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OFF LABEL USE and Metformin

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OFF LABEL USE Symptoms and Causes

Normally, your cells grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy is drug therapy for cancer. It works by killing the cancer cells, stopping them from spreading, or slowing their growth. However, it can also harm healthy cells, which causes side effects.

You may have a lot of side effects, some, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts. Some common side effects are fatigue, nausea, vomiting, pain, and hair loss. There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

Your treatment plan will depend on the cancer type, the chemotherapy drugs used, the treatment goal, and how your body responds. Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells. You might take the drugs by mouth, in a shot, as a cream, or intravenously (by IV).

NIH: National Cancer Institute

Check out the latest treatments for OFF LABEL USE

OFF LABEL USE treatment research studies

Metformin clinical trials, surveys and public health registries


Find Drug Side Effect reports



Metformin Side Effects

Lactic Acidosis (2533)
Renal Failure Acute (1526)
Diarrhoea (990)
Vomiting (735)
Blood Glucose Increased (635)
Hypotension (588)
Nausea (587)
Haemodialysis (566)
Hypoglycaemia (554)
Completed Suicide (515)
Metabolic Acidosis (488)
Abdominal Pain (385)
Dehydration (375)
Renal Failure (366)
Cardiac Arrest (346)
Dyspnoea (333)
Malaise (311)
Toxicity To Various Agents (287)
Hyperkalaemia (276)
Dizziness (259)
Overdose (258)
Renal Impairment (256)
Blood Creatinine Increased (235)
Asthenia (233)
Intentional Overdose (229)
Suicide Attempt (227)
Confusional State (213)
Fatigue (212)
Myocardial Infarction (207)
Weight Decreased (196)
Decreased Appetite (183)
Hypothermia (179)
Headache (177)
Abdominal Pain Upper (177)
Pancreatitis Acute (175)
Blood Glucose Decreased (163)
Pain (161)
Shock (159)
Continuous Haemodiafiltration (157)
Multi-organ Failure (153)
Abdominal Discomfort (153)
Somnolence (149)
Fall (149)
Agitation (148)
Diabetes Mellitus Inadequate Control (145)
Loss Of Consciousness (143)
Pancreatitis (137)
Pneumonia (126)
Poisoning (125)
Hypertension (120)

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Common Meds

Abilify (10132)
Adderall (1304)
Amlodipine (6664)
Amoxicillin (4387)
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Cipro (8580)
Citalopram (7792)
Crestor (18839)
Cymbalta (14373)
Doxycycline (1757)
Effexor (7289)
Flexeril (435)
Flomax (2177)
Fluoxetine (4261)
Gabapentin (4593)
Hydrocodone (2469)
Ibuprofen (8222)
Lantus (10968)
Lexapro (3499)
Lipitor (17769)
Lisinopril (8919)
Lyrica (27148)
Medrol (650)
Mirena (41254)
Mobic (957)
Morphine (5356)
Naproxen (538)
Neurontin (6501)
Oxycodone (4438)
Pradaxa (13372)
Prednisone (5926)
Prilosec (2631)
Prozac (1954)
Seroquel (27216)
Simvastatin (8348)
Synthroid (4452)
Tamiflu (5585)
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Tramadol (5054)
Trazodone (1458)
Viagra (5394)
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Wellbutrin (6324)
Xanax (2847)
Zocor (5718)
Zoloft(6792)
Zyrtec(1669)

Recent Reviews

At what age should stop taking this drug?

Been on metformin for 4 days so far for Pcos and have eaten it with food and i am having sever diahrea and cramps. i have to take 500mg once a day for 2 weeks and then 2 times a day for 2 weeks and then 3 times a day and i dunno how to make

Bleeding gums

By using the medicine for 3 months,there was symptoms of impotency.

Coma causing motor cycle accident. brain damage. family difficulties not being able to work causing financial problems

Ever since I started taking Metformin almost a year now, I have had a cough and it will not go away.

