Acetaminophen and Butalbital

Acetaminophen and Butalbital Brand Names

Allzital | Axocet | Bucet | Bupap | Cephadyn | Dolgic | Marten | ORBIVAN CF | Phrenilin | Phrenilin Forte | Promacet | Repan CF | Sedapap | Tencon

What is Acetaminophen and Butalbital

Acetaminophen, a non-salicylate analgesic, and butalbital, a barbiturate, are used together in oral products to treat tension headaches in adult and pediatric patients 12 years of age and older, especially when antianxiety or relaxant effects are needed.

Treatment of multiple recurrent headaches with acetaminophen; butalbital has not been well studied and extended use of these products is not recommended.

No data from randomized, placebo-controlled trials to prove or refute the efficacy of acetaminophen; butalbital for the acute treatment of migraines are available.

According to published guidelines for the acute management of migraine, the use of butalbital-containing analgesics should be limited and carefully monitored due to concerns of overuse, medication-overuse headache, abuse, and withdrawal.

All acetaminophen-containing products carry a boxed warning in their prescribing information regarding the risk for hepatotoxicity, particularly with oral doses exceeding 4 grams/day.

Indications & Dosage

• headache

General dosing information:

• Maximum daily dosage limits for acetaminophen are based on all routes of administration (e.g., intravenous, oral, rectal) and all products containing acetaminophen, including both single-entity and combination products. Exceeding maximum daily dosage limits can result in hepatic injury, hepatic failure, and death. In an attempt to reduce the risk of hepatotoxicity, the FDA has recommended limiting the amount of acetaminophen in prescription combination products to 325 mg per dosage unit.
• Extended use is inadvisable due to the habit-forming and abusable nature of butalbital. The safety and efficacy of acetaminophen; butalbital for multiple, recurrent headaches is not established.

Side Effects

1. abdominal pain
2. acneiform rash
3. acute generalized exanthematous pustulosis (AGEP)
4. agitation
5. agranulocytosis
6. anaphylactoid reactions
7. angioedema
8. anorexia
9. coma
10. confusion
11. constipation
12. contact dermatitis
13. diuresis
14. dizziness
15. drowsiness
16. dyspepsia
17. dysphagia
18. dyspnea
19. elevated hepatic enzymes
20. emotional lability
21. erythema
22. erythema multiforme
23. euphoria
24. exfoliative dermatitis
25. fatigue
26. fever
27. flatulence
28. headache
29. hemolysis
30. hemolytic anemia
31. hepatic encephalopathy
32. hepatic failure
33. hepatic necrosis
34. hepatotoxicity
35. hot flashes
36. hyperhidrosis
37. hypoprothrombinemia
38. hypotension
39. impaired cognition
40. increased urinary frequency
41. interstitial nephritis
42. jaundice
43. lethargy
44. maculopapular rash
45. malaise
46. musculoskeletal pain
47. nasal congestion
48. nausea
49. neutropenia
50. otalgia
51. pancytopenia
52. paresthesias
53. photosensitivity
54. physiological dependence
55. pruritus
56. psychological dependence
57. ptosis
58. purpura
59. rash
60. renal failure (unspecified)
61. renal papillary necrosis
62. renal tubular necrosis
63. respiratory depression
64. seizures
65. sinus tachycardia
66. Stevens-Johnson syndrome
67. syncope
68. thrombocytopenia
69. thrombocytosis
70. tinnitus
71. tolerance
72. toxic epidermal necrolysis
73. urticaria
74. vertigo
75. vomiting
76. withdrawal
77. xerostomia

Monitoring Parameters

• LFTs
• serum creatinine/BUN

Contraindications

• abrupt discontinuation
• acetaminophen hypersensitivity
• acute abdomen
• agranulocytosis
• alcoholism
• barbiturate hypersensitivity
• breast-feeding
• carbamazepine hypersensitivity
• children
• chronic obstructive pulmonary disease (COPD)
• CNS depression
• coadministration with other CNS depressants
• depression
• driving or operating machinery
• ethanol ingestion
• ethanol intoxication
• G6PD deficiency
• geriatric
• head trauma
• hepatic disease
• hepatitis
• hepatotoxicity
• hydantoin hypersensitivity
• hypovolemia
• infants
• malnutrition
• neonates
• porphyria
• potential for overdose or poisoning
• pregnancy
• pulmonary disease
• renal failure
• renal impairment
• respiratory depression
• sleep apnea
• substance abuse
• suicidal ideation

