Top 300 Black Box warning

Tretinoin

"[all systemic] Severe ADR with APL, Differentiation syndrome (APL patients), Leukocytosis, Birth defects"

Timolol

[systemic] IHD following abrupt discontinuation

Baclofen

Abrupt Withdrawal

Dexmethylphenidate

Abuse and dependence

Lisdexamfetamine

Abuse and dependence

Methylphenidate

Abuse and dependence

Dextroamphetamine Sulfate

Abuse potential, cardiovascular events

Dextroamphetamine & Amphetamimine Mixed Salts

Abuse potential, cardiovascular events

Acetaminophen/Hydrocodone

Addiction, Abuse, Misuse

Oxycodone

Addiction, Abuse, Misuse, Life threatening respiratory depression, Neonatal Opioid withdrawal, CYP450 3A4 Interaction

Buprenorphine

Addiction, abuse, misuse, Life-threatening Respiratory Depression, Neonatal Opioid Withdrawal Syndrome, Risks from concomitant use with benzodiazepines or other CNS depressants

Methotrexate

Adverse reactions, hypersensitivity, pregnancy

Ticagrelor

"Bleeding, Use with >100 mg aspirin"

Warfarin

Bleeding risk

Metronidazole

Carcinogenic

Medroxyprogesterone

Cardiovascular disorders, breast cancer, dementia, long-term use, loss of bone mineral density

Progesterone

Cardiovascular disorders, probable dementia, breast cancer

Phenytoin

Cardiovascular risk associated with rapid infusion

Nabumetone

Cardiovascular Risk, GI risk

Ketorolac

Cardiovascular thrombotic events, GI risk

Atenolol

Cessation of Therapy

Desogestrel/Ethinyl Estradiol

Cigarette smoke and serious cardiovascular events

Drospirenone/Ethinyl Estradiol

Cigarette Smoke and Serious Cardiovascular Events

Ethinyl Estradiol/Etonogestrel

Cigarette Smoke and Serious cardiovascular events

Ethinyl Estradiol/Norgestimate

Cigarette smoke and serious cardiovascular events

Ethinyl Estradiol/Norgestrel

Cigarette smoke and serious cardiovascular events

Ethinyl Estradiol/Norethindrone

Cigarette smoke and serious cardiovascular events, endometrial cancer, breast cancer, dementia

Ethinyl Estradiol/Levonogestrel

Cigarette Smoke and serious cardiovascular events, Obesity and venous thromboembolism risk

Eszopiclone

Complex Sleep Behaviors

Zolpidem Tartrate

Complex sleep behaviors

Temazepam

"Concomitant use with opioids, Abuse, misuse, addiction, Dependence and withdrawal"

Pioglitiazone

Congestive heart failure

Clopidogrel

"Diminished antiplatelet effect in patients with 2 loss of function alleles of the CYP2C19 gene

Estradiol

Endometrial Cancer, Cardiovascular disease, breast cancer, dementia

Estrogens (Conjugated)

Endometrial Cancer, Cardiovascular disease, breast cancer, dementia

Clonidine

Epidural Use

Amlodipine/Benazepril

Fetal Toxicity

Benazepril

Fetal Toxicity

Enalapril Maleate

Fetal Toxicity

Hydrochlorothiazide/Lisinopril

Fetal Toxicity

Hydrochlorothiazide/Losartan

Fetal Toxicity

Hydrochlorothiazide/Valsartan

Fetal Toxicity

Irbesartan

Fetal Toxicity

Lisinopril

Fetal Toxicity

Losartan

Fetal Toxicity

Olmesartan

Fetal toxicity

Ramipril

Fetal toxicity

Telmisartan

Fetal toxicity

Valsartan

Fetal toxicity

Bumetanide

Fluid/Electrolyte Loss

Furosemide

Fluid/Electrolyte Loss

Acetaminophen/Codeine

Hepatic Toxicity, Addiction, Abuse, Misuse

Acetaminophen

Hepatotoxicity

Acetaminophen/Butalbital/Caffeine

Hepatotoxicity

Divalproex

Hepatoxicity, Patients with mitochondrial disease, Fetal risk, Pancreatitis

Cyclosporine

Hypertension/nephrotoxicity, psoriasis

Hydrochlorothiazide/Triamterene

Hypokalemia

Testosterone

"Increased BP, Virilization with 2ndary exposure in children, Pulmonary oil microembolism"

