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Cotareg Side Effects

PatientsVille

Common Cotareg Side Effects


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

Hyponatraemia (22)
Renal Failure Acute (14)
Malaise (14)
Blood Creatinine Increased (11)
Diarrhoea (11)
Fall (11)
Hypokalaemia (11)
Dizziness (10)
Dehydration (10)
Fatigue (9)
Confusional State (9)
Hypotension (8)
Erythema (8)
Vomiting (7)
Pruritus (7)
Bradycardia (6)
Creatinine Renal Clearance Decreased (6)
Renal Failure (6)
Nausea (6)
Dyspnoea (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.

Cotareg Side Effects Reported to FDA



Cotareg Side Effect Report#9797856
Atrial Fibrillation
This is a report of a 78-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Cotareg (dosage: Unk Ukn, Unk, start time:
Nov 28, 2013), combined with:
  • Sintrom (1 Mg, Unk)
  • Sintrom (25 Mg, Unk)
  • Trastuzumab (600 Mg, Once In 3 Week)
  • Trastuzumab (600 Mg , Once In 3 Wk)
  • Trastuzumab (600 Mg, Once In 3 Week)
  • Trastuzumab (600 Mg , 1 In 3 Wkunk)
  • Lanoxin (Unk Ukn, Unk)
  • Durogesic (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Atrial Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in female patients, resulting in Atrial Fibrillation side effect. The patient was hospitalized.
Cotareg Side Effect Report#9779669
Renal Failure Acute, Diarrhoea, Nausea, Renal Tubular Disorder
This report suggests a potential Cotareg Renal Failure Acute side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Cotareg (dosage: Once Daily (qd)) starting
Sep 24, 2013. After starting Cotareg the patient began experiencing various side effects, including: Renal Failure Acute, Diarrhoea, Nausea, Renal Tubular DisorderAdditional drugs used concurrently:
  • Cisplatin (134.25 Mg, Unk)
  • Contramal (200 Mg, Qd)
  • Imovane (Once Daily)
  • Xanax
  • Iressa (250 Mg, Qd)
  • Doxycycline (100 Mg, Qd)
  • Bevacizumab (585 Mg, Unk)
  • Pemetrexed (895 Mg, Unk)
The patient was hospitalized. Although Cotareg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Cotareg Side Effect Report#9777383
Tubulointerstitial Nephritis, Renal Failure Acute
This Tubulointerstitial Nephritis problem was reported by a health professional from FR. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,lung adenocarcinoma. On
Oct 08, 2013 this consumer started treatment with Cotareg (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time:
  • Alimta (Unk Ukn, Unk)
  • Cisplatine (Unk Ukn, Unk)
When using Cotareg, the patient experienced the following unwanted symptoms/side effects: Tubulointerstitial Nephritis, Renal Failure AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tubulointerstitial Nephritis, may become evident only after a product is in use by the general population.
Cotareg Side Effect Report#9681907
Hypotension, Renal Failure Acute
This Hypotension side effect was reported by a health professional from Country Not Specified. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension,arthralgia.The patient was prescribed Cotareg (drug dosage: 1 Df, (160 Mg Vala/ Unk) Qd), which was initiated on
Oct 11, 2012. Concurrently used drugs:
  • Ibuprofen Sandoz (Unk Ukn, Unk)
  • Zanidip (1 Df, (10 Mg) Qd)
  • Zoloft (sertraline Hydrochloride) (50 Mg, Qd)
  • Xanax (0.25 Mg, Qd)
  • Imovane (1 Df, Qd)
  • Levothyrox (50 Ug, Qd)
  • Crestor (5 Mg, Qd)
  • Inexium//esomeprazole Magnesium (20 Mg, Qd)
.After starting to take Cotareg the consumer reported adverse symptoms, such as: Hypotension, Renal Failure AcuteThese side effects may potentially be related to Cotareg. The patient was hospitalized.
Cotareg Side Effect Report#9644751
Cerebral Hypoperfusion, Confusional State, Hyponatraemia, Hypotension
This is a report of a 76-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: hypertension,constipation, who was treated with Cotareg (dosage: 1 Df (1 Posologic Unit) A Day, start time:
Oct 06, 2013), combined with:
  • Laevolac (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Cerebral Hypoperfusion, Confusional State, Hyponatraemia, Hypotension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in male patients, resulting in Cerebral Hypoperfusion side effect. The patient was hospitalized.
Cotareg Side Effect Report#9642930
Contusion, Femur Fracture, Syncope
This report suggests a potential Cotareg Contusion side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: hypertension and used Cotareg (dosage: 1 Df (1 Posologic Unit) Qd) starting
Mar 20, 2013. After starting Cotareg the patient began experiencing various side effects, including: Contusion, Femur Fracture, SyncopeAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cotareg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Contusion, may still occur.