Interactions

• Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
• Abemaciclib
• Acetaminophen; Aspirin, ASA; Caffeine
• Acetaminophen; Butalbital; Caffeine
• Acetaminophen; Butalbital; Caffeine; Codeine
• Acetaminophen; Caffeine
• Acetaminophen; Caffeine; Dihydrocodeine
• Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
• Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
• Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
• Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
• Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
• Acetaminophen; Codeine
• Acetaminophen; Dextromethorphan; Doxylamine
• Acetaminophen; Dichloralphenazone; Isometheptene
• Acetaminophen; Diphenhydramine
• Acetaminophen; Hydrocodone
• Acetaminophen; Oxycodone
• Acetaminophen; Pentazocine
• Acetaminophen; Tramadol
• Acetazolamide
• Acrivastine; Pseudoephedrine
• Aldesleukin, IL-2
• Alfentanil
• Aliskiren; Amlodipine
• Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
• Aliskiren; Hydrochlorothiazide, HCTZ
• Alprazolam
• Altretamine
• Amiloride; Hydrochlorothiazide, HCTZ
• Aminosalicylate sodium, Aminosalicylic acid
• Amitriptyline; Chlordiazepoxide
• Amlodipine
• Amlodipine; Atorvastatin
• Amlodipine; Benazepril
• Amlodipine; Celecoxib
• Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
• Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
• Amlodipine; Olmesartan
• Amlodipine; Telmisartan
• Amlodipine; Valsartan
• Amobarbital
• Amoxapine
• Amoxicillin; Clarithromycin; Lansoprazole
• Amoxicillin; Clarithromycin; Omeprazole
• Amprenavir
• Anagrelide
• Antacids
• Apomorphine
• Apraclonidine
• Apremilast
• Aprepitant, Fosaprepitant
• Aripiprazole
• Armodafinil
• Artemether; Lumefantrine
• Articaine; Epinephrine
• Asenapine
• Aspirin, ASA
• Aspirin, ASA; Butalbital; Caffeine
• Aspirin, ASA; Butalbital; Caffeine; Codeine
• Aspirin, ASA; Caffeine; Dihydrocodeine
• Aspirin, ASA; Caffeine; Orphenadrine
• Aspirin, ASA; Carisoprodol
• Aspirin, ASA; Carisoprodol; Codeine
• Aspirin, ASA; Citric Acid; Sodium Bicarbonate
• Aspirin, ASA; Dipyridamole
• Aspirin, ASA; Omeprazole
• Aspirin, ASA; Oxycodone
• Aspirin, ASA; Pravastatin
• Atazanavir
• Atazanavir; Cobicistat
• Atenolol; Chlorthalidone
• Atorvastatin
• Atorvastatin; Ezetimibe
• Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
• Atropine; Difenoxin
• Atropine; Diphenoxylate
• Atropine; Hyoscyamine; Phenobarbital; Scopolamine
• Avanafil
• Avapritinib
• Avatrombopag
• Axitinib
• Azelastine
• Azelastine; Fluticasone
• Azilsartan; Chlorthalidone
• Barbiturates
• Bedaquiline
• Belladonna Alkaloids; Ergotamine; Phenobarbital
• Belladonna; Opium
• Benazepril; Hydrochlorothiazide, HCTZ
• Bendamustine
• Bendroflumethiazide; Nadolol
• Benzhydrocodone; Acetaminophen
• Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
• Benztropine
• Bicalutamide
• Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
• Bismuth Subsalicylate
• Bismuth Subsalicylate; Metronidazole; Tetracycline
• Bisoprolol; Hydrochlorothiazide, HCTZ
• Boceprevir
• Bortezomib
• Brexpiprazole
• Brigatinib
• Brimonidine
• Brimonidine; Brinzolamide
• Brimonidine; Timolol
• Brivaracetam
• Bromocriptine
• Brompheniramine
• Brompheniramine; Carbetapentane; Phenylephrine
• Brompheniramine; Dextromethorphan; Guaifenesin
• Brompheniramine; Guaifenesin; Hydrocodone
• Brompheniramine; Hydrocodone; Pseudoephedrine
• Brompheniramine; Pseudoephedrine
• Budesonide
• Budesonide; Formoterol
• Bupivacaine
