Divalproex is an anti-epileptic agent sold in the U.S. under 4 brand and generic names, for bipolar disorder, epilepsy and absence epilepsy. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Depakote Cp (application NDA019794). Other divalproex products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Divalproex sodium delayed-release tablets are intended for oral administration. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed. Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose. Divalproex sodium delayed-release tablets are administered orally in divided doses. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed ( 2.1 , 2.2 ). Mania: Initial dose is 750 mg daily, increasing as rapidly as possible to achieve therapeutic response or desired plasma level (2.1). The maximum recommended dosage is 60 mg/kg/day ( 2.1 , 2.2 ). Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy ( 2.2 ). The maximum recommended dosage is 60 mg/kg/day ( 2.1 , 2.2). Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects (2.2). The maximum recommended dosage is 60 mg/kg/day ( 2.1…
The following serious adverse reactions are described below and elsewhere in the labeling: Hepatic Failure [see Warnings and Precautions (5.1) ] Birth Defects [see Warnings and Precautions (5.2) ] Decreased IQ and Neurodevelopmental Disorders Following in utero Exposure [see Warnings and Precautions (5.3) ] Pancreatitis [see Warnings and Precautions (5.5) ] Hyperammonemic Encephalopathy [see Warnings and Precautions ( 5.6 , 5.9 , 5.10 )] Suicidal Behavior and Ideation [see Warnings and Precautions (5.7) ] Bleeding and Other Hematopoietic Disorders [see Warnings and Precautions (5.8) ] Hypothermia [see Warnings and Precautions (5.11) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.12) ] Serious Dermatologic Reactions [ see Warnings and Precautions ( 5.13 )] Angioedema [see Warnings and Precautions ( 5.14 )] Somnolence in the Elderly [see Warnings and Precautions ( 5.16 )] 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. Most common adverse reactions (reported ≥15% for any indication) are abdominal pain, alopecia, asthenia, diarrhea, diplopia, dizziness, headache, infection,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $6 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| U;380 | 250 mg | pink | oval | — |
| U;381 | 500 mg | yellow | oval | — |
| R;534 | 500 mg | gray | oval | — |
| R;533 | 250 mg | white | round | — |
| I49 | 250 mg | white | oval | — |
| I50 | 500 mg | gray |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Divalproex sodium delayed-release tablets are contraindicated in patients: with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions ( 5.1 )]. known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precautions ( 5.1 )]. with known hypersensitivity to divalproex sodium, sodium valproate, or valproic acid. Reactions have included multiorgan hypersensitivity, serious dermatologic reactions, and angioedema [see Warnings and Precautions ( 5.12 , 5.13 , 5.14 )]. with known urea cycle disorders [see Warnings and Precautions ( 5.6 )]. being treated for prophylaxis of migraine headaches who are pregnant or in women of childbearing potential who are not using effective contraception [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 ) and Use in Specific Populations ( 8.1 )] . Hepatic disease or significant hepatic dysfunction ( 4 , 5.1 ) Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) ( 4 , 5.1 ) Suspected POLG-related disorder in children under two years of age ( 4 , 5.1 ) Known hypersensitivity to the divalproex sodium, sodium valproate, or valproic acid( 4 , 5.12 , 5.13 , 5.14 ) Urea cycle disorders ( 4 , 5.6 ) Prophylaxis of…
Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn (7.1) Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives, methotrexate: Monitoring of valproate concentrations is recommended (7.1) Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g., diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement (7.2) Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose (7.2) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium (7.2) Topiramate: Hyperammonemia and encephalopathy ( 5.10 , 7.3 ) Cannabidiol: ALT and/or AST elevation ( 7.4 ) 7.1 Effects of Co-Administered Drugs on Valproate Clearance Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases (such as ritonavir), may increase the clearance of valproate. For…
| 72/100 |
| Prescription |
| Tablet |
| Generic |
| $6 |
| View → |
| 3 | 70/100 | Prescription | Tablet | Generic | $6 | View → |
| 4 | 64/100 | Prescription | Capsule | Generic | $6 | View → |
| oval |
| — |
| THIS;END;UP;RDY;532 | 125 mg | blue, white | capsule | — |
|---|