Eravacycline 100mg powder for solution for infusion vials

The most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting [FDA label]. Less common (incidence ≥ 1%) adverse effects are palpitations, chest pain, acute pancreatitis, pancreatic necrosis, hypocalcemia, dizziness, dysgeusia, anxiety, insomnia, depression, pleural effusion, dyspnea, rash and hyperhidrosis [FDA label].

The following are various side effects that may occur due to eravacycline use [FDA label]:

Hypersensitivity: Life-threatening anaphylaxis has been reported with the administration of eravacycline. Antibacterial drugs and should be avoided in patients with known hypersensitivity to tetracycline-class antibacterial drugs [FDA label].

Tooth Discoloration/enamel hypoplasia: The use of this drug during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may lead to the permanent discoloration of teeth (yellow-grey-brown) [FDA label].

Inhibition of bone growth: The use of eravacycline during the second and third trimester of pregnancy, infancy and childhood until the age of 8 years old may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in bone-forming tissue [FDA label].

Clostridium difficile-Associated diarrhea: Clostridium difficile associated diarrhea (CDAD) has been reported with use of the majority of antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents changes the normal flora of the colon, leading to an overgrowth of C. difficile.

Tetracycline class adverse reactions: This drug is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial agents, and may occur with eravacycline. Discontinue eravacycline if any of these adverse reactions are suspected or observed [FDA label].

Potential for microbial overgrowth: The use of eravacycline may result in overgrowth of non-susceptible organisms, including fungi.

If such infections occur, discontinue eravacycline and manage with appropriate therapy [FDA label].

Development of drug-resistant bacteria: Prescribing eravacycline in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [FDA label].