Common Exforge Side Effects


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

Blood Pressure Increased (128)
Hypertension (121)
Oedema Peripheral (105)
Death (105)
Dizziness (87)
Fall (81)
Dyspnoea (68)
Malaise (62)
Headache (61)
Blood Pressure Inadequately Controlled (45)
Blood Pressure Decreased (44)
Nausea (43)
Hypotension (43)
Cerebrovascular Accident (42)
Myocardial Infarction (41)
Fatigue (41)
Infarction (40)
Pain In Extremity (40)
Diabetes Mellitus (39)
Cough (37)

➢ 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.

Exforge Side Effects Reported to FDA



Exforge Side Effect Report#9986881
Infarction, Inflammation, Cardiac Disorder
This is a report of a 65-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: hypertension, who was treated with Exforge (dosage: 1 Df(160/10mg), Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Infarction, Inflammation, Cardiac Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge treatment in male patients, resulting in Infarction side effect.
Exforge Side Effect Report#9986764
Heart Rate Decreased, Diabetes Mellitus Inadequate Control, Blood Pressure Increased
This report suggests a potential Exforge Hct Heart Rate Decreased side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from MX was diagnosed with the following symptoms/conditions: hypertension and used Exforge Hct (dosage: 1 Tablet (160/5/12.5 Mg) Daily) starting
Feb 28, 2014. After starting Exforge Hct the patient began experiencing various side effects, including: Heart Rate Decreased, Diabetes Mellitus Inadequate Control, Blood Pressure IncreasedAdditional drugs used concurrently:
  • Co-diovan (160/12.5 Mg, Unk)
The patient was hospitalized. Although Exforge Hct demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Heart Rate Decreased, may still occur.
Exforge Side Effect Report#9934846
Spinal Cord Paralysis, Fall, Movement Disorder, Pulmonary Infarction, Pallor, Aggression, Overweight
This Spinal Cord Paralysis problem was reported by a consumer or non-health professional from MX. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On NS this consumer started treatment with Exforge Hct (dosage: 1 Df (160/5/12.5 Mg), Daily). The following drugs were being taken at the same time: NA. When using Exforge Hct, the patient experienced the following unwanted symptoms/side effects: Spinal Cord Paralysis, Fall, Movement Disorder, Pulmonary Infarction, Pallor, Aggression, OverweightThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Spinal Cord Paralysis, may become evident only after a product is in use by the general population.
Exforge Side Effect Report#9930993
Musculoskeletal Stiffness, Movement Disorder, Nervousness, Fatigue, Headache, Syncope, Myalgia, Oedema Peripheral, Vertigo
This Musculoskeletal Stiffness side effect was reported by a consumer or non-health professional from AU. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension,atrial fibrillation.The patient was prescribed Exforge (drug dosage: 1 Df (160/5 Mg), Unk), which was initiated on
Jan 03, 2014. Concurrently used drugs:
  • Warfarin Sodium (5 Mg, Unk)
.After starting to take Exforge the consumer reported adverse symptoms, such as: Musculoskeletal Stiffness, Movement Disorder, Nervousness, Fatigue, Headache, Syncope, Myalgia, Oedema Peripheral, VertigoThese side effects may potentially be related to Exforge.
Exforge Side Effect Report#9927035
Diabetes Mellitus, Cardiomegaly, Blood Triglycerides Increased, Nervousness, Hypotension
This is a report of a 56-year-old female patient (weight: NA) from MX, suffering from the following health symptoms/conditions: hypertension, who was treated with Exforge (dosage: 1 Df (160/10 Mg), Daily, start time: 201302), combined with: NA. and developed a serious reaction and side effect(s): Diabetes Mellitus, Cardiomegaly, Blood Triglycerides Increased, Nervousness, Hypotension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge treatment in female patients, resulting in Diabetes Mellitus side effect.
Exforge Side Effect Report#9911458
Hypertension, Chest Pain
This report suggests a potential Exforge Hct Hypertension side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Exforge Hct (dosage: 2 Df (160/10/25mg), Qd) starting NS. After starting Exforge Hct the patient began experiencing various side effects, including: Hypertension, Chest PainAdditional drugs used concurrently:
  • Metformin Hydrochloride Er Tablets (Unk Ukn, Unk)
  • Nitroglycerine (Unk Ukn, Unk)
  • Clonidine (Unk Ukn, Unk)
  • Glipizide (Unk Ukn, Unk)
  • Levemir (Unk Ukn, Unk)
The patient was hospitalized. Although Exforge Hct demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypertension, may still occur.
Exforge Side Effect Report#9903112
Cardiovascular Insufficiency
This Cardiovascular Insufficiency problem was reported by a consumer or non-health professional from MX. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On NS this consumer started treatment with Exforge (dosage: Unk). The following drugs were being taken at the same time: NA. When using Exforge, the patient experienced the following unwanted symptoms/side effects: Cardiovascular InsufficiencyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiovascular Insufficiency, may become evident only after a product is in use by the general population.
Exforge Side Effect Report#9901704
Deafness
This Deafness side effect was reported by a consumer or non-health professional from MX. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Exforge (drug dosage: 1 Df(160/10mg), Daily), which was initiated on
Feb 12, 2014. Concurrently used drugs: NA..After starting to take Exforge the consumer reported adverse symptoms, such as: DeafnessThese side effects may potentially be related to Exforge.