• Bupivacaine Liposomal
• Bupivacaine; Lidocaine
• Buprenorphine
• Buprenorphine; Naloxone
• Bupropion
• Bupropion; Naltrexone
• Buspirone
• Busulfan
• Butabarbital
• Butorphanol
• Caffeine
• Caffeine; Ergotamine
• Calcifediol
• Calcitriol
• Candesartan; Hydrochlorothiazide, HCTZ
• Cannabidiol
• Capmatinib
• Captopril; Hydrochlorothiazide, HCTZ
• Carbamazepine
• Carbetapentane; Chlorpheniramine
• Carbetapentane; Chlorpheniramine; Phenylephrine
• Carbetapentane; Diphenhydramine; Phenylephrine
• Carbetapentane; Guaifenesin
• Carbetapentane; Guaifenesin; Phenylephrine
• Carbetapentane; Phenylephrine
• Carbetapentane; Phenylephrine; Pyrilamine
• Carbetapentane; Pseudoephedrine
• Carbetapentane; Pyrilamine
• Carbidopa; Levodopa; Entacapone
• Carbinoxamine
• Carbinoxamine; Dextromethorphan; Pseudoephedrine
• Carbinoxamine; Hydrocodone; Phenylephrine
• Carbinoxamine; Hydrocodone; Pseudoephedrine
• Carbinoxamine; Phenylephrine
• Carbinoxamine; Pseudoephedrine
• Cardiac glycosides
• Cariprazine
• Cenobamate
• Cetirizine
• Cetirizine; Pseudoephedrine
• Cevimeline
• Charcoal
• Chlophedianol; Dexchlorpheniramine; Pseudoephedrine
• Chlorambucil
• Chloramphenicol
• Chlordiazepoxide
• Chlordiazepoxide; Clidinium
• Chloroprocaine
• Chlorothiazide
• Chlorpheniramine
• Chlorpheniramine; Codeine
• Chlorpheniramine; Dextromethorphan
• Chlorpheniramine; Dextromethorphan; Phenylephrine
• Chlorpheniramine; Dihydrocodeine; Phenylephrine
• Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
• Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
• Chlorpheniramine; Hydrocodone
• Chlorpheniramine; Hydrocodone; Phenylephrine
• Chlorpheniramine; Hydrocodone; Pseudoephedrine
• Chlorpheniramine; Phenylephrine
• Chlorpheniramine; Pseudoephedrine
• Chlorthalidone
• Chlorthalidone; Clonidine
• Cholestyramine
• Choline Salicylate; Magnesium Salicylate
• Cinacalcet
• Citalopram
• Clemastine
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Cobimetinib
• Codeine
• Codeine; Guaifenesin
• Codeine; Phenylephrine; Promethazine
• Codeine; Promethazine
• COMT inhibitors
• Conjugated Estrogens
• Conjugated Estrogens; Bazedoxifene
• Conjugated Estrogens; Medroxyprogesterone
• Cyclophosphamide
• Cyclosporine
• Cyproheptadine
• Dapsone
• Darifenacin
• Darunavir
• Darunavir; Cobicistat
• Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Deflazacort
• Delavirdine
• Deutetrabenazine
• Dexamethasone
• Dexchlorpheniramine
• Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
• Dexmedetomidine
• Dextromethorphan; Diphenhydramine; Phenylephrine
• Dextromethorphan; Quinidine
• Diazepam
• Diclofenac
• Diclofenac; Misoprostol
• Dienogest; Estradiol valerate
• Diethylstilbestrol, DES
• Diflunisal
• Dihydrocodeine; Guaifenesin; Pseudoephedrine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenhydramine; Hydrocodone; Phenylephrine
• Diphenhydramine; Ibuprofen
• Diphenhydramine; Naproxen
• Diphenhydramine; Phenylephrine
• Disopyramide
• Dolutegravir; Rilpivirine
• Donepezil
• Donepezil; Memantine
• Doravirine
• Doravirine; Lamivudine; Tenofovir disoproxil fumarate
• Doxercalciferol
• Doxorubicin
• Doxycycline
• Doxylamine
• Doxylamine; Pyridoxine
• Dronabinol
• Dronedarone
• Droperidol
• Drospirenone; Estradiol
• Drospirenone; Ethinyl Estradiol
• Drospirenone; Ethinyl Estradiol; Levomefolate
• Efavirenz
• Efavirenz; Emtricitabine; Tenofovir
• Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
• Elagolix; Estradiol; Norethindrone acetate