Cotareg Side Effect Report#9555681
Hypoglycaemic Coma, Diarrhoea, Renal Failure Acute
This Hypoglycaemic Coma problem was reported by a health professional from FR. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,type 2 diabetes mellitus,sciatica. On
Jul 30, 2013 this consumer started treatment with Cotareg (dosage: 1 Df (160mg Vals, 12.5mg Hctz), Qd). The following drugs were being taken at the same time:
  • Amarel (1 Mg, Bid)
  • Profenid (100 Mg, Qd)
  • Miorel (4 Mg, Bid)
  • Klipal Codeine (1 Df (600mg Para/ 50mg Code), Qid)
  • Lipanthyl (145 Mg, Qd)
  • Loxen (20 Mg, Qd)
  • Daflon (diosmin/hesperidin) (500 Mg, Bid)
  • Topalgic (50 Mg, Bid)
When using Cotareg, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemic Coma, Diarrhoea, Renal Failure AcuteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemic Coma, may become evident only after a product is in use by the general population.
Cotareg Side Effect Report#9528163
Blood Pressure Systolic Increased, Weight Decreased, Blood Pressure Decreased, Abdominal Pain, Dizziness
This Blood Pressure Systolic Increased side effect was reported by a consumer or non-health professional from FR. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Cotareg (drug dosage: 1 Df (80 Mg Vals,12.5 Mg Hct), Every 2 Days), which was initiated on
Sep 22, 2013. Concurrently used drugs: NA..After starting to take Cotareg the consumer reported adverse symptoms, such as: Blood Pressure Systolic Increased, Weight Decreased, Blood Pressure Decreased, Abdominal Pain, DizzinessThese side effects may potentially be related to Cotareg.
Cotareg Side Effect Report#9506539
Confusional State, Hyponatraemia
This is a report of a 88-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: hypertension, who was treated with Cotareg (dosage: 1 Df, Daily, start time:
Jan 01, 2011), combined with:
  • Lasix (1 Df (25mg), Daily)
  • Plaquenil (Unk Ukn, Unk)
  • Deltacortene (Unk Ukn, Unk)
  • Cardirene (Unk Ukn, Unk)
  • Nexum (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Confusional State, Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in female patients, resulting in Confusional State side effect. The patient was hospitalized.
Cotareg Side Effect Report#9506517
Cholestasis, Hepatocellular Injury, Hepatotoxicity, Renal Failure Acute, Nephropathy Toxic, Haemolysis
This report suggests a potential Cotareg Cholestasis side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension and used Cotareg (dosage: 1 Df, Daily (160 Mg Vals, Unk Hctz)) starting NS. After starting Cotareg the patient began experiencing various side effects, including: Cholestasis, Hepatocellular Injury, Hepatotoxicity, Renal Failure Acute, Nephropathy Toxic, HaemolysisAdditional drugs used concurrently:
  • Xanax (1 Df, Tid)
  • Norset (15 Mg, Daily)
  • Mono-tildiem (1 Df, Daily)
  • Tahor (1 Df (40 Mg) Daily)
  • Lasilix (1 Df, Daily)
  • Hyperium (1 Df, Daily)
The patient was hospitalized. Although Cotareg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cholestasis, may still occur.
Cotareg Side Effect Report#9492533
Hyponatraemia
This Hyponatraemia problem was reported by a health professional from FR. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,condition aggravated,cranial nerve disorder,gastric disorder,hypercholesterolaemia,hypothyroidism. On
Jul 19, 2013 this consumer started treatment with Cotareg (dosage: 1 Df (160/12.5 Mg), Qd). The following drugs were being taken at the same time:
  • Voltarene Lp (75 Mg, Qd)
  • Voltarene Lp
  • Mopral (Unk Ukn, Unk)
  • Pravastatin Aaa (20 Mg, Qd)
  • Levothyrox (75 Ug, Qd)
  • Loxen (50 Mg, Qd)
  • Veratran (5 Mg, Qd)
  • Lamaline (2 Df, Tid)
When using Cotareg, the patient experienced the following unwanted symptoms/side effects: HyponatraemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hyponatraemia, may become evident only after a product is in use by the general population.
Cotareg Side Effect Report#9459667
Pustular Psoriasis
This Pustular Psoriasis side effect was reported by a health professional from FR. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension,prophylaxis.The patient was prescribed Cotareg (drug dosage: Unk Ukn, Unk), which was initiated on 201207. Concurrently used drugs:
  • Optiject (350 Mg D?iodine/ml)
.After starting to take Cotareg the consumer reported adverse symptoms, such as: Pustular PsoriasisThese side effects may potentially be related to Cotareg. The patient was hospitalized.
Cotareg Side Effect Report#9459448
Colitis Microscopic, Diarrhoea
This is a report of a 67-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Cotareg (dosage: Unk Ukn, Unk, start time: 2005), combined with:
  • Hyperium (1 Mg, Unk)
  • Metformin (Unk Ukn, Unk)
  • Seloken (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Colitis Microscopic, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in female patients, resulting in Colitis Microscopic side effect.
Cotareg Side Effect Report#9455385
Blood Pressure Inadequately Controlled, Vascular Occlusion, Ear Pain, Sleep Disorder
This report suggests a potential Cotareg Blood Pressure Inadequately Controlled side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from ZA was diagnosed with the following symptoms/conditions: hypertension and used Cotareg (dosage: 80 Mg, Daily) starting 201209. After starting Cotareg the patient began experiencing various side effects, including: Blood Pressure Inadequately Controlled, Vascular Occlusion, Ear Pain, Sleep DisorderAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cotareg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Inadequately Controlled, may still occur.
Cotareg Side Effect Report#9406820
Face Oedema, Eczema, Toxic Skin Eruption
This Face Oedema problem was reported by a health professional from FR. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Cotareg (dosage: NA). The following drugs were being taken at the same time:
  • Procoralan
  • Pravadual
  • Olmetec
  • Duoplavin (Unk)
When using Cotareg, the patient experienced the following unwanted symptoms/side effects: Face Oedema, Eczema, Toxic Skin EruptionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Face Oedema, may become evident only after a product is in use by the general population.
Cotareg Side Effect Report#9338616
Mucosal Inflammation, Neutropenia
This Mucosal Inflammation side effect was reported by a health professional from FR. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cotareg (drug dosage: 1 Df (vals 160mg, Hctz 25mg), Qd), which was initiated on
Mar 28, 2011. Concurrently used drugs:
  • Taxotere (Unk Ukn, Unk)
  • Herceptin (Unk Ukn, Unk)
  • Efferalgan (If Needed)
  • Lopressor (200 Mg, Qd)
  • Tahor (10 Mg, Qd)
  • Rilmenidine (1 Mg, Qd)
  • Stablon (12.5 Mg, Tid)
  • Seresta (0.5 Df (50 Mg) Qd)
.After starting to take Cotareg the consumer reported adverse symptoms, such as: Mucosal Inflammation, NeutropeniaThese side effects may potentially be related to Cotareg. The patient was hospitalized.
Cotareg Side Effect Report#9311812
Lichenoid Keratosis, Pigmentation Disorder, Acanthosis, Lymphocytic Infiltration, Ichthyosis, Toxic Skin Eruption
This is a report of a 65-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: hypertension, who was treated with Cotareg (dosage: 1 Df (160 Mg Vals And 12.5 Mg Hctz), Qd, start time: 2012), combined with:
  • Zofenopril (1 Df, Qd)
and developed a serious reaction and side effect(s): Lichenoid Keratosis, Pigmentation Disorder, Acanthosis, Lymphocytic Infiltration, Ichthyosis, Toxic Skin Eruption after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in male patients, resulting in Lichenoid Keratosis side effect.
Cotareg Side Effect Report#9297670
Weight Decreased, Hyperkalaemia, Renal Failure Acute, Vomiting, Diarrhoea, Body Temperature Decreased, Heart Rate Increased, Metabolic Acidosis, Blood Potassium Decreased
This report suggests a potential Cotareg Weight Decreased side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension,gout and used Cotareg (dosage: 1 Df (vals 80 Mg, Hctz 12.5 Mg) Qd) starting
Mar 25, 2013. After starting Cotareg the patient began experiencing various side effects, including: Weight Decreased, Hyperkalaemia, Renal Failure Acute, Vomiting, Diarrhoea, Body Temperature Decreased, Heart Rate Increased, Metabolic Acidosis, Blood Potassium DecreasedAdditional drugs used concurrently:
  • Colchicine Opocalium (1 Mg, Unk)
  • Nifluril (1 Df (250 Mg) Tid)
  • Metformine (3 G, Daily)
The patient was hospitalized. Although Cotareg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Weight Decreased, may still occur.
Cotareg Side Effect Report#9201630
Rash Maculo-papular, Pruritus
This Rash Maculo-papular problem was reported by a health professional from FR. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 21, 2013 this consumer started treatment with Cotareg (dosage: 1 Df (160 Mg Vals And 12.5 Mg Hydro), Qd). The following drugs were being taken at the same time:
  • Clarithromycin (250 Mg, Qd)
  • Fucidine (500 Mg, Tid)
When using Cotareg, the patient experienced the following unwanted symptoms/side effects: Rash Maculo-papular, PruritusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash Maculo-papular, may become evident only after a product is in use by the general population.
Cotareg Side Effect Report#9185189
Pyrexia, Myalgia, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased
This Pyrexia side effect was reported by a health professional from FR. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cotareg (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Metformin
  • Victoza
  • Levemir
.After starting to take Cotareg the consumer reported adverse symptoms, such as: Pyrexia, Myalgia, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase IncreasedThese side effects may potentially be related to Cotareg. The patient was hospitalized.
Cotareg Side Effect Report#9125135
Renal Failure Acute, Anuria, Hyperkalaemia
This is a report of a 88-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Cotareg (dosage: 1 Df (160 Mg Val/12.5 Mg Hct) Daily, start time: NS), combined with:
  • Furosemide (20 Mg, Daily)
  • Diltiazem (1 Df, Daily)
  • Eupressyl (1 Df, Bid)
  • Pravastatin Sodium (20 Mg, Unk)
  • Previscan (10 Mg, Daily)
  • Nitriderm (1 Df Daily)
  • Pantoprazole (20 Mg, Daily)
  • Paracetamol (1.5 G, Daily)
and developed a serious reaction and side effect(s): Renal Failure Acute, Anuria, Hyperkalaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in female patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Cotareg Side Effect Report#9122235
Burning Sensation, Oedema Peripheral, Pruritus, Pain In Extremity, Gait Disturbance, Neuropathy Peripheral
This report suggests a potential Cotareg Burning Sensation side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension and used Cotareg (dosage: 1 Df, (160 Mg Vals And 12.5 Mg Hctz),qd) starting 201209. After starting Cotareg the patient began experiencing various side effects, including: Burning Sensation, Oedema Peripheral, Pruritus, Pain In Extremity, Gait Disturbance, Neuropathy PeripheralAdditional drugs used concurrently: NA. Although Cotareg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Burning Sensation, may still occur.
Cotareg Side Effect Report#9115325
Arrhythmia, Hyponatraemia
This Arrhythmia problem was reported by a health professional from IT. A 92-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On
Jan 01, 2012 this consumer started treatment with Cotareg (dosage: 0.5 Df, Daily (320 Mg Vals, 12.5 Mg Hydr)). The following drugs were being taken at the same time:
  • Lasix (25 Mg, Daily)
  • Tamsulosin
  • Avodart (0.5 Mg, Unk)
  • Lanoxin (0.125 Mg, Unk)
  • Cardirene (160 Mg, Unk)
When using Cotareg, the patient experienced the following unwanted symptoms/side effects: Arrhythmia, HyponatraemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arrhythmia, may become evident only after a product is in use by the general population.
Cotareg Side Effect Report#9022261
Bradycardia, Lactic Acidosis, Cardiogenic Shock
This Bradycardia side effect was reported by a health professional from FR. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cotareg (drug dosage: 30 Df, Unk), which was initiated on
May 18, 2012. Concurrently used drugs:
  • Isoptine (45 Df, Unk)
  • Tahor (30 Df, Unk)
.After starting to take Cotareg the consumer reported adverse symptoms, such as: Bradycardia, Lactic Acidosis, Cardiogenic ShockThese side effects may potentially be related to Cotareg.
Cotareg Side Effect Report#8984950
Torsade De Pointes, Cardiac Arrest, Electrocardiogram Qt Prolonged, Coma, Hypokalaemia, Bradycardia, Decerebration, Hypokinesia, Troponin Increased
This is a report of a 45-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Cotareg (dosage: 1 Df (80 Mg Vals /12.5 Mg Hctz), Unk, start time:
Oct 12, 2012), combined with:
  • Haldol (5 Mg, Unk)
  • Dipiperon (40 Mg, Unk)
  • Cerazet
  • Prozac
  • Xanax
and developed a serious reaction and side effect(s): Torsade De Pointes, Cardiac Arrest, Electrocardiogram Qt Prolonged, Coma, Hypokalaemia, Bradycardia, Decerebration, Hypokinesia, Troponin Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cotareg treatment in female patients, resulting in Torsade De Pointes side effect.


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The appearance of Cotareg 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.


What are common Cotareg Side Effects for Women?

Women Side EffectsReports
Hyponatraemia 20
Dizziness 10
Hypokalaemia 10
Malaise 10
Renal Failure Acute 10
Blood Creatinine Increased 9
Diarrhoea 9
Fall 9
Confusional State 8
Dehydration 7

What are common Cotareg Side Effects for Men?

Men Side EffectsReports
Erythema 4
Fatigue 4
Headache 4
Hypotension 4
Malaise 4
Renal Failure 4
Renal Failure Acute 4
Dehydration 3
Dyspnoea 3
Face Oedema 3

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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.

    Cotareg 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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