Fatigue severe pain down left arm dizziness shortness of breath palputations and shere lack of get up and go

Feeling nervous

Feeling sleepy, fatigue, and tiredall the time. My vision is also gone seriously blurred.

Got up this morning and I was covered with a rash much like poisen ivy, and very itchy. Also my eyes were almost swelled shut. and the bag part under my eyes was full of fluid. Quit the Med formin immedietly and seem bet

45 yr old male, went to dentist had a lot of calc buildup, gave me peridex, told me it might be a little strong might need to cut it down or test it first, he gave this to me, I didnt read the label or anything I thought it was just a mouthwash WARNI

Anthony, thank you. I thought I was going nuts. Weight gain would be an understatement. Bloating and gas too. Not sure I want to continue this and I have not been on the 'full' dose --- misread the label and am happy I d

Hi i need information toward somatropin label price?

I had a devastating experience with this drug. I had been using Flexeril for back and neck pain but found it no longer as effective. I asked my doctor if there was something stronger. He prescribed Baclofen. Having not read the label carefully, m

I have been on 20 mg of Cipralex for over 3 years. It does it's job and I do not experience anxiety. In doing your homework, you will see Cipralex is for anxiety which is part of the 'depression' family. One does not label the other. One of the bigg

I have been sick with allergies/asthma/sinusitis for over a week and when I took Mucinex DM I made sure to read the label carefully. My carton said to take 1 every 12 hours and no more than 2 in 24 hours. After taking the first pill it had no effect

I haven't had an abortion induced but the medicine label clearly states to use two forms of protection. If the patient has unprotected sex, that the patient's problem. Every doctor visit my doctor stressed to me how much the medicine could

I may try Lyrica off label for GAD and PD as well as some antidepressive effects I read in journals, articles. Lyrica has been approved for GAD in Europe but hasn't gotten the FDA approval for it here yet. The above poster, Case Report #Self-49

I take Centrum Silver and wanted a label that I could read.

Is a GG 40 with a Sandoz label made in a different laboratory than a GG 40 with a Geneva label? (I know they are both 10 mg of amitriptyline.) Thank you. Appreciate reply as soon as possible.

