Know your risk: How to stay safe from serious medicine side-effects

From skin rashes to seizures, here's how to spot adverse drug reactions early and protect yourself with timely medical action

Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi said India now ranks among the top contributors globally in reporting adverse drug reactions (ADR). This is a reminder that even everyday medicines can carry hidden risks. But what exactly is an ADR, and how do you know if you’re experiencing one?

 

What is an ADR, and is it the same as a side-effect?

 

According to experts, all side-effects are ADRs, but not all ADRs are just side-effects.

 

Dr Tushar Tayal, Associate Director, Internal Medicine, CK Birla Hospital, Gurugram, explains:

 

Side-effect is the expected, often mild “extra” impact of a medicine. Example: mild nausea after antibiotics, or drowsiness with some painkillers. ADR, on the other hand, is the bigger umbrella term. It includes both the expected and the rare, sometimes serious reactions, like a severe rash, liver damage, or difficulty in breathing.

 

Are all ADRs dangerous?

 

“Not always,” said Dr Tayal. “Some are as mild as an upset stomach. But even ‘mild’ matters because they can mess with how you take your meds, which can spiral into bigger health issues.”

 

On the other end of the spectrum are ADRs that can be life-threatening such as severe allergic reactions, high fever with skin peeling, or yellowing of the eyes (a liver warning sign).

 

What are the early warning signs of ADRs?

 

Here are early warning signs to never ignore:

 

• New rashes, hives, or swelling on your face/lips
• Sudden breathlessness or fast heartbeat
• High fever, mouth sores, or peeling skin
• Yellow skin or eyes, dark urine
• Severe stomach pain, nonstop vomiting or loose motions
• Unusual bleeding, bruising, or seizures

 

How do ADRs differ depending on the medicine?

• Antibiotics: Mild diarrhoea or nausea is common. Rarely, they can cause dangerous skin reactions or severe gut infections
• Painkillers (NSAIDs, opioids): Ibuprofen can upset your stomach, harm kidneys, or (rarely) cause severe skin reactions. Opioids may cause drowsiness or suppress breathing
• Cancer drugs: Higher risk of organ damage, infections, and severe nausea
• Vaccines/biologics: Usually just fever or soreness. Rarely, the immune system overreacts

 

“And let’s not forget the OTC culture in India. From antibiotics, painkillers, to some herbal medicines, people often consume without a prescription, making ADRs more likely,” said Dr Tayal.

 

Who is at higher risk of ADRs?

 

According to Dr Tayal, kids, older adults, and people with chronic illnesses are at high risk:

 

• Kids: Their bodies process drugs differently; even a small miscalculation in dose can trigger a reaction
• Older adults: Slower drug clearance + multiple medicines = double trouble
• Chronic illness patients: Heart, liver, or kidney problems can make medicines accumulate dangerously

 

He further said genes, diet, and herbal teas can also influence how your medicine behaves:

 

• Genetics: Some people lack enzymes needed to process drugs, which leads to unexpected toxicity
• Diet: Grapefruit juice, cranberries, alcohol, or herbal products can mess with drug metabolism
• Co-existing diseases: Liver, kidney, or heart conditions make ADRs more likely

 

How does India track adverse drug reactions?

 

India has a system called the Pharmacovigilance Programme of India (PvPI), established in 2010 under the Ministry of Health and Family Welfare. It collects reports from hospitals, doctors, pharmacists, and even patients. These reports feed into global safety databases. Due to this initiative, India is now among the top global contributors in ADR reporting, which is a sign that awareness is growing.

 

What should you do if you suspect an ADR?

 

Dr Tayal suggests calling your doctor or rushing to the nearest hospital if it is severe (breathing trouble, seizures, swelling, heavy bleeding).

 

He recommends not abruptly stopping medicines without advice, especially for heart or seizure conditions. He advises keeping a record of the medicine name, dose, start date, other drugs/supplements taken, and even photos of rashes.

 

“This helps doctors treat you faster and ensures your case gets reported properly,” he said.

 

How can you report an ADR in India?

 

The Indian Pharmacopoeia Commission (IPC) has launched:

 

• A toll-free IVRS helpline: 1800-180-3024
• Email: pvpi.ipc@gov.in
• Android app: ADR PvPI
• ADR forms downloadable via IPC and CDSCO websites, which can be submitted to a nearby monitoring centre

   

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This content is for informational purposes only and is not a substitute for professional medical advice.