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Actoplus Side Effects

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Common Actoplus Side Effects


The most commonly reported Actoplus side effects (click to view or check a box to report):

Bladder Cancer (29)
Blood Glucose Increased (12)
Blood Glucose Decreased (12)
Dyspnoea (11)
Myalgia (11)
Fall (10)
Myocardial Infarction (10)
Incorrect Dose Administered (9)
Muscular Weakness (9)
Weight Increased (8)
Asthenia (8)
Fatigue (8)
Nausea (7)
Malaise (6)
Oedema Peripheral (6)
Dizziness (6)
Cardiac Failure Congestive (6)
Weight Decreased (6)
Anxiety (6)
Chest Pain (6)

➢ 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.

Actoplus Side Effects Reported to FDA



Actoplus Side Effect Report#9357238
Bladder Transitional Cell Carcinoma
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Actoplus Met (dosage: 2 In 1, start time: 2005), combined with:
  • Colcrys (colchicine)
  • Vytorin (simvastatin, Ezetimibe)
  • Lovaza (omega-3 Marine Triglycerides)
  • Aspirin (acetylsalicylic Acid)
  • Celebrex (celecoxib)
and developed a serious reaction and side effect(s): Bladder Transitional Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus Met treatment in male patients, resulting in Bladder Transitional Cell Carcinoma side effect.
Actoplus Side Effect Report#9294208
Blood Glucose Increased, Product Substitution Issue, No Therapeutic Response
This report suggests a potential Actoplus Met Blood Glucose Increased side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actoplus Met (dosage: 15/850;1 Bid; Oral) starting 2008. After starting Actoplus Met the patient began experiencing various side effects, including: Blood Glucose Increased, Product Substitution Issue, No Therapeutic ResponseAdditional drugs used concurrently: NA. Although Actoplus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Glucose Increased, may still occur.
Actoplus Side Effect Report#9293110
Bladder Cancer
This Bladder Cancer problem was reported by a physician from US. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On 200708 this consumer started treatment with Actoplus Met (pioglitazone Hydrochloride, Metformin Hydrochloride) (dosage: NA). The following drugs were being taken at the same time:
  • Metformin (metformin)
  • Starlix (nateglinide) Tablet
  • Lantus (insulin Glargine)
  • Januvia (sitagliptin Phosphate)
  • Avandamet (metformin Hydrochloride, Rosiglitazone Maleate)
When using Actoplus Met (pioglitazone Hydrochloride, Metformin Hydrochloride), the patient experienced the following unwanted symptoms/side effects: Bladder CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actoplus Side Effect Report#9288425
Metastases To Lymph Nodes, Hydronephrosis, Urinary Tract Obstruction, Transitional Cell Carcinoma
This Metastases To Lymph Nodes side effect was reported by a pharmacist from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actoplus (drug dosage: NA), which was initiated on 2007. Concurrently used drugs:
  • Sitagliptin
  • Lisinopril
  • Simvastatin
.After starting to take Actoplus the consumer reported adverse symptoms, such as: Metastases To Lymph Nodes, Hydronephrosis, Urinary Tract Obstruction, Transitional Cell CarcinomaThese side effects may potentially be related to Actoplus. The patient was hospitalized and became disabled.
Actoplus Side Effect Report#9189342
Bladder Cancer, Metastases To Bone
This is a report of a 48-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Actoplus Met (pioglitazone Hydrochloride, Metformin Hydrochloride) (dosage: NA, start time:
Oct 19, 2006), combined with:
  • Actos (piogltazone Hydrochloride)
and developed a serious reaction and side effect(s): Bladder Cancer, Metastases To Bone after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus Met (pioglitazone Hydrochloride, Metformin Hydrochloride) treatment in male patients, resulting in Bladder Cancer side effect.
Actoplus Side Effect Report#9167801
This report suggests a potential Actoplus Met Death side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actoplus Met (dosage: NA) starting NS. After starting Actoplus Met the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Actoplus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Actoplus Side Effect Report#9162547
Bladder Cancer
This Bladder Cancer problem was reported by a health professional from US. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On 2006 this consumer started treatment with Actoplus Met (pioglitazone Hydrochloride, Metformin Hydrochloride) (dosage: NA). The following drugs were being taken at the same time: NA. When using Actoplus Met (pioglitazone Hydrochloride, Metformin Hydrochloride), the patient experienced the following unwanted symptoms/side effects: Bladder CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actoplus Side Effect Report#9034666
Bladder Cancer
This Bladder Cancer side effect was reported by a consumer or non-health professional from US. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actoplus Met (pioglitazone Hydrochloride,metformin Hydrochloride) (drug dosage: NA), which was initiated on
