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Acetaminophen And Ibuprofen

Also known as: Combogesic

Nonsteroidal Anti-inflammatory DrugCyclooxygenase Inhibitors

Route: Oral

Check Acetaminophen And Ibuprofen Interactions →

4 interactions on record⛔ Black Box Warning

Acetaminophen And Ibuprofen has 4 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Acetylsalicylic Acid, Warfarin, Furosemide. Patients taking Acetaminophen And Ibuprofen should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 2
Moderate: 2

Major (2)

Acetaminophen And Ibuprofen + Acetylsalicylic Acid— Concomitant use of ibuprofen and aspirin increases risk of GI adverse reactions and bleeding; no greater therapeutic ben…
Acetaminophen And Ibuprofen + Warfarin— Ibuprofen and warfarin have synergistic effect on bleeding with increased risk of serious bleeding compared to either dr…

Moderate (2)

Acetaminophen And Ibuprofen + Furosemide— NSAIDs reduce natriuretic effect of loop diuretics like furosemide in some patients.
Acetaminophen And Ibuprofen + Propranolol— Ibuprofen may diminish antihypertensive effect of beta-blockers like propranolol and potentially deteriorate renal funct…

Acetaminophen And Ibuprofen + Acetylsalicylic Acid⚠️Major

Concomitant use of ibuprofen and aspirin increases risk of GI adverse reactions and bleeding; no greater therapeutic benefit than NSAID alone.

Acetaminophen And Ibuprofen + Warfarin⚠️Major

Ibuprofen and warfarin have synergistic effect on bleeding with increased risk of serious bleeding compared to either drug alone.

Acetaminophen And Ibuprofen + Furosemide🟡Moderate

NSAIDs reduce natriuretic effect of loop diuretics like furosemide in some patients.

Acetaminophen And Ibuprofen + Propranolol🟡Moderate

Ibuprofen may diminish antihypertensive effect of beta-blockers like propranolol and potentially deteriorate renal function in elderly or volume-depleted patients.

⛔ FDA Black Box Warning

WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, AND GASTROINTESTINAL RISK WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK AND GASTROINTESTINAL RISK See full prescribing information for complete boxed warning . COMBOGESIC contains acetaminophen, which has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with doses of acetaminophen that exceed 4,000 milligrams per day, and often involve more than one acetaminophen containing product ( 5.1 ). Nonsteroidal anti-inflammatory drugs (NSAIDS), like the ibuprofen in COMBOGESIC, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.2 ). COMBOGESIC tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 5.2 ). NSAIDS, like the ibuprofen in COMBOGESIC, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.3 ). HEPATOTOXICITY COMBOGESIC contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1) ] . CARDIOVASCULAR RISK COMBOGESIC contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, whi

Contraindications

4 CONTRAINDICATIONS COMBOGESIC is contraindicated in: patients with a known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product [see Warnings and Precautions (5.7 , 5.8 , 5.9) ]. patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDS [see Warnings and Precautions (5.7 and 5.8) ] . the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2) ] . COMBOGESIC is contraindicated in: patients with known hypersensitivity to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product ( 4 ). patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients ( 4 ). the setting of coronary artery bypass graft (CABG) surgery ( 4 ).

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Ibuprofen Use of NSAID-containing products, including COMBOGESIC, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of COMBOGESIC use between about 20 and 30 weeks of gestation and avoid COMBOGESIC use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations , Data ). Premature Closure of Fetal Ductus Arteriosus: Use of NSAID-containing products, including COMBOGESIC, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Use of NSAID-containing products, including COMBOGESIC, at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimester of pregnancy are inconclusive. In published animal reproduction studies, there were no clear developmental effects at doses up to 2.7-times the maximum human daily dose (MHDD) in the rabbit and 1.5-times in the MHDD rat when dosed throughout gestation. In contrast, an increase in membranous ventricular septal defects was reported in rats treated on Gestation Days 9 & 10 with 2.2-times the MHDD. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.