OFF LABEL USE Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Rank Status Study
1 Recruiting Influence of the Use of the Diabetic Drug Metformin on the Overall Survival and Treatment-related Toxicity in Advanced Stage Non-small Cell Lung Cancer Patients.
Condition: Non Small Cell Lung Cancer
Intervention:
Outcome Measures: Assessment of Metformin use;   Assessment of insulin use;   Overall assessment of overall survival and toxicity factors
2 Recruiting Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Metformin IR;   Drug: Saxagliptin;   Drug: Saxagliptin/Metformin XR FDC;   Drug: Metformin XR
Outcome Measures: Maximum observed plasma concentration (Cmax) of Saxagliptin;   Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin;   Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin;   Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin;   Maximum observed plasma concentration (Cmax) of Metformin;   Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin;   Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin;   Safety: based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests;   Formulation swallowability of Saxagliptin-Metformin FDC tablet, Glucophage® IR tablet and Glucophage® XR tablet
3 Not yet recruiting Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Low Metformin;   Drug: Metformin;   Drug: Mid Metformin;   Drug: High Metformin
Outcome Measures: Change In Fasting Plasma Glucose;   Gastrointestinal Effects;   Change in Baseline-Corrected Plasma Glucose and Insulin Area Under The Concentration Curves;   Change in Insulin Secretory Rates;   Change in Fasting Plasma Lipids;   Change in HbA1c;   Change in HOMA-IR;   Change In 7-Point Glucose Profiles;   Change In Serial Blood Glucose Concentrations;   Safety and Tolerability
4 Unknown  Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Conditions: Obesity;   Weight Gain;   Psychotropic Induced Weight Gain
Intervention: Drug: Metformin
Outcome Measures: Change in weight;   Weight trajectory based on length of intervention and factors that predict response to Metformin
5 Recruiting PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent;   Hypertriglyceridemia
Interventions: Drug: Metformin Eicosapentaenoate;   Drug: Metformin HCl and Vascepa
Outcome Measure: AUC following single and repeat single oral administration of Metformin eicosapentaenoate, Metformin hydrochloride and Vascepa
6 Recruiting Study of Metformin With Simvastatin for Men With Prostate Carcinoma
Condition: Prostate Carcinoma
Interventions: Drug: Metformin;   Drug: Simvastatin
Outcome Measures: Efficacy, as measured by an improvement in PSA doubling time (PSADT) between baseline and 6 months, of the combination of Metformin plus simvastatin in patients with recurrent prostate cancer following definitive treatment.;   Time to protocol-specified event for men treated with the combination of Metformin plus simvastatin.;   Pattern of change in log PSA levels and PSA velocity over time during treatment with Metformin plus simvastatin.;   Associations between changes in metabolic parameters (fasting glucose/insulin/lipid panel/leptin/adiponectin and others) with the pattern of change in log PSA levels.
7 Recruiting Efficacy and Safety of Alogliptin and Metformin Fixed-dose Combination in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin;   Drug: Metformin HCl;   Drug: Alogliptin and Metformin fixed-dose combination (FDC);   Drug: Alogliptin placebo;   Drug: Metformin placebo;   Drug: Alogliptin and Metformin FDC placebo
Outcome Measures: Change From Baseline to Week 26 (or Early Termination) in Glycosylated Hemoglobin (HbA1c);   Change From Baseline in HbA1c Over Time;   Change From Baseline in Fasting Plasma Glucose Over Time;   Time to hyperglycemic rescue event;   Percentage of Participants Meeting Rescue Criteria;   Percentage of Participants With Marked Hyperglycemia;   Change From Baseline in Body Weight Over Time;   Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%;   Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%;   Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%;   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%;   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%;   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%;   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%
8 Recruiting Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects.
Condition: Healthy
Interventions: Drug: Linagliptin;   Drug: Metformin;   Drug: Linagliptin/Metformin FDC
Outcome Measures: Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72);   Maximum measured concentration of linagliptin in plasma (Cmax);   Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz);   Cmax of Metformin in plasma;   Area under the concentration-time curve of linagliptin and Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf);   AUC0-inf of Metformin in plasma
9 Recruiting Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Metformin XR;   Drug: Metformin IR;   Drug: Placebo matching with Metformin XR;   Drug: Placebo matching with Metformin IR
Outcome Measures: Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24;   Mean change in fasting plasma glucose (FPG) from baseline to Week 24;   Mean change in Mean Daily Glucose (MDG) from baseline to Week 24;   Percent of subjects with HbA1c <7%
10 Recruiting Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Condition: Polycystic Ovary Syndrome
Intervention: Drug: Metformin