Aug 10, 2009. Concurrently used drugs: NA..After starting to take Actoplus Met (pioglitazone Hydrochloride,metformin Hydrochloride) the consumer reported adverse symptoms, such as: Bladder CancerThese side effects may potentially be related to Actoplus Met (pioglitazone Hydrochloride,metformin Hydrochloride).
Actoplus Side Effect Report#8932563
Fatigue, Malaise, Hepatic Cancer
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Actoplus (dosage: NA, start time: NS), combined with:
  • Actos (pioglitazone Hydrochloride)
and developed a serious reaction and side effect(s): Fatigue, Malaise, Hepatic Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus treatment in male patients, resulting in Fatigue side effect.
Actoplus Side Effect Report#8856282
Bladder Cancer
This report suggests a potential Actoplus Met Bladder Cancer side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Actoplus Met (dosage: NA) starting 2004. After starting Actoplus Met the patient began experiencing various side effects, including: Bladder CancerAdditional drugs used concurrently:
  • Actos (pioglitazone Hydrochloride)
  • Januvia (sitagliptin Phosphate)
  • Glimepiride (glimepiride)
  • Coumadin (warfarin Sodium)
  • Lipitor (atorvastatin Calcium)
  • Losartan (losartan)
  • Topral Xl (metoprolol Succinate)
  • Synthroid (levothyroxine Sodium)
Although Actoplus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bladder Cancer, may still occur.
Actoplus Side Effect Report#8764233
Bladder Cancer
This Bladder Cancer problem was reported by a physician from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus,bladder cancer. On 2008 this consumer started treatment with Actoplus Met (dosage: NA). The following drugs were being taken at the same time: NA. When using Actoplus Met, the patient experienced the following unwanted symptoms/side effects: Bladder CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actoplus Side Effect Report#8756048
Bladder Cancer, Renal Failure, Cardiac Failure Congestive
This Bladder Cancer side effect was reported by a health professional from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actoplus Met (drug dosage: NA), which was initiated on 2004. Concurrently used drugs:
  • Metformin (metformin)
  • Avandia (rosiglitazone Maleate)
  • Januvia (sitagliptin Phosphate)
.After starting to take Actoplus Met the consumer reported adverse symptoms, such as: Bladder Cancer, Renal Failure, Cardiac Failure CongestiveThese side effects may potentially be related to Actoplus Met.
Actoplus Side Effect Report#8258754-2
Bladder Cancer
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Actoplus Met (dosage: One Tablet, start time:
Oct 08, 2007), combined with: NA. and developed a serious reaction and side effect(s): Bladder Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus Met treatment in male patients, resulting in Bladder Cancer side effect.
Actoplus Side Effect Report#8258751-7
Bladder Cancer
This report suggests a potential Actoplus Met Bladder Cancer side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actoplus Met (dosage: One Tablet) starting
Oct 08, 2007. After starting Actoplus Met the patient began experiencing various side effects, including: Bladder CancerAdditional drugs used concurrently: NA. Although Actoplus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bladder Cancer, may still occur.
Actoplus Side Effect Report#8254688-8
Bladder Cancer
This Bladder Cancer problem was reported by a physician from United States. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Actoplus Met (dosage: 15/850 Mg, 2 In 1 D). The following drugs were being taken at the same time: NA. When using Actoplus Met, the patient experienced the following unwanted symptoms/side effects: Bladder CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actoplus Side Effect Report#8200362-3
Hypersensitivity, Sinusitis, Incorrect Dose Administered, Blood Glucose Increased
This Hypersensitivity side effect was reported by a health professional from United States. A male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actoplus Met (drug dosage: NA), which was initiated on
Aug 01, 2011. Concurrently used drugs:
  • Egrifta
  • Egrifta
.After starting to take Actoplus Met the consumer reported adverse symptoms, such as: Hypersensitivity, Sinusitis, Incorrect Dose Administered, Blood Glucose IncreasedThese side effects may potentially be related to Actoplus Met. The patient was hospitalized.
Actoplus Side Effect Report#8168392-8
Blood Glucose Abnormal, Renal Disorder, Volvulus, Renal Impairment
This is a report of a 64-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Actoplus Met (dosage: NA, start time:
Jan 01, 2009), combined with:
  • Januvia
  • Insulin
and developed a serious reaction and side effect(s): Blood Glucose Abnormal, Renal Disorder, Volvulus, Renal Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus Met treatment in female patients, resulting in Blood Glucose Abnormal side effect.
Actoplus Side Effect Report#8168274-1
Bladder Cancer
This report suggests a potential Actoplus Met Bladder Cancer side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Actoplus Met (dosage: NA) starting
Jan 01, 2005. After starting Actoplus Met the patient began experiencing various side effects, including: Bladder CancerAdditional drugs used concurrently: NA. Although Actoplus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bladder Cancer, may still occur.
