OFF LABEL USE and Metronidazole

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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

➢ Metronidazole clinical trials, surveys and public health registries

Find Drug Side Effect reports

Metronidazole Side Effects

Dysarthria (124)

Dizziness (124)

Vomiting (119)

Nausea (108)

Encephalopathy (106)

Diarrhoea (102)

Paraesthesia (93)

Headache (88)

Confusional State (80)

Ataxia (80)

Toxic Encephalopathy (71)

Pruritus (67)

Gait Disturbance (62)

Neuropathy Peripheral (60)

Pain (60)

Pyrexia (58)

Cerebellar Syndrome (58)

Rash (56)

Urticaria (51)

Malaise (49)

Neurotoxicity (44)

Anaphylactic Reaction (44)

Abdominal Pain (43)

Dyspnoea (42)

Anxiety (41)

Dysgeusia (41)

International Normalised Ratio Increased (39)

Asthenia (38)

Hypoaesthesia (37)

Fatigue (37)

Convulsion (34)

Somnolence (34)

Nuclear Magnetic Resonance Imaging Brain Abnormal (32)

Pain In Extremity (31)

Coordination Abnormal (31)

Arthralgia (31)

Abdominal Pain Upper (30)

Balance Disorder (30)

Clostridium Difficile Colitis (30)

Depression (30)

Chest Pain (30)

Cerebellar Ataxia (29)

Insomnia (28)

Dysphagia (27)

Condition Aggravated (27)

Feeling Abnormal (27)

Psychotic Disorder (27)

Nystagmus (26)

Liver Function Test Abnormal (26)

Muscular Weakness (25)

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Recent Reviews

<b>Describe Your Metronidazole Experience Here:</b> after taking a total of 4 pills, 1 first day 2 second day and 1 in third day. I had symptoms begin on that second day. There was tingling in my lips with burning in my lips and tongue. T

Can I take Flagyl for a UTI?

Dentist gave me 400mg of metronidazole for toothache i feel sick and dizzy i keep going hot and cold and my skin goes red

Diagnosed with BV and started taking Flagyl orally twice per day for 7 days. In the 4th day of my treatment my period started. Had very heavy flow. No cramps but very heavy menstrual bleeding and passed large blood clots

Diahorrea, metallic taste in the mouth, burning vagina feeling sick bad stomach

Experienced palpitation

Hi just been discharged from A&E. Meronidazeole 400mg. I had severe racing heart beats (resting pulse normally 53 became 90-100! and would go to 140 with no prompting). Blood pressure usually 120/60 became 135/90>. Breathing was di

Hi,am 21 years old from phil. am engaging sex so many times for ten guys,time came that am discharging something unpleasant and yellow in color am shy to check a doctor so i just try to search some knowledge on net then am trying using metronidazole

I am a 18 yr old, i was pescribed metro for a infection.... 2 days into i was feeling very paranoid and frightened, last night i experienced two encounters of wide awake, shaking, grunting, crying and coldness. scareyyy :'(

I am deeply indebted to Danny Smith with his comments about metronidazole. I was also prescribed metronidazole for a tooth complaint and after experiencing dizziness and being very unwell with nausea, happened to find his remarks on the net. A

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

Recruiting

Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

Conditions:	Abnormal Vaginal Flora; Clindamycin Vs Metronidazole; High Risk Pregnancies for Preterm Labor
Interventions:	Drug: Clindamycin; Drug: Metronidazole
Outcome Measures:	To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora; The prevalence of adverse effects; The prevalence of late abortions and preterm deliveries; Assessing the correlation between Nugent score , physical examination and Ph indicators

Recruiting

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease

Condition:	Crohn's Disease
Interventions:	Drug: Azithromycin + Metronidazole; Drug: Metronidazole
Outcome Measures:	Response rate at 8 weeks defined as a drop in PCDAI (Pediatric Crohn's Disease Activity Index ) of at least 12.5 points (or remission without steroids, intention to treat principle); Normalization of CRP ( CRP ≤0.5 mg/dL).; Fecal calprotectin at 8 weeks .

Not yet recruiting

Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.