Exforge Side Effect Report#9894321
Diabetes Mellitus
This is a report of a 78-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: hypertension, who was treated with Exforge (dosage: 1 Df (160/5mg) Daily, start time: 201204), combined with: NA. and developed a serious reaction and side effect(s): Diabetes Mellitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge treatment in female patients, resulting in Death side effect.
Exforge Side Effect Report#9891578
Dermatitis Bullous, Acne, Pruritus
This report suggests a potential Exforge Dermatitis Bullous side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension and used Exforge (dosage: 1 Df (160mg Vals, 10 Mg Amlo), Unk) starting 201302. After starting Exforge the patient began experiencing various side effects, including: Dermatitis Bullous, Acne, PruritusAdditional drugs used concurrently:
  • Furosemide (Unk Ukn, Unk)
  • Allopurinol (Unk)
  • Allopurinol (Unk)
Although Exforge demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dermatitis Bullous, may still occur.
Exforge Side Effect Report#9886694
Myelodysplastic Syndrome
This Myelodysplastic Syndrome problem was reported by a consumer or non-health professional from Country Not Specified. A 86-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On 201201 this consumer started treatment with Exforge (dosage: 1 Df (320/5mg) Daily). The following drugs were being taken at the same time:
  • Hydrochlorothiazide (Unk Ukn, Unk)
When using Exforge, the patient experienced the following unwanted symptoms/side effects: Myelodysplastic SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myelodysplastic Syndrome, may become evident only after a product is in use by the general population.
Exforge Side Effect Report#9886693
Coeliac Disease
This Coeliac Disease side effect was reported by a consumer or non-health professional from Country Not Specified. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Exforge (drug dosage: 1 Df (160/5mg), Daily), which was initiated on NS. Concurrently used drugs: NA..After starting to take Exforge the consumer reported adverse symptoms, such as: Coeliac DiseaseThese side effects may potentially be related to Exforge.
Exforge Side Effect Report#9870905
Cardiac Arrest
This is a report of a 60-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: hypertension, who was treated with Exforge (dosage: 160/5mg, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Cardiac Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge treatment in female patients, resulting in Cardiac Arrest side effect.
Exforge Side Effect Report#9860553
Oedema Peripheral, Pain In Extremity, Cough
This report suggests a potential Exforge Oedema Peripheral 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: hypertension and used Exforge (dosage: 1 Ukn (320/10ukn), Daily) starting 200711. After starting Exforge the patient began experiencing various side effects, including: Oedema Peripheral, Pain In Extremity, CoughAdditional drugs used concurrently:
  • Benazepril (Unk Ukn, Unk)
  • Diovan (Unk Ukn, Unk)
Although Exforge demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oedema Peripheral, may still occur.
Exforge Side Effect Report#9857517
Silent Myocardial Infarction, Troponin Increased, Fatigue, Asthenia, Dizziness, Nausea
This Silent Myocardial Infarction problem was reported by a consumer or non-health professional from DE. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201210 this consumer started treatment with Exforge (dosage: 1 Df (80 Mg Vals/ 5 Mg Amlo), Qd). The following drugs were being taken at the same time: NA. When using Exforge, the patient experienced the following unwanted symptoms/side effects: Silent Myocardial Infarction, Troponin Increased, Fatigue, Asthenia, Dizziness, NauseaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Silent Myocardial Infarction, may become evident only after a product is in use by the general population.
Exforge Side Effect Report#9857513
Hypoglycaemia, Chondropathy, Renal Impairment, Feeling Abnormal
This Hypoglycaemia side effect was reported by a consumer or non-health professional from MX. A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Exforge (drug dosage: 1 Tablet (320/10 Mg) Daily), which was initiated on 201312. Concurrently used drugs: NA..After starting to take Exforge the consumer reported adverse symptoms, such as: Hypoglycaemia, Chondropathy, Renal Impairment, Feeling AbnormalThese side effects may potentially be related to Exforge.
Exforge Side Effect Report#9856189
Prostate Cancer, Hypovolaemic Shock, Gastrointestinal Haemorrhage, Multi-organ Failure, Urinary Tract Infection
This is a report of a 93-year-old male patient (weight: NA) from MX, suffering from the following health symptoms/conditions: hypertension, who was treated with Exforge Hct (dosage: 1 Tablet (160/5/12.5 Mg) Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Prostate Cancer, Hypovolaemic Shock, Gastrointestinal Haemorrhage, Multi-organ Failure, Urinary Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge Hct treatment in male patients, resulting in Prostate Cancer side effect.
Exforge Side Effect Report#9855921
Diabetes Mellitus, Fatigue
This report suggests a potential Exforge Diabetes Mellitus side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: NA and used Exforge (dosage: 1 Df (160 Mg Vals/ 5 Mg Amlo), Daily) starting 2011. After starting Exforge the patient began experiencing various side effects, including: Diabetes Mellitus, FatigueAdditional drugs used concurrently:
  • Norvasc
  • Tritace