• Elbasvir; Grazoprevir
• Eltrombopag
• Empagliflozin; Linagliptin
• Empagliflozin; Linagliptin; Metformin
• Emtricitabine; Rilpivirine; Tenofovir alafenamide
• Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
• Enalapril; Felodipine
• Enalapril; Hydrochlorothiazide, HCTZ
• Encorafenib
• Entacapone
• Entrectinib
• Eprosartan; Hydrochlorothiazide, HCTZ
• Erdafitinib
• Erlotinib
• Escitalopram
• Esketamine
• Eslicarbazepine
• Esomeprazole
• Esomeprazole; Naproxen
• Estazolam
• Esterified Estrogens
• Esterified Estrogens; Methyltestosterone
• Estradiol
• Estradiol Cypionate; Medroxyprogesterone
• Estradiol; Levonorgestrel
• Estradiol; Norethindrone
• Estradiol; Norgestimate
• Estradiol; Progesterone
• Estrogens
• Estropipate
• Eszopiclone
• Ethanol
• Ethinyl Estradiol
• Ethinyl Estradiol; Desogestrel
• Ethinyl Estradiol; Ethynodiol Diacetate
• Ethinyl Estradiol; Etonogestrel
• Ethinyl Estradiol; Levonorgestrel
• Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
• Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
• Ethinyl Estradiol; Norelgestromin
• Ethinyl Estradiol; Norethindrone
• Ethinyl Estradiol; Norethindrone Acetate
• Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
• Ethinyl Estradiol; Norethindrone; Ferrous fumarate
• Ethinyl Estradiol; Norgestimate
• Ethinyl Estradiol; Norgestrel
• Ethosuximide
• Exenatide
• Ezetimibe; Simvastatin
• Fedratinib
• Felodipine
• Fenoprofen
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine; Olanzapine
• Fluticasone
• Fluticasone; Salmeterol
• Fluticasone; Umeclidinium; Vilanterol
• Fluticasone; Vilanterol
• food
• Fosamprenavir
• Fosinopril; Hydrochlorothiazide, HCTZ
• Gabapentin
• Galantamine
• Gallium Ga 68 Dotatate
• General anesthetics
• Glasdegib
• Glimepiride
• Glimepiride; Pioglitazone
• Glimepiride; Rosiglitazone
• Green Tea
• Griseofulvin
• Guaifenesin; Hydrocodone
• Guaifenesin; Hydrocodone; Pseudoephedrine
• Guanfacine
• Haloperidol
• Hemin
• Homatropine; Hydrocodone
• Hydantoins
• Hydralazine; Hydrochlorothiazide, HCTZ
• Hydrochlorothiazide, HCTZ
• Hydrochlorothiazide, HCTZ; Irbesartan
• Hydrochlorothiazide, HCTZ; Lisinopril
• Hydrochlorothiazide, HCTZ; Losartan
• Hydrochlorothiazide, HCTZ; Methyldopa
• Hydrochlorothiazide, HCTZ; Metoprolol
• Hydrochlorothiazide, HCTZ; Moexipril
• Hydrochlorothiazide, HCTZ; Olmesartan
• Hydrochlorothiazide, HCTZ; Propranolol
• Hydrochlorothiazide, HCTZ; Quinapril
• Hydrochlorothiazide, HCTZ; Spironolactone
• Hydrochlorothiazide, HCTZ; Telmisartan
• Hydrochlorothiazide, HCTZ; Triamterene
• Hydrochlorothiazide, HCTZ; Valsartan
• Hydrocodone
• Hydrocodone; Ibuprofen
• Hydrocodone; Phenylephrine
• Hydrocodone; Potassium Guaiacolsulfonate
• Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
• Hydrocodone; Pseudoephedrine
• Hydromorphone
• Hydroxyprogesterone
• Hydroxyzine
• Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
• Ibuprofen; Oxycodone
• Ifosfamide
• Iloperidone
• Imatinib
• Indinavir
• Insulin Glargine; Lixisenatide
• Isavuconazonium
• Isocarboxazid
• Isoniazid, INH
• Isoniazid, INH; Pyrazinamide, PZA; Rifampin
• Isoniazid, INH; Rifampin
• Isradipine
• Itraconazole
• Ivabradine
• Ixabepilone
• Ketoconazole
• Lamivudine, 3TC; Zidovudine, ZDV
• Lamotrigine
• Lansoprazole
• Lansoprazole; Naproxen
• Lanthanum Carbonate
• Lasmiditan
• Lefamulin
• Lemborexant
• Lesinurad
• Lesinurad; Allopurinol
• Leucovorin
• Levobupivacaine
• Levocetirizine
• Levoleucovorin
• Levorphanol
• Lidocaine