Condition:	Bacterial Infections
Interventions:	Drug: Metronidazole benzoate; Drug: Flagyl 125 mg/5 ml oral suspension; Drug: Flagyl 400 mg Tablets
Outcome Measures:	Plasma concentration time profiles under the curve (AUC); Maximum concentration (Cmax); Time to maximum concentration (Tmax); Elimination rate constant (Kel); Terminal half life (t1/2); Number of participants with Adverse Events

Recruiting

BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study

Condition:	Bacterial Vaginosis
Interventions:	Drug: Gelatin; Drug: Boric acid; Drug: Metronidazole
Outcome Measures:	Effectiveness of treatment of intravaginal boric acid and Metronidazole at 1 week and 30 days post-treatment will be measured as absence of symptoms or negative vaginal swab (Nugent score less than 7) if symptoms are present for BV.; If during the 10 days of treatment of intravaginal boric acid and Metronidazole the patient discontinues the treatment because of side effects or complained of intolerable side effects this will be considered a treatment failure for safety.

Unknown ^†

Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy

Condition:	Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Interventions:	Drug: 10RAC+acetylcystein; Drug: 10RAC+Metronidazole
Outcome Measures:	Re-eradication rate; Influence of Participant's CYP2C19 genotype on re-eradication rate

Unknown ^†

Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses

Condition:	Abscess, Intra-Abdominal
Intervention:	Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
Outcome Measures:	Clinical success / failure rate at the Test-of-Cure visit; Clinical + Bacteriological response at End-of-Treatment-visit; Time to discharge from hospital; Course of disease on the basis of clinical and laboratory parameters; safety and tolerability of the study medication; cost effectiveness of treatment regimes

Recruiting

Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

Condition:	Complicated Intra-Abdominal Infection
Interventions:	Drug: CAZ-AVI; Drug: Metronidazole; Drug: Meropenem
Outcome Measures:	Clinical Cure as Measured by proportion of patients meeting cure criteria in the microbiological modified Intent-To-Treat analysis set.; The proportion of patients with clinical cure in the microbiologically evaluable and extended microbiologically evaluable analysis set; The proportion of patients with clinical cure in the microbiological modified intent-to-treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets; The proportion of patients with clinical cure in the clinically evaluable analysis set.; The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets; The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets; The favorable per-pathogen microbiologic response by minimum inhibitory concentration (MIC) categories in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets; Favorable per-patient clinical response & microbiological response for patients infected with ceftazidime-resistant pathogens in microbiological modified intent to treat, microbiologically evaluable & extended microbiologically evaluable analysis sets; Proportion of patients with favorable per-pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in microbiological modified ITT, microbiologically evaluable and extended microbiologically evaluable analysis sets; The time to first defervescence in the clinically evaluable, microbiologically evaluable, and extended microbiologically evaluable analysis sets for patients who have fever at study entry; The safety and tolerability by incidence and severity of adverse events and serious adverse events, vital signs, clinical laboratory tests, ECGs and physical exams.; Pharmacokinetics: maximum concentration (Cmax), minimum concentration, area under the plasma concentration time curve at steady state, and terminal half-life

Recruiting

Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Condition:	Bacterial Vaginosis
Interventions:	Drug: N-Acetyl cysteine; Drug: Metronidazole + N-Acetyl cysteine; Drug: Metronidazole
Outcome Measures:	recovery of BV; prevention of recurrence

Recruiting

Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections

Condition:	Complicated Intra-abdominal Infection
Interventions:	Drug: Ceftazidime-avibactam; Drug: Metronidazole; Drug: Meropenem
Outcome Measures:	The proportion of patients with clinical cure in the clinically evaluable analysis set; The proportion of patients with clinical cure in the microbiologically evaluable, extended microbiologically evaluable and microbiological modified intent-to-treat analysis sets; The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets; The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets; The favorable per-pathogen microbiologic response by minimum inhibitory concentration categories in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets; Favorable clinical response and favorable per-patient microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and (extended) microbiologically evaluable analysis sets; The proportion of patients with a favorable per-pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and (extended) microbiologically evaluable analysis sets; The time to first defervescence in the clinically evaluable, microbiologically evaluable and extended microbiologically evaluable analysis sets for patients who have fever at study entry; Safety and tolerability by incidence and severity of adverse events and serious adverse events, exposure, mortality, reasons for discontinuations of study therapy, vital signs, laboratory tests, electrocardiogram parameters and physical exams

Unknown ^†

Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.

