This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Diovan as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Diovan as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension , to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 ) Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Diovan ® is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan. Control of high blood pressure ...
Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with Diovan in patients with diabetes [see Drug Interactions (7.3)] . Known hypersensitivity to any component. Do not coadminister aliskiren with Diovan in patients with diabetes ( 4 )
Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Diovan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Diovan as soon as possible [see Use in Specific Populations (8.1)] . 5.2 Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with Diovan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of Diovan, or the treatment should start under close medical supervision. Patients with heart failure or post-myocardi...
Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 has been evaluated for safety in more than 4000 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 adv...
Source: FDA SPL label for Diovan (Novartis Pharmaceuticals Corporation), effective 20260811. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 7,653 | 5,850 | 4,947 | 4,395 | 3,911 | 4,222 | 4,192 | 2,030 |
2,164 reports blaming this drug for every million Medicare prescriptions filled, which is 0.8× the typical drug on this site. (10,208 reports in 2024–2026, against 4,717,517 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 08/2026 | Class II | Novartis Pharmaceuticals Corporation | Failed Dissolution Specifications |
| 03/2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| 12/2018 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. |
| 12/2018 | Class II | Aurobindo Pharma USA Inc. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| 12/2018 | Class II | Aurobindo Pharma USA Inc. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| 12/2018 | Class II | Aurobindo Pharma USA Inc. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| 12/2018 | Class II | Aurobindo Pharma USA Inc. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| 08/2018 | Class III | Jubilant Cadista Pharmaceuticals, Inc. | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. |
| 08/2018 | Class III | Jubilant Cadista Pharmaceuticals, Inc. | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. |
| 08/2018 | Class III | Jubilant Cadista Pharmaceuticals, Inc. | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. |
| 08/2018 | Class II | Hetero Labs Limited Unit V | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
| 08/2018 | Class II | Hetero Labs Limited Unit V | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $74 in payments to US physicians and hospitals tied to this drug across 4 transactions (valsartan $74).
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Valsartan | 4,691,604 | $27 |
| Diovan | 25,913 | $800 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.