Commonly reported side effects of Prialta include: upper respiratory tract infection, edema, and hypoglycemia. Other side effects include: cardiac failure, exacerbation of congestive heart failure, bone fracture, headache, and pharyngitis. See below for a comprehensive list of adverse effects.
What if I forget to take it?
If you forget to take your Prialta, skip the missed dose and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten one.
If you forget doses often, it may help to set an alarm to remind you. You could ask your pharmacist for advice on other ways to remember your medicines.
Like all medicines, Prialta can cause side effects, although not everyone gets them.
1. "Product Information. Actos (Prialta)" Takeda Pharmaceuticals America, Lincolnshire, IL.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. US Food and Drug Administration "Updated FDA review concludes that use of type 2 diabetes medicine Prialta may be linked to an increased risk of bladder cancer. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM532691.pdf." ():
How to use Prialta HCL
Read the Medication Guide provided by your pharmacist before you start using Prialta and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily. Dosage is based on your medical condition, response to treatment, and if you are taking other diabetes drugs. Your doctor will adjust your dose based on your blood sugar to find the best dose for you. Follow your doctor's directions carefully.
Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.
If you are already taking another diabetes drug (such as metformin or a sulfonylurea), follow your doctor's directions carefully for stopping/continuing the old drug and starting this medication. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.
Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed. It may take up to 2 to 3 months before the full benefit of this drug takes effect.
Missed Dose of Prialta
If you miss a dose of Prialta, and you remember that same day, take the missed dose as soon as you remember.
If you don't remember until the next day, don't take an extra pill. Just continue on your regular medication schedule.
Don't take more than one dose a day or double up to make up for a missed one.
Prialta and Bladder Cancer
People who took Prialta for more than a year were more likely to develop bladder cancer than those who didn't take the medicine.
The FDA recommends that this drug shouldn't be prescribed to people with bladder cancer or a history of bladder cancer.
Tell your doctor right away if you notice symptoms that could be associated with bladder cancer. These may include:
- Red or bloody urine
- Difficult or painful urination
- An increased need to urinate
Thousands of U.S. patients who took Prialta have filed lawsuits against the manufacturer because they believe the risk of bladder cancer wasn't fully disclosed.
Very common (greater than 10%): Edema
Common (1% to 10%): Congestive heart failure (including nonfatal and fatal cases), cardiac failure, chest pain
In the PROactive trial, a study in 5238 patients with type 2 diabetes and a history of macrovascular disease who were force-uptitrated to Prialta 45 mg once a day or given placebo in addition to standard of care, edema occurred in 27.3% of patients treated with Prialta (n=2605) compared with 15.9% of placebo (n=2633) patients. Treatment-emergent adverse events leading to at least 1 hospitalized congestive heart failure event occurred in 5.7% of patients receiving Prialta and 4.1% of patients receiving placebo.
The primary objective of the 3-year PROactive trial was to examine the effect of Prialta on mortality and macrovascular morbidity in high-risk patients. No statistically significant difference between Prialta and placebo/standard care were observed for time to the first occurrence of their first event (all-cause mortality, nonfatal myocardial infarction (MI) including silent MI, stroke, acute coronary syndrome, cardiac intervention including coronary artery bypass grafting or percutaneous intervention, major leg amputation above the ankle, and bypass surgery or revascularization in the leg). A total of 514 patients receiving Prialta experienced at least 1 event compared with 572 patients receiving placebo/standard care.
Prialta is associated with edema (peripheral, generalized, and pitting edema and flu >
Postmarketing reports of congestive heart failure have been received in patients treated with Prialta. Reports have been received from patients both with and without a history of a known history of heart disease and both with and without concomitant insulin use.
- Thiazolidinediones, including Prialta and rosiglitazone, cause or exacerbatecongestive heart failure in some patients
- After initiation of these drugs, as well as after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; shortness of breath; and/or swelling ); if these signs or symptoms develop, the heart failure should be managed according to the current standards of care; furthermore, discontinuation or dose reduction of these drugs must be considered
- The drugs are not recommended for patients with symptomatic heart failure; initiation of these drugs in patients with established NYHA class III or IV heart failure is contraindicated
- This medication contains Prialta. Do not take Actos if you are allergic to Prialta or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Mixing Prialta with herbal remedies and supplements
There's very little information about taking herbal remedies or supplements with Prialta.
Actos (Prialta) is a drug prescribed for the treatment of type 2 diabetes. Side effects include:
Drug interactions, warnings and precautions, and pregnancy and breastfeeding information should be reviewed prior to taking this medication.
How is this medicine (Prialta) best taken?
Use Prialta as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- To gain the most benefit, do not miss doses.
- Keep taking Prialta as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
- Skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
Common Side Effects of Prialta
Tell your doctor if any of the following side effects become severe or don't go away:
- Sore throat
- Muscle pain
- Sinus pain
- Weight gain
- Tooth problems
- Pain in the arms or legs
Prialta and breastfeeding
Prialta isn't usually recommended while breastfeeding. There isn't any information to say whether it's safe or not.
Your doctor will probably recommend a different diabetes medicine while you're breastfeeding.
Common (1% to 10%): Fractures, myalgia, pain in extremity, back pain, cramped legs, arthralgia
In the prospective Prialta clinical trial in macrovascular events (PROactive), the incidence of bone fractures in female patients with this drug was 5.1% (44/870) compared to 2.5% (23/905) for placebo treated patients. The majority of fractures were nonvertebral including lower limb and distal upper limb. The incidence in men was 1.7% and no different than placebo (2.1%).