Conditions:	Chronic Periodontitis; Clinical and Microbiological Effects
Intervention:	Drug: Administration of Metronidazole plus Amoxicillin
Outcome Measures:	- Mean change in clinical attachment level (CAL); - Mean change in probing pocket depths (PD)

Recruiting

Impact of Oral Antibiotic Treatment on C. Difficile

Conditions:	C. Difficile; Diarrhea; Enterocolitis
Interventions:	Drug: Fidaxomicin; Drug: Metronidazole; Drug: Vancomycin
Outcome Measures:	Change in variation of the profile of C. difficile isolated from specific body sites of a patient with microbiology-proven CDAD; Change in variation in the profile of C. difficile isolated from targeted surfaces in a hospital; Extent and quantity of C. difficile shedding, colonization and environmental contamination in patients who received oral fidaxomicin vs. oral Metronidazole or vancomycin; Duration of diarrhea that were positive for CDAD

Recruiting

The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis

Condition:	Periodontal Pocket
Interventions:	Drug: Metronidazole gel; Procedure: ultrasonics; Procedure: erythritol; Drug: placebo
Outcome Measures:	Probing pocket Depth change; Bleeding on Probing change; Clinical Attachment level change

Unknown ^†

Inflammation and Treatment of Bacterial Vaginosis Near Term

Condition:	Bacterial Vaginosis
Interventions:	Drug: Metronidazole; Drug: Placebo
Outcome Measure:	Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha

Recruiting

Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

Condition:	Helicobacter Pylori Infection
Interventions:	Drug: pantoprazole, amoxicillin, clarithromycin, Metronidazole; Drug: pantoprazole, amoxicillin, clarithromycin, metronidzole
Outcome Measure:	Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

Unknown ^†

The Impact of Obesity on Nonsurgical Periodontal Therapy

Conditions:	Periodontitis; Periodontal Diseases; Obesity
Interventions:	Drug: Metronidazole; Drug: Placebo; Procedure: Scaling and root planning
Outcome Measures:	Probing depth; Attachment level

Recruiting

Antibiotic Safety (SCAMP)

Condition:	Complicated Intra Abdominal Infections
Interventions:	Drug: ampicillin and Metronidazole and gentamicin; Drug: ampicillin and gentamicin and clindamycin; Drug: gentamicin and Piperacillin- tazobactam; Drug: standard of care antibiotics and Metronidazole
Outcome Measures:	Death; Number of participants with therapeutic success at Day 30 and Day 90

Recruiting

Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)

Condition:	Postoperative Ileus
Interventions:	Drug: DAM; Drug: Normal Saline
Outcome Measures:	Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2.; Time to ready for discharge; Time to the first flatus; Comparison between the 2 groups of analgesics (morphine) dose; peritoneal exudate volume of 72 hours after operation; C reactive protein changes from baseline

Recruiting

Concomitant Therapy of H. Pylori

Condition:	Gastritis, Gastric Ulcer, and Duodenal Ulcer
Intervention:	Drug: amoxicillin, clarithromycin, Metronidazole, rabeprazole
Outcome Measure:	Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori

Recruiting

Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population

Conditions:	Vaginosis, Bacterial; Infertility; Miscarriage
Interventions:	Drug: Metronidazole; Drug: Placebo
Outcome Measures:	Biochemical Pregnancy Rate (Positive Pregnancy Test); Pregnancy Rate (Pregnancy Visible on Ultrasound); Miscarriage Rate (Loss of a Clinically Recognized Pregnancy); Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)

Recruiting

Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis

Condition:	Pancreatitis,Acute Necrotizing
Interventions:	Drug: cefoperazone + Metronidazole; Procedure: oral care by chlorhexidine gluconate; Procedure: enteral nutrition; Drug: Somatostatin; Drug: Meropenem
Outcome Measures:	pancreatic or peripancreatic infection; cost of management of SAP; Microbiology resistance