Actoplus Side Effect Report#8168272-8
Bladder Cancer
This Bladder Cancer problem was reported by a consumer or non-health professional from United States. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jan 01, 1999 this consumer started treatment with Actoplus Met (dosage: NA). The following drugs were being taken at the same time: NA. When using Actoplus Met, the patient experienced the following unwanted symptoms/side effects: Bladder CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Actoplus Side Effect Report#8156635-6
Bladder Cancer
This Bladder Cancer side effect was reported by a health professional from United States. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actoplus Met (drug dosage: Bid, 15 Mg/850 Mg, Per Oral), which was initiated on
Jun 01, 2009. Concurrently used drugs: NA..After starting to take Actoplus Met the consumer reported adverse symptoms, such as: Bladder CancerThese side effects may potentially be related to Actoplus Met. The patient was hospitalized.
Actoplus Side Effect Report#8073501-5
Bladder Cancer
This is a report of a 56-year-old patient (weight: NA) from United States, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Actoplus Met (dosage: 15/850, 2 In 1 D, Per Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Bladder Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus Met treatment in patients, resulting in Bladder Cancer side effect.
Actoplus Side Effect Report#8065128-6
Bladder Cancer, Abdominal Pain
This report suggests a potential Actoplus Met Bladder Cancer side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Actoplus Met (dosage: Bid, 15/500 Mg, Per Oral) starting
Jan 01, 2008. After starting Actoplus Met the patient began experiencing various side effects, including: Bladder Cancer, Abdominal PainAdditional drugs used concurrently: NA. Although Actoplus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bladder Cancer, may still occur.
Actoplus Side Effect Report#8062287-6
Muscle Swelling
This Muscle Swelling problem was reported by a consumer or non-health professional from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus,blood cholesterol abnormal,hypertension. On
Oct 01, 2011 this consumer started treatment with Actoplus Met (dosage: Unk). The following drugs were being taken at the same time:
  • Simvastatin (Unk)
  • Benazepril Hydrochloride (20 Mg, Daily)
  • Norvasc (5 Mg, Daily)
When using Actoplus Met, the patient experienced the following unwanted symptoms/side effects: Muscle SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Swelling, may become evident only after a product is in use by the general population.
Actoplus Side Effect Report#7980327-7
Procedural Site Reaction, Infection, Abdominal Hernia, Post Procedural Complication, Cholelithiasis
This Procedural Site Reaction side effect was reported by a consumer or non-health professional from United States. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actoplus Met (drug dosage: 15 Mg/850 Mg Qd, Per Oral), which was initiated on NS. Concurrently used drugs:
  • Naproxen
  • Vicodin
  • Lisinopril
  • Fluocinolone Cream (fluocinolone Acetonide)
  • Proair Inhaler (fluticasone Propionate)
  • Flomax
.After starting to take Actoplus Met the consumer reported adverse symptoms, such as: Procedural Site Reaction, Infection, Abdominal Hernia, Post Procedural Complication, CholelithiasisThese side effects may potentially be related to Actoplus Met. The patient was hospitalized.
Actoplus Side Effect Report#7972518-6
Bladder Cancer
This is a report of a 79-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Actoplus Met (dosage: 15 Mg /500 Mg, 2 In 1 D, Per Oral, start time:
Jan 01, 2007), combined with: NA. and developed a serious reaction and side effect(s): Bladder Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actoplus Met treatment in female patients, resulting in Bladder Cancer side effect.


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The appearance of Actoplus 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.

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.

    Actoplus 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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    Actoplus Safety Alerts, Active Ingredients, Usage Information

    NDC54868-5500
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameActoplus Met
    Namepioglitazone hydrochloride and metformin hydrochloride
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20060104
    LabelerPhysicians Total Care, Inc.
    Active Ingredient(s)METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
    Strength(s)500; 15
    Unit(s)mg/1; mg/1
    Pharma ClassPeroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist

    More About Actoplus

    Side Effects reported to FDA: 173

    Actoplus safety alerts: 2007

    Reported deaths: 15

    Reported hospitalizations: 57

    ACTOplus met (pioglitazone and metformin hydrochloride)

    Audience: Endocrinologists, other healthcare professionals, consumers

    [Posted 03/09/2007] Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.

    [March 2007 - Letter - Takeda Pharmaceuticals North America, Inc.]

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