Risperidone

Increased mortality in elderly dementia patients

Quetiapine

"Increased mortality in elderly dementia patients, Suicidal thoughts and behavior"

Aripiprazole

"Increased mortality in elderly patients with dementia related psychosis, Suicidality and antidepressant drugs"

Olanzapine

Increased mortality in elderly patients with dementia related psychosis, post injection delirium/sedation syndrome

Lurasidone

Increased mortality in elderly patients with dementia related psychosis, suicidal thoughts and behaviors

Metoprolol

Ischemic Heart Disease

Metformin

Lactic Acidosis

Metformin/Sitagliptin

Lactic Acidosis

Amiodarone

Life Threatening Arrhythmias, Pulmonary Toxicity, Hepatotoxicity, Worsened Arrhythmia

Sotalol Hydrochloride

Life-threatening proarrhythmia

Fentanyl

Life-threatening respiratory depression, addiction, abuse, and misuse, neonatal opioid, neonatal opioid withdrawal syndrome, risk from concomitant use with benzodiazepines or other CNS depressants

Tramadol

"Medication errors, Addiction, abuse, misuse, Opioid analgesic REMS, Respiratory depression, Accidental ingestion, Ultra-rapid metabolism in children, Neonatal withdrawal syndrome. CYP450 interaction. Concomitant use with benzodiazepines or CNS depressants"

Lithium

Monitoring (Lithium Toxicity)

Flecainide Acetate

Mortalityl, Ventricular proarrhythmic effects in patients with atrial fibrillation/flutter

Cetirizine

OTC

Emtricitabine

Posttreatment Acute Exacerbation of Hepatitis B

Isotretinoin

Pregnancy, Special Prescribing Requirements

Rivaroxaban

"Premature discontinuation (increase thrombotic events), Spinal/epidural hematomas"

Promethazine Hydrochloride

Respiratory Depression (Pediatrics), Severe Tissue Injury

Alprazolam

Risk from concomitant use with opioids, Abuse, Misuse, Addiction, Dependence and Withdrawal Reactions

Clonazepam

Risk from concomitant use with opioids, Abuse, Misuse, Addiction, Dependence and Withdrawal Reactions

Diazepam

Risk from concomitant use with opioids, Abuse, Misuse, Addiction, Dependence and Withdrawal Reactions

Linaclotide

Risk of serious dehydration in pediatric patients younger than 2 years

Dulaglutide

Risk of thyroid C cell tumors

Exenatide

Risk of thyroid C-cell tumors

Lorazepam

Risks from concomitant use with opioids, abuse, misuse, addiction, dependence and withdrawal reactions

Morphine

Risks with neuroaxial administration, addiction, abuse, misuse, life threatening respiratory depression, neonatal opioid withdrawal syndrome

Ciprofloxacin

Serious adverse reactions, exacerbation of myasthenia gravis

Levofloxacin

Serious adverse reactions, exacerbation of myasthenia gravis

Celecoxib

Serious Cardiovascular Risk, Serious Gastrointestinal Risk

Ibuprofen

Serious Cardiovascular Thrombotic events, serious gastrointestinal bleeding, ulcerations, and perforation

Diclofenac

Serious cardiovascular thrombotic events, Serious GI bleeding, ulceration, and perforation

Naproxen

Serious cardiovascular thrombotic events, serious GI bleeding, ulceration, and perforation

Meloxicam

Serious cardiovascular thrombotic events, serious GI bleeding, ulcerations, and perforation

Etanercept

Serious Infections, Malignancies

Mycophenolate Mofetil

Serious infections, malignancies, embryo fetal toxicity

Montelukast

Serious neuropsychiatric events

Lamotrigine

Serious skin rashes

Apixaban

Spinal/Epidural Hematoma, Discontinuation

Atomoxetine

Suicidal ideation in children and adolescents

Desvenlafaxine

Suicidal thoughts and Behavior

Duloxetine

Suicidal thoughts and behavior