Although Exforge demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diabetes Mellitus, may still occur.
Exforge Side Effect Report#9854979
Blood Pressure Increased, Nervousness, Decreased Appetite, Headache, Vomiting, Insomnia
This Blood Pressure Increased problem was reported by a consumer or non-health professional from US. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 20, 2013 this consumer started treatment with Exforge (dosage: 1 Df (320/10 Mg), Qd). The following drugs were being taken at the same time: NA. When using Exforge, the patient experienced the following unwanted symptoms/side effects: Blood Pressure Increased, Nervousness, Decreased Appetite, Headache, Vomiting, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Pressure Increased, may become evident only after a product is in use by the general population.
Exforge Side Effect Report#9850799
Insomnia, Oedema Peripheral, Arthralgia, Pain In Extremity
This Insomnia side effect was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Exforge Hct (drug dosage: 1 Df (valsa320 Mg/ Amlo 10 Mg Hct 25 Mg) Qd, Oral), which was initiated on NS. Concurrently used drugs:
  • Bystolic
  • Lisinopril (lisinopril)
  • Pravastatin (pravastatin)
  • Doxazosin (doxazosin)
  • Hydrocodone (hydrocodone)
.After starting to take Exforge Hct the consumer reported adverse symptoms, such as: Insomnia, Oedema Peripheral, Arthralgia, Pain In ExtremityThese side effects may potentially be related to Exforge Hct.
Exforge Side Effect Report#9850793
Blood Pressure Increased
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Exforge Hct (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Blood Pressure Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge Hct treatment in male patients, resulting in Blood Pressure Increased side effect.
Exforge Side Effect Report#9850790
Blood Pressure Increased
This report suggests a potential Exforge Hct Blood Pressure Increased side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Exforge Hct (dosage: NA) starting NS. After starting Exforge Hct the patient began experiencing various side effects, including: Blood Pressure IncreasedAdditional drugs used concurrently: NA. Although Exforge Hct demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Increased, may still occur.
Exforge Side Effect Report#9850098
Diabetes Mellitus
This Diabetes Mellitus problem was reported by a consumer or non-health professional from MX. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,heart rate abnormal. On 201101 this consumer started treatment with Exforge (dosage: 1 Df (160/5 Mg), Daily). The following drugs were being taken at the same time:
  • Tenormin (50 Mg, Daily)
When using Exforge, the patient experienced the following unwanted symptoms/side effects: Diabetes MellitusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diabetes Mellitus, may become evident only after a product is in use by the general population.
Exforge Side Effect Report#9846233
Pain, Vomiting, Headache
This Pain side effect was reported by a physician from AE. A 36-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Exforge Hct (drug dosage: 1 Df (160 Mg Vals/5 Mg Amlo/12.5 Mg Hydro), Daily), which was initiated on
Nov 07, 2013. Concurrently used drugs:
  • Preterax (2.5 Mg, Unk)
.After starting to take Exforge Hct the consumer reported adverse symptoms, such as: Pain, Vomiting, HeadacheThese side effects may potentially be related to Exforge Hct.
Exforge Side Effect Report#9839851
Gallbladder Disorder, Burning Sensation, Oedema Peripheral, Chest Pain, Pain
This is a report of a 85-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: hypertension, who was treated with Exforge Hct (dosage: 1 Df, (vals 320 Mg, Amlo 10 Mg , Hydr 25 Mg) Daily, start time:
Jan 15, 2014), combined with:
  • Co-diovan (1 Df, (vals 80mg, Hydr 12.5 Mg) 1 Tablet In Morning And 1 Tablet At Night, Daily)
  • Amicil//amikacin Sulfate (1 Ukn, Daily)
  • Aspirin Protect (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Gallbladder Disorder, Burning Sensation, Oedema Peripheral, Chest Pain, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Exforge Hct treatment in female patients, resulting in Gallbladder Disorder side effect.


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The appearance of Exforge 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 Exforge Side Effects for Women?

Women Side Effects Reports
Hypertension 90
Blood Pressure Increased 88
Oedema Peripheral 73
Death 60
Fall 60
Dizziness 59
Dyspnoea 47
Headache 44
Malaise 43
Blood Pressure Decreased 31

What are common Exforge Side Effects for Men?

Men Side Effects Reports
Death 45
Blood Pressure Increased 40
Oedema Peripheral 32
Hypertension 31
Dizziness 27
Cerebrovascular Accident 22
Renal Failure 22
Dyspnoea 21
Fall 21
Infarction 20

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.

    Exforge 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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    Exforge Safety Alerts, Active Ingredients, Usage Information

    NDC 0078-0488
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Exforge
    Name amlodipine besylate and valsartan
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 20070620
    Labeler Novartis Pharmaceuticals Corporation
    Active Ingredient(s) AMLODIPINE BESYLATE; VALSARTAN
    Strength(s) 5; 160
    Unit(s) mg/1; mg/1
    Pharma Class Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Ch

    Exforge Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1550

    Exforge safety alerts: No

    Reported deaths: 287

    Reported hospitalizations: 483

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