Excessive sedation may occur when promethazine is combined with other medications that depress the central nervous system (brain) and cause sedation. Such drugs include ethanol, barbiturates, anti-anxiety medications, sedatives, other phenothiazines, and narcotic pain medications.

There may be an increase in the risk of certain neurologic reactions that affect movement of muscles (EPS, see below) when promethazine is combined with medicines that also cause EPS. Such drugs include antipsychotics, metoclopramide (Reglan), and amoxapine (Asendin).

Promethazine should not be used with propylthiouracil (PTU) due to the increased risk of low white blood cell counts and increased risk of infections. The reason for this interaction is not known.

Concurrent use of promethazine with the dye used for myelography (x-rays of the spinal cord) can lower the threshold for seizures and thus increase the risk of seizures. Promethazine should be stopped at least 48 hours before myelography and not restarted until at least 24 hours after myelography.

PREGNANCY: There are no adequate studies of promethazine in pregnant women. Administration of promethazine within 2 weeks of delivery may affect platelet function in the newborn.

NURSING MOTHERS: It is not known whether promethazine is excreted in breast-milk.

SIDE EFFECTS: Promethazine often causes sedation. In children less than two it can depress respiration and lead to death. Therefore, it should not be used in children less than two years old. Dizziness may also occur. Ironically, promethazine sometimes stimulates patients, particularly children. Such stimulation may be manifest by restlessness, inability to sleep, heart palpitations or even seizures. Promethazine also causes anticholinergic side effects such as blurred vision, dry mouth, dilated pupils, nausea, urinary retention (inability to urinate), impotence, and constipation.

EPS may occur. EPS are categorized as dystonic reactions (alterations in muscle tone), sharp, involuntary muscle movements (often limited to one muscle or muscle group), akathisia (subjective restlessness), and Parkinsonism. Parkinsonian symptoms are more common in older persons whereas children more often develop involuntary muscle movement reactions. Dystonic reactions are most commonly seen during the first week of treatment. Restlessness and Parkinsonian symptoms usually develop days to weeks after starting therapy.

A complex called neuroleptic malignant syndrome (NMS) can occur in patients receiving phenothiazines. NMS consists of high body temperature, severe EPS, changes in consciousness and mental status, and increased heart rate with low or high blood pressure. NMS occurs more frequently in young men and in persons who are dehydrated.

Rarely, blood cell disorders can occur; low white cell counts can lead to severe infections.

Phenothiazines such as promethazine can cause skin hyperpigmentation (darkening) but usually only after prolonged use. The effect usually is restricted to areas of the body exposed to sunlight. Thus, people who need long-term treatment with promethazine should either keep out of the sun or use effective sunscreens.

Phenothiazines can cause blurred vision, difficulty with nighttime vision, or changes in color vision.

Liver damage has been reported rarely with phenothiazines. Jaundice is possible. Jaundice also may occur in newborns of mothers who receive phenothiazines during pregnancy.

Phenothiazines such as promethazine block dopamine receptors. This effect can lead to increases in blood levels of prolactin, a hormone involved in lactation (formation of breast milk). As a result, phenothiazines can cause the breast to produce fluid ("milk") even when a woman is not pregnant. Additionally, phenothiazines can cause missed menstrual periods, breast enlargement or tenderness, loss of sexual drive, impotence, inability to ejaculate, and priapism. Weight gain also may occur.

Reference: FDA Prescribing Information

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