Outcome Measures: Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy;   Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy
11 Recruiting A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer
Condition: Metastatic Pancreatic Adenocarcinoma
Interventions: Drug: Metformin alone (Arm A);   Drug: Metformin (Arm B);   Drug: rapamycin (Arm B)
Outcome Measure: safety and feasibility
12 Recruiting Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis
Conditions: Polycystic Ovary Syndrome;   Disorder of Glucose Regulation
Interventions: Drug: Metformin XR;   Drug: Saxagliptin;   Drug: Saxagliptin-Metformin XR
Outcome Measures: Fasting and 2 hour glucose levels after glucose load;   ß-cell compensatory function;   Surrogate measures of insulin sensitivity and secretion;   Cardiometabolic risk factors;   Free androgen index
13 Recruiting Bioequivalence of a Low, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects
Condition: Healthy
Interventions: Drug: Linagliptin;   Drug: Linagliptin/Metformin ER FDC;   Drug: Metformin ER
Outcome Measures: Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72);   Maximum measured concentration of linagliptin in plasma (Cmax);   Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz);   Cmax of Metformin in plasma;   Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf);   AUC0-inf of Metformin in plasma
14 Recruiting Bioequivalence of a High, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects
Condition: Healthy
Interventions: Drug: Linagliptin/Metformin ER FDC;   Drug: Linagliptin;   Drug: Metformin ER
Outcome Measures: Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72);   Maximum measured concentration of linagliptin in plasma (Cmax);   Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz);   Cmax of Metformin in plasma;   Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf);   AUC0-inf of linagliptin in plasma
15 Recruiting Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects
Condition: Healthy
Interventions: Drug: Metformin;   Drug: BI 187004
Outcome Measures: AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004;   AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for Metformin;   Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004;   Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for Metformin
16 Recruiting Metformin for the Treatment of Endometrial Hyperplasia
Conditions: Endometrial Hyperplasia;   Endometrial Hyperplasia Without Atypia
Intervention: Drug: Metformin
Outcome Measures: Response Rate;   Toxicity evaluation;   Patient Compliance;   Potential molecular markers in response to treatment with Metformin
17 Not yet recruiting A Study With or Without Metformin to Determine if Metformin Can Prevent Weight Gain and Other Problems (i.e. Diabetes, Increased Cholesterol, Etc.) That Can Arise From the Use of Hormonal Therapy in Combination With Radiation Therapy When Treating Aggressive Localized Prostate Cancer.
Condition: Prostatic Neoplasm
Interventions: Drug: Metformin;   Drug: Placebo
Outcome Measures: Mean body weight at 12 months of follow-up;   Prevalence and incidence of Metabolic Syndrome
18 Recruiting Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Condition: Breast Cancer Prevention
Interventions: Drug: Metformin;   Drug: Placebo
Outcome Measures: change from baseline in breast density at 6 and 12 months;   change from baseline in serum insulin levels at 6 and 12 months;   change from baseline in serum IGF-1 to IGFBP-3 ratio at 6 and 12 months;   change from baseline in serum testosterone levels at 6 and 12 months;   change from baseline in serum leptin to adiponectin ratio at 6 and 12 months;   change from baseline in body weight at 6 and 12 months;   change from baseline in waist circumference at 6 and 12 months;   change from baseline in serum IGF-2 levels at 6 and 12 months
19 Not yet recruiting The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
Conditions: Diabetes Mellitus, Type 2;   Diabetes
Interventions: Drug: Metformin;   Drug: Detemir;   Drug: Liraglutide;   Drug: Insulin Aspart
Outcome Measures: Composite end-point;   Mean change from randomization in A1c at week 26;   Percentage of patients reaching target A1c of <7% at week 26;   Percentage of patients reaching pre-specified "treatment failure" outcome;   Mean change from randomization in body weight;   Percentage of patients who lost 5% or more of body weight from randomization;   Hypoglycemic episodes;   Percentage of patients experiencing any hypoglycemic episode;   Diabetes Quality of Life (DQOL)questionnaire score;   Short Form-36 (SF-36) questionnaire score;   Number of daily injections;   Health care cost, total;   Health care cost, diabetes-related;   Number of titration events by healthcare professional;   Number of titration events by patient;   Healthcare provider time during scheduled office (minutes/visit);   Healthcare provider time, unscheduled (total minutes);   Compliance with pharmacologic therapy;   Change in LDL cholesterol from baseline to week 26;   Change in triglycerides from baseline;   7-point glucose profiles over 2 consecutive days
20 Recruiting Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
Condition: Hormone Receptor Positive Malignant Neoplasm of Breast
Interventions: Drug: Metformin;   Drug: Placebo
Outcome Measures: Clinical response rate;   Pathologic complete response rate;   Changes of Ki67(%);   Breast conservation rate;   Breast density change;   Toxicity profile of letrozole and Metformin