• Lidocaine; Prilocaine
• Linagliptin
• Linagliptin; Metformin
• Lithium
• Lixisenatide
• Lofexidine
• Lomitapide
• Lopinavir; Ritonavir
• Lorazepam
• Lorlatinib
• Lovastatin
• Lovastatin; Niacin
• Loxapine
• Lumateperone
• Lurasidone
• Magnesium Salicylate
• Magnesium Salts
• Mannitol
• Maprotiline
• Mebendazole
• Meclizine
• Mefloquine
• Melatonin
• Meperidine
• Meperidine; Promethazine
• Mephobarbital
• Mepivacaine
• Mepivacaine; Levonordefrin
• Meprobamate
• Mestranol; Norethindrone
• Metformin; Repaglinide
• Methadone
• Methazolamide
• Methocarbamol
• Methohexital
• Methscopolamine
• Methsuximide
• Methyclothiazide
• Methylprednisolone
• Metoclopramide
• Metolazone
• Metronidazole
• Metyrapone
• Metyrosine
• Mexiletine
• Midazolam
• Minocycline
• Mipomersen
• Mirtazapine
• Mitotane
• Modafinil
• Monoamine oxidase inhibitors
• Morphine
• Morphine; Naltrexone
• Nabilone
• Nalbuphine
• Nanoparticle Albumin-Bound Paclitaxel
• Nelfinavir
• Neratinib
• Nevirapine
• Niacin; Simvastatin
• Nicardipine
• Nifedipine
• Nimodipine
• Nintedanib
• Nisoldipine
• Olanzapine
• Olaparib
• Ombitasvir; Paritaprevir; Ritonavir
• Omeprazole
• Omeprazole; Amoxicillin; Rifabutin
• Omeprazole; Sodium Bicarbonate
• Ondansetron
• Oxazepam
• Oxybutynin
• Oxycodone
• Oxymorphone
• Paclitaxel
• Paliperidone
• Papaverine
• Paroxetine
• Pemigatinib
• Penicillin G Benzathine; Penicillin G Procaine
• Penicillin G Procaine
• Pentazocine
• Pentazocine; Naloxone
• Pentobarbital
• Perampanel
• Perindopril; Amlodipine
• Phenelzine
• Phenobarbital
• Phenothiazines
• Phentermine; Topiramate
• Pimavanserin
• Pneumococcal Vaccine, Polyvalent
• Pomalidomide
• Posaconazole
• Pralidoxime
• Pramipexole
• Pramlintide
• Prednisolone
• Prednisone
• Pregabalin
• Prilocaine
• Prilocaine; Epinephrine
• Primidone
• Procarbazine
• Progestins
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Rabeprazole
• Ramelteon
• Ranolazine
• Rasagiline
• Red Yeast Rice
• Remifentanil
• Repaglinide
• Reserpine
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Riluzole
• Rimegepant
• Risperidone
• Ritonavir
• Roflumilast
• Romidepsin
• Ropinirole
• Ropivacaine
• Rotigotine
• Safinamide
• Salicylates
• Salsalate
• Saquinavir
• Scopolamine
• Secobarbital
• Segesterone Acetate; Ethinyl Estradiol
• Selegiline
• Selpercatinib
• Selumetinib
• Sertraline
• Sildenafil
• Simvastatin
• Simvastatin; Sitagliptin
• Siponimod
• Sirolimus
• Skeletal Muscle Relaxants
• Sodium Bicarbonate
• Sodium Oxybate
• Spironolactone
• St. John’s Wort, Hypericum perforatum
• Sufentanil
• Sulfinpyrazone
• Sunitinib
• Suvorexant
• Tacrolimus
• Tapentadol
• Tasimelteon
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Temazepam
• Terbinafine
• Tetrabenazine
• Tetracaine
• Thalidomide
• Theophylline, Aminophylline
• Thiazide diuretics
• Thiopental
• Thiothixene
• Thyroid hormones
• Tipranavir
• Tizanidine
• tobacco
• Tolcapone
• Topiramate
• Tramadol
• Trandolapril; Verapamil
• Tranylcypromine
• Trazodone
• Tretinoin, ATRA
• Triamcinolone
• Triazolam
• Tricyclic antidepressants
• Trimethobenzamide
• Trimetrexate
• Triprolidine
• Ubrogepant
• Ulipristal
• Valbenazine
• Valerian, Valeriana officinalis
• Valproic Acid, Divalproex Sodium
• Vemurafenib
• Verapamil
• Vigabatrin
• Vincristine
• Vincristine Liposomal
• Vorapaxar
• Voriconazole
• Vortioxetine
• Voxelotor
• Warfarin
• Zaleplon
• Zanubrutinib
• Ziconotide
• Zidovudine, ZDV
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zonisamide