, weakness, or shortness of breath.

Atypical femur fracture: There is evidence that long-term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of injury. If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.

Deterioration of the jaw bone: People with cancer who are being treated with zoledronic acid (or other bisphosphonates) have a higher risk of developing osteonecrosis of the jaw (deterioration of the jaw bone). If you take zoledronic acid, report any pain, swelling, or infection of the jaw to your doctor, and avoid invasive dental procedures such as tooth extractions.

Eye inflammation: People using zoledronic acid have reported experiencing symptoms of eye inflammation. If you experience changes to your vision, red eyes, or eye pain, contact your doctor as soon as possible.

Hydration: If you are using Aclasta (Zoledronic-acid), you must be well-hydrated, especially if you are taking diuretics (water pills). On the day that zoledronic acid is given, you should eat normally and drink at least 2 glasses (500 mL or 2 cups) of water before and after receiving the medication.

Kidney function: As with other bisphosphonates, the use of zoledronic acid has been associated with kidney problems. If you have Kidney Disease, or have a history of kidney disease, let your doctor know about these conditions before starting Aclasta (Zoledronic-acid), as it may aggravate kidney problems. The use of zoledronic acid is not recommended for people with severe kidney impairment.

Low blood calcium levels: Before starting zoledronic acid, people who have low blood calcium levels must adjust their levels with calcium and vitamin D supplements as recommended by their doctors. If you take zoledronic acid, you should take calcium and vitamin D supplements to prevent low blood calcium levels. Your doctor will recommend an appropriate dose for these supplements based on your needs.

Pregnancy: Zoledronic acid should not be used during pregnancy as it may harm the developing baby. If you become pregnant while receiving Aclasta (Zoledronic-acid), contact your doctor immediately.

Breast-feeding: It is not known if zoledronic acid passes into breast milk. If you are a breast-feeding mother and are taking Aclasta (Zoledronic-acid), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aclasta (Zoledronic-acid) have not been established for children less than 18 years of age.