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Diovan (Valsartan) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Hypertension

Diovan (valsartan) has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan was similar to placebo.

The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients. The most common reasons for discontinuation of therapy with Diovan were headache and dizziness.

The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Diovan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%).

Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and valsartan patients.

In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p <0.001).

Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with Diovan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).

Diovan has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions.

Other adverse reactions that occurred in controlled clinical trials of patients treated with Diovan (>0.2% of valsartan patients) are listed below. It cannot be determined whether these events were causally related to Diovan.

Body as a Whole :  Allergic reaction and asthenia

Cardiovascular: Palpitations

Dermatologic: Pruritus and rash

Digestive: Constipation, dry mouth, dyspepsia, and flatulence

Musculoskeletal: Back pain, muscle cramps, and myalgia

Neurologic and Psychiatric: Anxiety, insomnia, paresthesia, and somnolence

Respiratory: Dyspnea

Special Senses: Vertigo

Urogenital: Impotence

Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

Pediatric Hypertensi on

No relevant differences were identified between the adverse experience profile for pediatric patients aged 6-16 years and that previously reported for adult patients. Neurocognitive and developmental assessment of pediatric patients aged 6 to 16 years revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.

In the one study (n=90) of pediatric patients (1-5 years), two deaths and three cases of on-treatment transaminase elevations were seen in the one-year open-label extension phase. These 5 events occurred in a study population in which patients frequently had significant co-morbidities. A causal relationship to Diovan has not been established.

Heart Failure

The adverse experience profile of Diovan in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the Valsartan Heart Failure Trial, comparing valsartan in total daily doses up to 320 mg (n=2,506) to placebo (n=2,494), 10% of valsartan patients discontinued for adverse reactions vs. 7% of placebo patients.

The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients. All patients received standard drug therapy for heart failure, frequently as multiple medications, which could include diuretics, digitalis, beta-blockers, or ACE inhibitors.

Valsartan (n=3,282) Placebo (n=2,740)
Dizziness 17% 9%
Hypotension 7% 2%
Diarrhea 5% 4%
Arthralgia 3% 2%
Fatigue 3% 2%
Back Pain 3% 2%
Dizziness, postural 2% 1%
Hyperkalemia 2% 1%
Hypotension, postural 2% 1%

Other adverse reactions with an incidence greater than 1% and greater than placebo included headache NOS, nausea, renal impairment NOS, syncope, blurred vision, upper abdominal pain and vertigo. (NOS = not otherwise specified).

From the long-term data in the Valsartan Heart Failure Trial, there did not appear to be any significant adverse reactions not previously identified.

Post-Myocardial Infarction

The safety profile of Diovan was consistent with the pharmacology of the drug and the background diseases, cardiovascular risk factors, and clinical course of patients treated in the post-myocardial infarction setting. The table shows the percent of patients discontinued in the valsartan and captopril-treated groups in the Valsartan in Acute Myocardial Infarction Trial (VALIANT) with a rate of at least 0.5% in either of the treatment groups.

Valsartan (n=4,885) Captopril (n=4,879)
Discontinuation for adverse reaction 5.8% 7.7%
Adverse reactions
      Hypotension NOS 1.4% 0.8%
      Cough 0.6% 2.5%
      Blood creatinine increased 0.6% 0.4%
      Rash NOS 0.2% 0.6%

Post-Marketing Experience

The following additional adverse reactions have been reported in post-marketing experience:

Hypersensitivity: There are rare reports of angioedema;

Digestive: Elevated liver enzymes and very rare reports of hepatitis;

Renal: Impaired renal function;

Clinical Laboratory Tests: Hyperkalemia;

Dermatologic: Alopecia.

Blood and Lymphatic: There are very rare reports of thrombocytopenia.

Vascular: Vasculitis.

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.



REPORTS OF SUSPECTED DIOVAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Diovan. The information is not vetted and should not be considered as verified clinical evidence.

Possible Diovan side effects / adverse reactions in 60 year old male

Reported by a physician from Japan on 2011-07-15

Patient: 60 year old male weighing 89.0 kg (195.8 pounds)

Reactions: Back Pain, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Liver Disorder, Pruritus Generalised, Malaise, Dyspnoea Exertional, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Cold Sweat, Cough

Adverse event resulted in: hospitalization

Suspect drug(s):
Warfarin Sodium
    Dosage: 4 mg (1 mg,4 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-11
    End date: 2011-05-31

Mexitil
    Dosage: 50mg x 6t x 3 (50 mg),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-11
    End date: 2011-06-03

Amlodipine Besylate
    Dosage: 5 mg (5 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-11
    End date: 2011-06-03

Diovan
    Dosage: 160 mg (80 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-11
    End date: 2011-06-03

Bisoprolol Fumarate
    Dosage: 5 mg (2.5 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-27
    End date: 2011-06-03

Mecobalamine (Becobalamin)
    Dosage: 550ug x 3t x 3 (500 mcg),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-03
    End date: 2011-06-03

Epinastine Hydrochloride (Aleroff)
    Dosage: (20 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-14
    End date: 2011-06-03

Doxazosin Mesylate
    Dosage: 4 mg (2 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-15
    End date: 2011-06-03

Lansoprazole
    Dosage: 15 mg (15 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-11
    End date: 2011-06-03

Pirmenol Hydrochloride/hydrate (Pimenol)
    Dosage: 50mg x 2capsules x 2 (50 mg),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-11
    End date: 2011-06-03

Mosapride Citrate/hydrate (Gasmotin)
    Dosage: 5mg x 3t x 3 (5 mg),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-02
    End date: 2011-06-03

Magnesium Oxide (Magmitt)
    Dosage: 250mg x 3t x 3 (250 mg),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-04
    End date: 2011-05-31

Sairei-TO
    Dosage: 8.1mg x 2t x 2 (8.1 mg),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-05
    End date: 2011-05-30



Possible Diovan side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from Brazil on 2011-10-03

Patient: 45 year old female

Reactions: Dizziness, Blood Pressure Decreased

Suspect drug(s):
Diovan
    Dosage: 160 mg, unk
    Indication: Blood Pressure Increased

Galvus MET
    Dosage: 1 df, (1000 mg metf and 50mg vild)
    Indication: Blood Glucose Increased



Possible Diovan side effects / adverse reactions in 59 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-03

Patient: 59 year old male

Reactions: Chromosome Analysis Abnormal, Chronic Myeloid Leukaemia

Suspect drug(s):
Diovan

Other drugs received by patient: Multi-Vitamins; Vitamin D; Simvastatin



See index of all Diovan side effect reports >>

Drug label data at the top of this Page last updated: 2012-02-28

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